Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02611713
Registration number
NCT02611713
Ethics application status
Date submitted
19/11/2015
Date registered
23/11/2015
Titles & IDs
Public title
Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease
Query!
Scientific title
DUOdopa/Duopa in Patients With Advanced Parkinson's Disease (PD) - a GLobal Observational Study Evaluating Long-Term Effectiveness (DUOGLOBE)
Query!
Secondary ID [1]
0
0
P14-494
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
DUOGLOBE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Advanced Parkinson's Disease
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Parkinson's disease
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Arm A: Participants with Advanced Parkinson's Disease - Participants who along with their physicians have elected for treatment with Duodopa/Duopa and are prescribed according to the local product label and reimbursement guidelines for their participating countries.
Arm B: Participants with Advanced Parkinson's Disease - Participants who along with their physicians have elected for treatment with Duodopa/Duopa and are prescribed according to the local product label and reimbursement guidelines for their participating countries. Participants will be evaluated with a wearable device
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change in the number of hours spent in OFF time in Arm A
Query!
Assessment method [1]
0
0
Assess the effectiveness of Duodopa/Duopa treatment on OFF time measured by the change (from baseline to 36 months) in the number of hours spent in OFF time as reported by the participant for the day prior to the clinical visit.
Query!
Timepoint [1]
0
0
Baseline visit (Enrollment) to month 36
Query!
Primary outcome [2]
0
0
Change in Duration of OFF time (hours/day) in Arm B
Query!
Assessment method [2]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 6 months) in OFF time duration as measured by UPDRS Part IV (Motor Symptoms), item 39.
Query!
Timepoint [2]
0
0
Baseline visit (Enrollment) to month 6
Query!
Primary outcome [3]
0
0
Change in Duration of OFF time (hours/day) in Arm B
Query!
Assessment method [3]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 6 months) in OFF time duration as reported by participant with PD Diary both per full 24 hours and for the time period of 09:00 - 18:00
Query!
Timepoint [3]
0
0
Baseline visit (Enrollment) to month 6
Query!
Primary outcome [4]
0
0
Duration of bradykinesia score above target in Arm B
Query!
Assessment method [4]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 6 months) in duration of bradykinesia score above target between 09:00 - 18:00 and for the full 24 hours per day (measured by Parkinson's KinetiGraph ( PKG))
Query!
Timepoint [4]
0
0
Baseline visit (Enrollment) to month 6
Query!
Primary outcome [5]
0
0
Average bradykinesia score in Arm B
Query!
Assessment method [5]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 6 months) in average bradykinesia score (measured by PKG)
Query!
Timepoint [5]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [1]
0
0
Change in Disease-Specific Caregiver Burden in Arm A
Query!
Assessment method [1]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in disease-specific caregiver burden as measured by the Modified Caregiver Strain Index (MCSI) for PD with a total score range from 0 to 26.
Query!
Timepoint [1]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [2]
0
0
Change in the Duration of Dyskinesia in Arm A
Query!
Assessment method [2]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in duration of dyskinesia as reported by the patient for the day prior to the clinical visit
Query!
Timepoint [2]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [3]
0
0
Change in Disease-Specific Sleep Quality in Arm A
Query!
Assessment method [3]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in disease-specific sleep quality as measured by Parkinson's Disease Sleep Scale-2 (PDSS-2) with a total score range from 0 to 60.
Query!
Timepoint [3]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [4]
0
0
Change in Tremor Severity in Arm A
Query!
Assessment method [4]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in tremor severity as measured by UPDRS Part III, item 20 (Tremor at Rest) with a total score range of 0 to 20.
Query!
Timepoint [4]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [5]
0
0
Change in Motor Function in Arm A
Query!
Assessment method [5]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in motor function as measured by UPDRS, Part III (Motor Examination) with a total score range of 0 to 108.
Query!
Timepoint [5]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [6]
0
0
Change in Generic Quality of Life in Arm A
Query!
Assessment method [6]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in generic quality of life as measured by EuroQoL-5 Dimensions Quality of Life Questionnaire (EQ-5D). This assessment contains a health state descriptive part with five items scored from 1 to 3.
Query!
Timepoint [6]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [7]
0
0
Change in Dyskinesia Severity in Arm A
Query!
Assessment method [7]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in dyskinesia severity as measured by Unified Dyskinesia Rating Scale (UDysRS) with a total score range from 0 to 104.
Query!
Timepoint [7]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [8]
0
0
Change in Overall Clinical Impression of Disease Severity in Arm A
Query!
Assessment method [8]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in overall clinical impression of disease severity as measured by Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD) obtained by adding four domain scores with a total score range from 0 to 24.
Query!
Timepoint [8]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [9]
0
0
Change in Disease-Specific Quality of Life in Arm A
Query!
Assessment method [9]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in disease-specific quality of life (QoL) as measured by Parkinson's Disease Questionnaire 8 (PDQ-8) summary index range from 0 to 100.
Query!
Timepoint [9]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [10]
0
0
Change in OFF Time Duration in Arm A
Query!
Assessment method [10]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in OFF time duration as measured by UPDRS Part IV (Motor Fluctuations), item 39, with a total score range of 0 to 4.
Query!
Timepoint [10]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [11]
0
0
Change in Non-Motor Symptoms in Arm A
Query!
Assessment method [11]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in non-motor symptoms as measured by Non-Motor Symptoms Scale (NMSS) with a total score range from 0 to 360.
Query!
Timepoint [11]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [12]
0
0
Change in Healthcare Resource Utilization in Arm A
Query!
Assessment method [12]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in healthcare resource utilization as measured by the Healthcare Resource Utilization Questionnaire (HCRU).
Query!
Timepoint [12]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [13]
0
0
Change in Daytime Sleepiness in Arm A
Query!
Assessment method [13]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in daytime sleepiness as measured by Epworth Sleepiness Scale (ESS) with a total score range from 0 to 24.
Query!
Timepoint [13]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [14]
0
0
Change in Activities of Daily Living in Arm A
Query!
Assessment method [14]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in Activities of Daily Living as measured by Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activity of Daily Living) with a total score range of 0 to 52.
Query!
Timepoint [14]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [15]
0
0
Change in Complications of Therapy in Arm A
Query!
Assessment method [15]
0
0
Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in Complications of Therapy (dyskinesia duration, disability, pain and early morning dystonia) as measured by UPDRS Part IV (Complications of Therapy), items 32 (individual score 0 to 4), 33 (individual score 0 to 4), 34 (individual score 0 to 4), 35 (individual score 0 to 1) and total score range of 0 to 13.
Query!
Timepoint [15]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [16]
0
0
Correlation of non-motor and motor improvements with Quality of Life improvements in Arm A
Query!
Assessment method [16]
0
0
Assess the correlation of non-motor and motor improvements with the improvement in the Quality of Life (QOL).
Query!
Timepoint [16]
0
0
Baseline visit (Enrollment) to month 36
Query!
Secondary outcome [17]
0
0
Correlation between duration of OFF time measured by UPDRS IV and duration of bradykinesia score above target in Arm B
Query!
Assessment method [17]
0
0
Assess the correlation between duration of OFF time measured by UPDRS IV item 39 and duration of bradykinesia score above target between 09:00 - 18:00 and for the full 24 hours per day measured by PKG
Query!
Timepoint [17]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [18]
0
0
Correlation between duration of OFF time measured by patient with PD Diary and average bradykinesia score in Arm B
Query!
Assessment method [18]
0
0
Assess the correlation between duration of OFF time measured by patient with PD Diary both per full 24 hours and for the time period of 09:00 - 18:00 and average bradykinesia score measured by PKG
Query!
Timepoint [18]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [19]
0
0
Correlation between duration of bradykinesia score above target and average bradykinesia score in Arm B
Query!
Assessment method [19]
0
0
Assess the correlation between duration of bradykinesia score above target between 09:00 - 18:00 and for the full 24 hours per day measured by PKG and average bradykinesia score measured by PKG
Query!
Timepoint [19]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [20]
0
0
Correlation between duration of OFF time measured by patient with PD Diary and duration of bradykinesia score above target in Arm B
Query!
Assessment method [20]
0
0
Assess the correlation between duration of OFF time measured by patient with PD Diary both per full 24 hours and for the time period of 09:00 - 18:00 and duration of bradykinesia score above target between 09:00 - 18:00 and for the full 24 hours per day measured by PKG
Query!
Timepoint [20]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [21]
0
0
Correlation between duration of OFF time measured by UPDRS IV and average bradykinesia score in Arm B
Query!
Assessment method [21]
0
0
Assess the correlation between duration of OFF time measured by UPDRS IV item 39 and average bradykinesia score measured by PKG
Query!
Timepoint [21]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [22]
0
0
Correlation between duration of dyskinesia and Unified Dyskinesia Rating Scale (UDysRS) in Arm B
Query!
Assessment method [22]
0
0
Pairwise correlation between duration of dyskinesia both per full 24 hours and 09:00 - 18:00 (based on UPDRS IV, PD diary and dyskinesia score measured by PKG) and UDysRS will be evaluated
Query!
Timepoint [22]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [23]
0
0
Severity of dyskinesia in Arm B
Query!
Assessment method [23]
0
0
Severity of dyskinesia (item 33 score of UPDRS IV, UDysRS total score or the PKG-based dyskinesia score and the pairwise correlation between these will be evaluated
Query!
Timepoint [23]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [24]
0
0
Motor symptoms in Arm B
Query!
Assessment method [24]
0
0
Motor symptoms measured by UPDRS III in ON state and correlation with PKG-based bradykinesia score will be evaluated
Query!
Timepoint [24]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [25]
0
0
Severity of tremor in Arm B
Query!
Assessment method [25]
0
0
Severity of tremor measured by item 20 of UPDRS III in ON state and PKG-based tremor score and correlation between both will be evaluated
Query!
Timepoint [25]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [26]
0
0
Activities of Daily Living (ADL) in Arm B
Query!
Assessment method [26]
0
0
ADL measured by UPDRS II in ON state and correlation with and PKG-based fluctuation/dyskinesia score and bradykinesia score will be evaluated
Query!
Timepoint [26]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [27]
0
0
Sleep in Arm B
Query!
Assessment method [27]
0
0
Sleep as measured by PDSS-2, sleep/fatigue subdomain of NMSS, duration of sleep based on PD Diary or PKG-based night-time total sleep and pairwise correlation between these will be evaluated
Query!
Timepoint [27]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [28]
0
0
Daytime sleepiness in Arm B
Query!
Assessment method [28]
0
0
Daytime sleepiness as measured by PKG-based percent of time asleep in the day time and the Epworth Sleepiness Scale and the correlation between these will be evaluated
Query!
Timepoint [28]
0
0
Baseline visit (Enrollment) to month 6
Query!
Secondary outcome [29]
0
0
Quality of Life (QoL) in Arm B
Query!
Assessment method [29]
0
0
QoL as measured by PDQ-8 and the correlation with PKG-based fluctuation/dyskinesia and bradykinesia scores will be evaluated
Query!
Timepoint [29]
0
0
Baseline visit (Enrollment) to month 6
Query!
Eligibility
Key inclusion criteria
* Eligibility for Duodopa/Duopa therapy in accordance with the approved local Duodopa/Duopa label in the participating country.
* Duodopa/Duopa naïve participants
* Decision to treat with Duodopa/Duopa made by the physician prior to any decision to approach the participant to participate in this study
* Prior to any study-related procedures being performed, the participant, or legal authorized representative (LAR) has voluntarily signed an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) according to national regulations after the study has been explained and the subject has had the opportunity to have questions answered.
* For Arm B: Participant and caregiver must be motivated to use the PKG, understand the instructions and be able to handle the device.
* For Arm B: participant must demonstrate at least 75% concordance with the investigator's or qualified designee's assessment of symptoms on the Parkinson's disease diary following training at enrollment visit 1/V1 with concordance on at least 1 time interval of "Off", concordance on at least 1 time interval of "ON regardless of dyskinesia" and at least 1 time interval of "ON with dyskinesia" irrespective of whether the dyskinesia are troublesome or not troublesome.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
99
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Any condition included in the contraindications section of the approved local Duodopa/Duopa label in the participating country.
* Participants who have had previous surgery for PD including, but not limited to deep brain stimulation (DBS) or cell transplantation (this criterion removed for US sites for Arm A).
* Participants currently in treatment with continuous apomorphine infusion. In case of a previous treatment with continuous subcutaneous apomorphine infusion, there must be at least 4 weeks between discontinuation of this treatment and inclusion into this study.
* Mini-Mental State Examination (MMSE) score <24
* Participation in a concurrent interventional clinical trial.
* Lack of motivation or insufficient language skills to complete the study questionnaires
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/01/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
24/12/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
213
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Concord Repatriation & Gen Hos /ID# 144373 - Concord
Query!
Recruitment hospital [2]
0
0
St. Vincent's Hospital, Darlinghurst /ID# 144376 - Darlinghurst
Query!
Recruitment hospital [3]
0
0
Kingston Centre /ID# 144374 - Cheltenham
Query!
Recruitment hospital [4]
0
0
Monash Medical Centre /ID# 144375 - Clayton
Query!
Recruitment postcode(s) [1]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [2]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [3]
0
0
3192 - Cheltenham
Query!
Recruitment postcode(s) [4]
0
0
3168 - Clayton
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Kansas
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kentucky
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Michigan
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Nebraska
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Pennsylvania
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Tennessee
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Vermont
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Washington
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Edegem
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Kortrijk
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
La Louviere
Query!
Country [18]
0
0
Hungary
Query!
State/province [18]
0
0
Budapest
Query!
Country [19]
0
0
Hungary
Query!
State/province [19]
0
0
Pecs
Query!
Country [20]
0
0
Israel
Query!
State/province [20]
0
0
Tel-Aviv
Query!
Country [21]
0
0
Israel
Query!
State/province [21]
0
0
Be'er Ya'akov
Query!
Country [22]
0
0
Israel
Query!
State/province [22]
0
0
Holon
Query!
Country [23]
0
0
Israel
Query!
State/province [23]
0
0
Ramat Gan
Query!
Country [24]
0
0
Italy
Query!
State/province [24]
0
0
Prato
Query!
Country [25]
0
0
Italy
Query!
State/province [25]
0
0
Rome
Query!
Country [26]
0
0
Italy
Query!
State/province [26]
0
0
Varese
Query!
Country [27]
0
0
Romania
Query!
State/province [27]
0
0
Bucuresti
Query!
Country [28]
0
0
Romania
Query!
State/province [28]
0
0
Bucharesti
Query!
Country [29]
0
0
Romania
Query!
State/province [29]
0
0
Bucharest
Query!
Country [30]
0
0
Romania
Query!
State/province [30]
0
0
Oradea, Judet Bihor
Query!
Country [31]
0
0
Romania
Query!
State/province [31]
0
0
Targu Mures
Query!
Country [32]
0
0
Romania
Query!
State/province [32]
0
0
Timisoara
Query!
Country [33]
0
0
Slovenia
Query!
State/province [33]
0
0
Ljubljana
Query!
Country [34]
0
0
Spain
Query!
State/province [34]
0
0
A Coruna
Query!
Country [35]
0
0
Spain
Query!
State/province [35]
0
0
Barcelona
Query!
Country [36]
0
0
Spain
Query!
State/province [36]
0
0
Navarra, Comunidad
Query!
Country [37]
0
0
Spain
Query!
State/province [37]
0
0
Tarragona
Query!
Country [38]
0
0
Spain
Query!
State/province [38]
0
0
Barakaldo
Query!
Country [39]
0
0
Spain
Query!
State/province [39]
0
0
Burgos
Query!
Country [40]
0
0
United Kingdom
Query!
State/province [40]
0
0
London
Query!
Country [41]
0
0
United Kingdom
Query!
State/province [41]
0
0
Romford
Query!
Country [42]
0
0
United Kingdom
Query!
State/province [42]
0
0
Salford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is a non-interventional post-marketing observational study (PMOS) of participants with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical setting. Effectiveness of treatment will be collected with physician and participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6 months thereafter up to 36 months. An additional cohort of participants will be enrolled who in addition will be evaluated with a wearable device.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02611713
Query!
Trial related presentations / publications
Aldred J, Anca-Herschkovitsch M, Antonini A, Bajenaru O, Bergmann L, Bourgeois P, Cubo E, Davis TL, Iansek R, Kovacs N, Kukreja P, Onuk K, Pontieri FE, Robieson W, Siddiqui MS, Simu M, Standaert DG, Chaudhuri KR. Application of the '5-2-1' screening criteria in advanced Parkinson's disease: interim analysis of DUOGLOBE. Neurodegener Dis Manag. 2020 Oct;10(5):309-323. doi: 10.2217/nmt-2020-0021. Epub 2020 Sep 2. Erratum In: Neurodegener Dis Manag. 2022 Feb;12(1):48-50. doi: 10.2217/nmt-2020-0021c1.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
AbbVie Inc.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
Query!
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/NCT02611713