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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02494778
Other study ID # TV7820-CNS-20016
Secondary ID 2015-000904-24
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 24, 2015
Est. completion date January 12, 2018

Study information

Verified date August 2021
Source Prilenia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 248
Est. completion date January 12, 2018
Est. primary completion date January 12, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 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


Related Conditions & MeSH terms


Intervention

Drug:
Pridopidine
45 mg BID

Locations

Country Name City State
Australia Teva Investigational Site 78055 Caulfield South
Australia Teva Investigational Site 78058 West Perth
Australia Teva Investigational Site 78057 Westmead
Austria Teva Investigational Site 33021 Innsbruck
Austria Teva Investigational Site 33027 Wien
Canada Teva Investigational Site 11036 Toronto Ontario
France Teva Investigational Site 35123 Angers cedex 9
France Teva Investigational Site 35122 Creteil
France Teva Investigational Site 35125 Lille Cedex
France Teva Investigational Site 35124 Marseille Cedex 5
France Teva Investigational Site 35121 Salouel
France Teva Investigational Site 35165 Toulouse
Germany Teva Investigational Site 32408 Berlin
Germany Teva Investigational Site 32410 Bochum
Germany Teva Investigational Site 32409 Munster
Germany Teva Investigational Site 32407 Ulm
Italy Teva Investigational Site 30083 Firenze
Italy Teva Investigational Site 30080 Milano
Italy Teva Investigational Site 30082 Napoli
Italy Teva Investigational Site 30081 San Giovanni Rotondo
Netherlands Teva Investigational Site 38059 Leiden
Poland Teva Investigational Site 53150 Gdansk
Poland Teva Investigational Site 53149 Krakow
Poland Teva Investigational Site 53148 Poznan
Poland Teva Investigational Site 53151 Warsaw
Russian Federation Teva Investigational Site 50215 Kazan
Russian Federation Teva Investigational Site 50213 Moscow
Russian Federation Teva Investigational Site 50214 Nyznij Novgorod
United Kingdom Teva Investigational Site 34058 Birmingham
United Kingdom Teva Investigational Site 34054 Cambridge
United Kingdom Teva Investigational Site 34059 Cardiff
United Kingdom Teva Investigational Site 34055 Manchester
United Kingdom Teva Investigational Site 34061 Newcastle-Upon-Tyne
United Kingdom Teva Investigational Site 34056 Oxford
United Kingdom Teva Investigational Site 34057 Sheffield
United States Teva Investigational Site 12206 Baltimore Maryland
United States Teva Investigational Site 12201 Englewood Colorado
United States Teva Investigational Site 12204 Los Angeles California
United States Teva Investigational Site 12200 Manhasset New York
United States Teva Investigational Site 12203 New York New York
United States Teva Investigational Site 12209 Pittsburgh Pennsylvania
United States Teva Investigational Site 12210 Richmond Virginia
United States Teva Investigational Site 12198 Rochester New York
United States Teva Investigational Site 12208 Salt Lake City Utah
United States Teva Investigational Site 12196 Washington District of Columbia
United States Teva Investigational Site 12211 Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Prilenia

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Italy,  Netherlands,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Adverse Events From signature of the informed consent form through the end of the study, which was defined as Week 106 106 weeks
Secondary Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Inter-Onset-interval-SD-Hand, measured in seconds. Positive change from baseline indicates worsening. Week 52; end of treatment (EOT) which was planned to occur at Week 104
Secondary Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Peak-Force-CV-Hand, measured in %. Positive change from baseline indicates worsening. Week 52; end of treatment (EOT) which was planned to occur at Week 104
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