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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02494778




Registration number
NCT02494778
Ethics application status
Date submitted
7/07/2015
Date registered
10/07/2015

Titles & IDs
Public title
A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease
Scientific title
A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)
Secondary ID [1] 0 0
2015-000904-24
Secondary ID [2] 0 0
TV7820-CNS-20016
Universal Trial Number (UTN)
Trial acronym
Open PRIDE-HD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pridopidine

Experimental: Pridopidine - The mode of administration is oral. Capsules will be swallowed whole with water. One capsule should be taken in the morning and 1 in the afternoon, 7 to 10 hours after the morning dose. Study drug can be taken irrespective of meals.


Treatment: Drugs: Pridopidine
45 mg BID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events
Timepoint [1] 0 0
106 weeks
Secondary outcome [1] 0 0
Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand
Timepoint [1] 0 0
Week 52; end of treatment (EOT) which was planned to occur at Week 104
Secondary outcome [2] 0 0
Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand
Timepoint [2] 0 0
Week 52; end of treatment (EOT) which was planned to occur at Week 104

Eligibility
Key inclusion criteria
* Pride HD completion within the last 6 months, including 2 week follow up period or patients who transitioned from the Open HART study or patients who complete future safety and efficacy clinical trials of pridopidine. In addition, patients who have already completed their defined study period under Open PRIDE HD global or local amendments and have discontinued treatment with pridopidine will be allowed to re enter the Open PRIDE HD study.
* Women of child bearing potential or male participants: Adequate contraception and birth control
* Good general health

* other criteria apply, please contact the investigator for more information
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Similar baseline criteria for ECG, vital signs, cardiovascular system, and renal function to PRIDE HD;
* Similar concomitant medication restrictions to PRIDE HD.

* other criteria apply, please contact the investigator for more information

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/01/2018
Sample size
Target
Accrual to date
Final
248
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 78055 - Caulfield South
Recruitment hospital [2] 0 0
Teva Investigational Site 78058 - West Perth
Recruitment hospital [3] 0 0
Teva Investigational Site 78057 - Westmead
Recruitment postcode(s) [1] 0 0
3162 - Caulfield South
Recruitment postcode(s) [2] 0 0
6005 - West Perth
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Austria
State/province [10] 0 0
Innsbruck
Country [11] 0 0
Austria
State/province [11] 0 0
Wien
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
France
State/province [13] 0 0
Angers cedex 9
Country [14] 0 0
France
State/province [14] 0 0
Creteil
Country [15] 0 0
France
State/province [15] 0 0
Lille Cedex
Country [16] 0 0
France
State/province [16] 0 0
Marseille Cedex 5
Country [17] 0 0
France
State/province [17] 0 0
Salouel
Country [18] 0 0
France
State/province [18] 0 0
Toulouse
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Bochum
Country [21] 0 0
Germany
State/province [21] 0 0
Munster
Country [22] 0 0
Germany
State/province [22] 0 0
Ulm
Country [23] 0 0
Italy
State/province [23] 0 0
Firenze
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Italy
State/province [25] 0 0
Napoli
Country [26] 0 0
Italy
State/province [26] 0 0
San Giovanni Rotondo
Country [27] 0 0
Netherlands
State/province [27] 0 0
Leiden
Country [28] 0 0
Poland
State/province [28] 0 0
Gdansk
Country [29] 0 0
Poland
State/province [29] 0 0
Krakow
Country [30] 0 0
Poland
State/province [30] 0 0
Poznan
Country [31] 0 0
Poland
State/province [31] 0 0
Warsaw
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Kazan
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Moscow
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Nyznij Novgorod
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Birmingham
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Cambridge
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Cardiff
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Manchester
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Newcastle-Upon-Tyne
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Oxford
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Prilenia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Teva Medical Expert, MD
Address 0 0
Teva Pharmaceuticals USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02494778