Trial from ClinicalTrials.gov

For full trial details, please see the original record at



Trial ID
NCT02494778
Ethics application status
Date submitted
7/07/2015
Date registered
7/07/2015
Date last updated
22/08/2017

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
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 - Study participation will continue until the drug has been authorized for marketing by the respective regulatory authorities in the USA or Europe; or the study is discontinued for medical/scientific (risk-benefit) or commercial reasons.
Timepoint [1] 0 0
364 weeks
Secondary outcome [1] 0 0
Proportion of subjects (%) who prematurely discontinued from the study
Timepoint [1] 0 0
364 weeks
Secondary outcome [2] 0 0
Proportion of subjects (%) who prematurely discontinued from the study due to AEs
Timepoint [2] 0 0
364 weeks

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
Gender
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
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
Blinded (masking 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 78056 - Kew
Recruitment hospital [2] 0 0
Teva Investigational Site 78055 - South Caulfield
Recruitment hospital [3] 0 0
Teva Investigational Site 78058 - West Perth
Recruitment hospital [4] 0 0
Teva Investigational Site 78057 - Westmead
Recruitment postcode(s) [1] 0 0
- Kew
Recruitment postcode(s) [2] 0 0
- South Caulfield
Recruitment postcode(s) [3] 0 0
- West Perth
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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United States of America
State/province [3] 0 0
District of Columbia
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United States of America
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Maryland
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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Washington
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Austria
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Innsbruck
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Austria
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Wien
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Canada
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Ontario
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Canada
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Ottawa
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Canada
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Vancouver
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Denmark
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Aarhus C
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Denmark
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Copenhagen
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France
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Angers cedex 9
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France
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Creteil
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France
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Lille Cedex
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France
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Marseille Cedex 5
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France
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Salouel
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France
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Toulouse
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Muenster
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Germany
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Ulm
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Italy
State/province [28] 0 0
Firenze
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Italy
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Milano
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Italy
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Napoli
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Italy
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San Giovanni Rotondo (FG)
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Netherlands
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Leiden
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Poland
State/province [33] 0 0
Gdansk-Zaspa
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Poland
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Krakow
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Poland
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Poznan
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Poland
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Warsaw
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Nyznij Novgorod
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United Kingdom
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Birmingham
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United Kingdom
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Cambridge
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United Kingdom
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Cardiff
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United Kingdom
State/province [43] 0 0
Headington
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United Kingdom
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Manchester
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United Kingdom
State/province [45] 0 0
Newcastle-Upon-Tyne
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Teva Branded Pharmaceutical Products, R&D Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to collect and assess long term data on the safety, tolerability,
and efficacy of pridopidine in patients with Huntington's disease (HD).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Teva Medical Expert, MD
Address 0 0
TEVA
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
Contact person responsible for updating information