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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05655520
Registration number
NCT05655520
Ethics application status
Date submitted
9/12/2022
Date registered
19/12/2022
Date last updated
2/10/2023
Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease
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Scientific title
A Phase 3, Multicenter, Open-label Safety Study to Evaluate the Long-term Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease
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Secondary ID [1]
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718-CIH-301
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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:
Huntington Disease
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SAGE-718
Experimental: Cohort 1 (Direct Rollover) - Participants from studies 718-CIH-201 (NCT05107128)/202 (NCT05358821) who will sign the informed consent for study 718-CIH-301 =7 days after the last day of the corresponding parent study. Participants will receive Sage-718 from Day 1 up to Day 365.
Experimental: Cohort 2 (Gap Rollover) - Participants from studies 718-CIH-201 (NCT05107128)/202 (NCT05358821) who will sign the informed consent for study 718-CIH-301 after a gap of >7 days after the last day of the corresponding parent study. Participants will receive Sage-718 from Day 1 up to Day 365.
Experimental: Cohort 3 (De Novo) - Participants who were not previously included in any SAGE-718 clinical study. Participants will receive Sage-718 from Day 1 up to Day 365.
Treatment: Drugs: SAGE-718
Oral softgel lipid capsules
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Intervention code [1]
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Treatment: Drugs
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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 Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs
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Assessment method [1]
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An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of Investigational Product (IP), or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Severity will be graded as mild (barely noticeable to the participant/does not make participant uncomfortable); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with significant impact to perform normal activities).
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Timepoint [1]
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Up to 13 months
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Primary outcome [2]
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Number of Participants Who Withdrew Due to Adverse Events (AEs)
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Assessment method [2]
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An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product.
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Timepoint [2]
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Up to 13 months
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Primary outcome [3]
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Percentage of Participants with Change From Baseline in Vital Signs, Clinical Laboratory Parameters and Electrocardiograms (ECGs) Parameters
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Assessment method [3]
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Vital signs will include body temperature, respiratory rate, heart rate and blood pressure. Laboratory parameters will include haematology, biochemistry, coagulation, and urinalysis. ECG parameters such as heart rate, PR, QRS, QT, and QT corrected according to Fridericia's formula [QTcF] will be recorded.
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Timepoint [3]
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Up to 13 months
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Primary outcome [4]
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Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
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Assessment method [4]
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The C-SSRS scale consists of baseline evaluation that assesses lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS includes "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation. If present [from 1 (minor physical damage) to 5 (death), with 5 being most severe]. C-SSRS SI items involve (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involves (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior.
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Timepoint [4]
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Up to 13 months
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Eligibility
Key inclusion criteria
For all participants:
- Completed 718-CIH-201 (NCT05107128) or 718-CIH-202 (NCT05358821) studies or meet
eligibility criteria for the de novo cohort.
- Agree to refrain from drugs of abuse for the duration of the study and from alcohol
during the 48 hours preceding each study visit.
- Be willing to invite a study partner, if available, who is reliable, competent, and at
least 18 years of age to participate in the study.
- Be able to travel to the study center, and, judged by the investigator, is likely to
be able to continue to travel to the study center to complete study visits for the
duration of the study.
Additional inclusion criteria for the de novo cohort (Cohort 3):
- Be at least 25 years old, but not older than 65 years of age at Screening.
- Genetically confirmed disease with cytosine-adenine-guanine (CAG) expansion =40
- No features of juvenile HD
- CAG-Age-Product (CAP) score =90, as calculated using the CAP formula: AGE × (CAG - 30)
/ 6.49.
- Either Unified Huntington's Disease Rating Scale (UHDRS) -Total Functional Capacity
(TFC)=13 or Montreal Cognitive Assessment (MoCA) >25 score at Screening (one or the
other; not both)
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Minimum age
25
Years
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Maximum age
65
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
For all participants
- Have a diagnosis of an ongoing neurodegenerative condition other than HD, including
but not limited to, Alzheimer's Disease, vascular dementia, dementia with Lewy bodies,
or Parkinson's Disease.
- Had gastric bypass surgery, has a gastric sleeve or lap band, or has had any related
procedures that interfere with gastrointestinal transit.
- Is known to be allergic to any of SAGE-718 excipients, including soy lecithin.
- Receive any prohibited medications within 30 days of screening and during
participation in the study.
Additional exclusion criteria for the de novo cohort (Cohort 3):
- Have previous exposure to gene therapy, or have participated in any other HD
investigational drug, biologic, or device trial within 180 days or a non-HD drug,
biologic or device trial within 30 days or 5 half-lives (whichever is longer).
Additionally, participants who have received treatment with antisense oligonucleotides
or a messenger ribonucleic acid (mRNA) splicing modifier will be excluded.
Note: Participants with confirmation of enrolment in the placebo arm of these
investigational trials would not be excluded.
Additional exclusion criteria for 718-CIH-201/202 completers (Cohorts 1 and 2):
- Have ongoing serious adverse events from the parent study.
- Have ongoing, unresolved AE(s), which in the opinion of the investigator or sponsor,
is likely to interfere with study conduct or compliance.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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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
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
14/12/2022
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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
1/12/2025
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Florida
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Illinois
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Iowa
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New York
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Canada
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Ontario
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sage Therapeutics
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary purpose of the study is to evaluate the safety and tolerability of SAGE-718
softgel lipid capsule in participants with Huntington's Disease (HD)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05655520
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Fax
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Email
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Contact person for public queries
Name
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Grant Rutledge, PhD
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Address
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Phone
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339-368-8432
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05655520
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