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

NCT ID: NCT02494778

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-24
• Study Completion Date: 2018-01-12

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).

Conditions

Huntington's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pridopidine

Intervention Type: DRUG

45 mg BID

Interventions

Pridopidine

45 mg BID

Intervention Type: DRUG

Other Intervention Names

TV7820

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prilenia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Pharmaceuticals USA

Locations

Teva Investigational Site 12204

Los Angeles, California, United States

Teva Investigational Site 12201

Englewood, Colorado, United States

Teva Investigational Site 12196

Washington D.C., District of Columbia, United States

Teva Investigational Site 12206

Baltimore, Maryland, United States

Teva Investigational Site 12200

Manhasset, New York, United States

Teva Investigational Site 12203

New York, New York, United States

Teva Investigational Site 12198

Rochester, New York, United States

Teva Investigational Site 12211

Winston-Salem, North Carolina, United States

Teva Investigational Site 12209

Pittsburgh, Pennsylvania, United States

Teva Investigational Site 12208

Salt Lake City, Utah, United States

Teva Investigational Site 12210

Richmond, Virginia, United States

Teva Investigational Site 78055

Caulfield South, , Australia

Teva Investigational Site 78058

West Perth, , Australia

Teva Investigational Site 78057

Westmead, , Australia

Teva Investigational Site 33021

Innsbruck, , Austria

Teva Investigational Site 33027

Vienna, , Austria

Teva Investigational Site 11036

Toronto, Ontario, Canada

Teva Investigational Site 35123

Angers, , France

Teva Investigational Site 35122

Créteil, , France

Teva Investigational Site 35125

Lille, , France

Teva Investigational Site 35124

Marseille, , France

Teva Investigational Site 35121

Salouël, , France

Teva Investigational Site 35165

Toulouse, , France

Teva Investigational Site 32408

Berlin, , Germany

Teva Investigational Site 32410

Bochum, , Germany

Teva Investigational Site 32409

Münster, , Germany

Teva Investigational Site 32407

Ulm, , Germany

Teva Investigational Site 30083

Florence, , Italy

Teva Investigational Site 30080

Milan, , Italy

Teva Investigational Site 30082

Napoli, , Italy

Teva Investigational Site 30081

San Giovanni Rotondo, , Italy

Teva Investigational Site 38059

Leiden, , Netherlands

Teva Investigational Site 53150

Gdansk, , Poland

Teva Investigational Site 53149

Krakow, , Poland

Teva Investigational Site 53148

Poznan, , Poland

Teva Investigational Site 53151

Warsaw, , Poland

Teva Investigational Site 50215

Kazan', , Russia

Teva Investigational Site 50213

Moscow, , Russia

Teva Investigational Site 50214

Nyznij Novgorod, , Russia

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 Kingdom

Countries

United States; Australia; Austria; Canada; France; Germany; Italy; Netherlands; Poland; Russia; United Kingdom

References

Cohen S, Waks Z, Elm JJ, Gordon MF, Grachev ID, Navon-Perry L, Fine S, Grossman I, Papapetropoulos S, Savola JM. Characterizing patient compliance over six months in remote digital trials of Parkinson's and Huntington disease. BMC Med Inform Decis Mak. 2018 Dec 20;18(1):138. doi: 10.1186/s12911-018-0714-7.

Reference Type: DERIVED

PMID: 30572891 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-000904-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TV7820-CNS-20016

Identifier Type: -

Identifier Source: org_study_id