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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04686136
Registration number
NCT04686136
Ethics application status
Date submitted
21/12/2020
Date registered
28/12/2020
Titles & IDs
Public title
A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
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Scientific title
A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine
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Secondary ID [1]
0
0
2020-002470-27
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Secondary ID [2]
0
0
3101-312-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer
0
0
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Episodic Migraine
0
0
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Chronic Migraine
0
0
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Neoplasms, Lung
0
0
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Neoplasms, Pulmonary
0
0
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Pulmonary Cancer
0
0
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Pulmonary Neoplasms
0
0
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Condition category
Condition code
Neurological
0
0
0
0
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Other neurological disorders
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Cancer
0
0
0
0
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Non melanoma skin cancer
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Cancer
0
0
0
0
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Kidney
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Cancer
0
0
0
0
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Lung - Mesothelioma
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Cancer
0
0
0
0
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Lung - Non small cell
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Cancer
0
0
0
0
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Lung - Small cell
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Cancer
0
0
0
0
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Bowel - Back passage (rectum) or large bowel (colon)
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Musculoskeletal
0
0
0
0
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Other muscular and skeletal disorders
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Human Genetics and Inherited Disorders
0
0
0
0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atogepant 60 mg
Treatment: Drugs - JDQ443
Treatment: Drugs - TNO155
Treatment: Other - tislelizumab
Experimental: Atogepant 60 mg - Taken once daily
Experimental: Arm A - JDQ443
Experimental: Arm B - JDQ443 in combination with TNO155
Experimental: Arm C - JDQ443 in combination with tislelizumab
Experimental: Arm D - JDQ443 in combination with TNO155 and tislelizumab
Treatment: Drugs: Atogepant 60 mg
Tablets containing 60 mg of Atogepant
Treatment: Drugs: JDQ443
KRAS G12C inhibitor
Treatment: Drugs: TNO155
SHP2 inhibitor
Treatment: Other: tislelizumab
Anti PD1 antibody
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Intervention code [1]
0
0
Treatment: Drugs
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Intervention code [2]
0
0
Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
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Assessment method [1]
0
0
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Timepoint [1]
0
0
156 weeks
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Primary outcome [2]
0
0
Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
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Assessment method [2]
0
0
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment
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Timepoint [2]
0
0
21 days
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Primary outcome [3]
0
0
Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
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Assessment method [3]
0
0
All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs).
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Timepoint [3]
0
0
24 months
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Primary outcome [4]
0
0
Dose Escalation: Frequency of dose interruptions and reductions, by treatment
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Assessment method [4]
0
0
Tolerability of study drug will be assessed by summarizing the number of and reason for dose delays and dose reductions.
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Timepoint [4]
0
0
24 months
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Primary outcome [5]
0
0
Dose Escalation: Dose intensity by treatment
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Assessment method [5]
0
0
Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of treatment.
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Timepoint [5]
0
0
24 months
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Primary outcome [6]
0
0
Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment
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Assessment method [6]
0
0
Overall response rate is defined as the proportion of patients with a BOR of CR or PR according to RECIST 1.1, and will be summarized along with the corresponding 95% exact binomial confidence interval (CI). Applies to all groups except the brain metastasis group.
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Timepoint [6]
0
0
24 months
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Primary outcome [7]
0
0
Dose expansion: Overall intracranial response rate (OIRR) per mRANO-BM
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Assessment method [7]
0
0
OIRR per mRANO-BM is defined as the proportion of participants with a best overall intracranial response (BOIR) of CR or PR according to mRANO-BM criteria, and will be summarized along with the corresponding 90% and 95% exact CI. Applies to brain metastasis group only.
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Timepoint [7]
0
0
24 months
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Primary outcome [8]
0
0
Dose expansion: Incidence and severity of AEs and SAEs
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Assessment method [8]
0
0
All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs). Applies to JDQ443 dose randomization group only.
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Timepoint [8]
0
0
24 months
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Primary outcome [9]
0
0
Dose expansion: frequency of dose interruptions and reductions, by treatment
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Assessment method [9]
0
0
Tolerability of study drug will be assessed by summarizing the number of and reason for dose delays and dose reductions. Applies to JDQ443 dose randomization group only.
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Timepoint [9]
0
0
24 months
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Primary outcome [10]
0
0
Dose expansion: Dose intensity by treatment
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Assessment method [10]
0
0
Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of treatment. Applies to JDQ443 dose randomization group only
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Timepoint [10]
0
0
24 months
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Primary outcome [11]
0
0
Dose expansion: ORR per RECIST 1.1 of JDQ443 single agent in patients with non-small cell lung cancer (JDQ443 dose randomization group only)
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Assessment method [11]
0
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Overall response rate is defined as the proportion of patients with BOR of CR or PR according to RECIST 1.1, and will be summarized along with the corresponding 95% exact binomial confidence interval (CI). Applies to JDQ443 dose randomization group only
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Timepoint [11]
0
0
24 months
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Secondary outcome [1]
0
0
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
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Assessment method [1]
0
0
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Timepoint [1]
0
0
156 weeks
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Secondary outcome [2]
0
0
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
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Assessment method [2]
0
0
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Timepoint [2]
0
0
156 weeks
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Secondary outcome [3]
0
0
Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
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Assessment method [3]
0
0
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Timepoint [3]
0
0
156 weeks
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Secondary outcome [4]
0
0
Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales
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Assessment method [4]
0
0
A clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior)
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Timepoint [4]
0
0
156 weeks
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Secondary outcome [5]
0
0
Dose Escalation and Expansion: ORR per RECIST v1.1
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Assessment method [5]
0
0
Overall response rate is defined as the proportion of patients with a BOR of CR or PR according to RECIST 1.1, and will be summarized along with the corresponding 95% exact binomial confidence interval (CI)
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Timepoint [5]
0
0
24 months
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Secondary outcome [6]
0
0
Dose Escalation and Expansion: Best Overall Response (BOR) per RECIST v1.1
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Assessment method [6]
0
0
BOR is defined as the best overall confirmed response recorded from the start of the treatment until disease progression/recurrence.
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Timepoint [6]
0
0
24 months
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Secondary outcome [7]
0
0
Dose Escalation and Expansion: Progression-free survival (PFS) per RECIST v1.1, Overall Survival (OS)
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Assessment method [7]
0
0
Per RECIST 1.1, PFS is defined as the time from the date of start of treatment to the date of the first documented progression, or death. If patient has not had an event, PFS will be censored at the date of last adequate tumor assessment. PFS will be summarized using the Kaplan-Meier method, along with 95% CI
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Timepoint [7]
0
0
24 months
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Secondary outcome [8]
0
0
Dose Escalation and Expansion: Duration of Response (DOR) per RECIST v1.1
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Assessment method [8]
0
0
Duration of response is defined as the time from the date of the first documented response (CR or PR), to the date of first documented progression, or death due any cause. Estimates will use Kaplan-Meier method, and median DOR and corresponding 95% CI will be presented.
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Timepoint [8]
0
0
24 months
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Secondary outcome [9]
0
0
Dose Escalation and Expansion: Disease Control Rate (DCR) per RECIST v1.1
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Assessment method [9]
0
0
The disease control rate is calculated as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease. It will be summarized along with the corresponding 95% exact CI
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Timepoint [9]
0
0
24 months
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Secondary outcome [10]
0
0
Dose Escalation and Expansion: Plasma or serum concentration vs time profiles (AUC) by treatment
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Assessment method [10]
0
0
AUC is defined as area under the plasma or serum concentration versus time curve after a dose of JDQ443, TNO155 and tislelizumab
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Timepoint [10]
0
0
Up to 24 months
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Secondary outcome [11]
0
0
Dose Escalation and Expansion: Plasma concentration (Cmax) by treatment
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Assessment method [11]
0
0
Cmax is defined as the maximum observed plasma or serum drug concentration after single dose administration.
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Timepoint [11]
0
0
Up to 24 months
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Secondary outcome [12]
0
0
Dose Escalation and Expansion: Time to achieve Cmax (Tmax) by treatment
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Assessment method [12]
0
0
Tmax is defined as the time to reach maximum plasma or serum drug concentration after single dose administration.
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Timepoint [12]
0
0
Up to 24 months
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Secondary outcome [13]
0
0
Dose Escalation and Expansion: Antidrug antibody (ADA) incidence by treatment
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Assessment method [13]
0
0
To evaluate the immunogenicity of tislelizumab when dosed in combination with JDQ443 and/or TNO155 - only applicable to Arms C and D
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Timepoint [13]
0
0
Up to 24 months
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Secondary outcome [14]
0
0
Dose Expansion: Dose intensity by treatment
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Assessment method [14]
0
0
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Timepoint [14]
0
0
24 months
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Secondary outcome [15]
0
0
Dose Expansion: Frequency of dose interruptions and reductions, by treatment
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Assessment method [15]
0
0
Tolerability of study drug will be assessed by summarizing the number of and reason for dose delays and dose reductions.
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Timepoint [15]
0
0
24 months
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Secondary outcome [16]
0
0
Dose Expansion: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
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Assessment method [16]
0
0
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment
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Timepoint [16]
0
0
21 days
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Secondary outcome [17]
0
0
Dose Expansion: Incidence and severity of AEs and SAEs by treatment
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Assessment method [17]
0
0
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Timepoint [17]
0
0
24 months
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Secondary outcome [18]
0
0
Dose expansion: Intracranial disease control rate (IDCR) per mRANO-BM
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Assessment method [18]
0
0
IDCR is the proportion of participants with a confirmed BOIR of CR or PR or SD (or non-CR/non-PD) per mRANO-BM criteria. It will be summarized along with the corresponding 90% and 95% CI. Applies to the brain metastasis group only.
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Timepoint [18]
0
0
24 months
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Secondary outcome [19]
0
0
Dose expansion: Best overall intracranial response (BOIR) per mRANO-BM
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Assessment method [19]
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0
BOIR is defined as the best overall confirmed response recorded from the start of the treatment until disease progression/recurrence per mRANO-BM, or until patient comes off study, whichever comes first. BOIR will be summarized along with the corresponding 95% exact CI. Applies to the brain metastasis group only.
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Timepoint [19]
0
0
24 months
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Secondary outcome [20]
0
0
Dose expansion: Intracranial progression free survival (IPFS) per mRANO-BM
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Assessment method [20]
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0
IPFS is defined as the time from the date of start of treatment to the date of the first documented progression per mRANO-BM, or death due to any cause. If a patient has not had an event, IPFS will be censored at the date of last adequate tumor assessment. IPFS will be summarized using the Kaplan-Meier method. Median IPFS and IPFS probability at pre specified time-points will be presented along with 95% CI. Applies to the brain metastasis group only.
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Timepoint [20]
0
0
24 months
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Secondary outcome [21]
0
0
Dose expansion: Duration of intracranial response (DOIR) per mRANO-BM
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Assessment method [21]
0
0
DOIR is defined as the time from the date of first documented intracranial response of either CR or PR to the date of the first documented intracranial progression as per mRANO-BM criteria as assessed by central review or date of death due to underlying cause of cancer. DOIR will be summarized using the KM method if data permit. Median DOIR, with corresponding 95% CI. KM estimates for DOIR proportions at specific time points, along with 95% CI will also be provided. Applies to the brain metastasis group only.
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Timepoint [21]
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0
24 months
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Eligibility
Key inclusion criteria
- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative.
* Participants with an ECG indicating clinically significant abnormalities at Visit 1.
* Participants with hypertension at Visit 1.
* Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
* Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/02/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
8/10/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
596
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
0
0
Novartis Investigative Site - Melbourne
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Recruitment postcode(s) [1]
0
0
3000 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Colorado
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Georgia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Indiana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Kansas
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Louisiana
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Maryland
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Massachusetts
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Minnesota
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Mississippi
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Missouri
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Nebraska
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Country [15]
0
0
United States of America
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State/province [15]
0
0
New Mexico
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Country [16]
0
0
United States of America
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State/province [16]
0
0
New York
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Country [17]
0
0
United States of America
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State/province [17]
0
0
North Carolina
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Ohio
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Pennsylvania
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Tennessee
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Country [21]
0
0
United States of America
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State/province [21]
0
0
Texas
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Country [22]
0
0
United States of America
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State/province [22]
0
0
Utah
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Country [23]
0
0
United States of America
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State/province [23]
0
0
Virginia
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Country [24]
0
0
United States of America
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State/province [24]
0
0
Washington
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Country [25]
0
0
Canada
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State/province [25]
0
0
Alberta
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Country [26]
0
0
Canada
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State/province [26]
0
0
British Columbia
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Country [27]
0
0
Canada
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State/province [27]
0
0
Ontario
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Country [28]
0
0
Canada
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State/province [28]
0
0
Quebec
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Country [29]
0
0
Czechia
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State/province [29]
0
0
Hradec Kralove
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Country [30]
0
0
Czechia
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State/province [30]
0
0
Kladno
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Country [31]
0
0
Czechia
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State/province [31]
0
0
Ostrava
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Country [32]
0
0
Czechia
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State/province [32]
0
0
Pardubice
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Country [33]
0
0
Czechia
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State/province [33]
0
0
Plzen
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Country [34]
0
0
Czechia
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State/province [34]
0
0
Prague 10
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Country [35]
0
0
Czechia
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State/province [35]
0
0
Prague
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Country [36]
0
0
Czechia
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State/province [36]
0
0
Praha
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Country [37]
0
0
Czechia
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State/province [37]
0
0
Rychnov nad Kneznou
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Country [38]
0
0
Czechia
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State/province [38]
0
0
Zlin
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Country [39]
0
0
Denmark
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State/province [39]
0
0
Hovedstaden
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Country [40]
0
0
France
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State/province [40]
0
0
Alpes-Maritimes
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Country [41]
0
0
France
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State/province [41]
0
0
Bouches-du-Rhone
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Country [42]
0
0
France
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State/province [42]
0
0
Bron
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Country [43]
0
0
France
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State/province [43]
0
0
Clermont Ferrand
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Country [44]
0
0
France
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State/province [44]
0
0
Paris
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Country [45]
0
0
France
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State/province [45]
0
0
St-Priest-en-Jarez
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Country [46]
0
0
Germany
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State/province [46]
0
0
Niedersachsen
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Country [47]
0
0
Germany
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State/province [47]
0
0
Berlin
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Country [48]
0
0
Germany
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State/province [48]
0
0
Essen
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Country [49]
0
0
Germany
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State/province [49]
0
0
Kassel
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Country [50]
0
0
Germany
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State/province [50]
0
0
Kiel
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Country [51]
0
0
Germany
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State/province [51]
0
0
Leipzig
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Country [52]
0
0
Germany
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State/province [52]
0
0
Ulm
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Country [53]
0
0
Germany
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State/province [53]
0
0
Unterhaching
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???
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Glasgow
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Nippon Shinyaku Co., Ltd.
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Ethics approval
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Summary
Brief summary
This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine
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Trial website
https://clinicaltrials.gov/study/NCT04686136
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Trial related presentations / publications
Lorthiois E, Gerspacher M, Beyer KS, Vaupel A, Leblanc C, Stringer R, Weiss A, Wilcken R, Guthy DA, Lingel A, Bomio-Confaglia C, Machauer R, Rigollier P, Ottl J, Arz D, Bernet P, Desjonqueres G, Dussauge S, Kazic-Legueux M, Lozac'h MA, Mura C, Sorge M, Todorov M, Warin N, Zink F, Voshol H, Zecri FJ, Sedrani RC, Ostermann N, Brachmann SM, Cotesta S. JDQ443, a Structurally Novel, Pyrazole-Based, Covalent Inhibitor of KRASG12C for the Treatment of Solid Tumors. J Med Chem. 2022 Dec 22;65(24):16173-16203. doi: 10.1021/acs.jmedchem.2c01438. Epub 2022 Nov 18.
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04686136