A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease

Huntington's Disease Clinical Trial

— Open PRIDE-HD  

Official title:

A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)

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
• 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
• 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

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

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