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

NCT02494778 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: TV7820-CNS-200162015-000904-24
• Study Type: interventional
• Target: 248
• Locations: 10 countries
• Sites: 44

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

Keywords

Huntington's disease, pridopidine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand

  Week 52; end of treatment (EOT) which was planned to occur at Week 104

• Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand

  Week 52; end of treatment (EOT) which was planned to occur at Week 104

Study Arms (1)

Pridopidine

EXPERIMENTAL

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.

Drug: Pridopidine

Interventions

Pridopidine DRUG

45 mg BID

Also known as: TV7820

Pridopidine

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prilenia: lead

Study Sites (46)

Teva Investigational Site 12204

Los Angeles, California, 90095, United States

Location

Teva Investigational Site 12201

Englewood, Colorado, 80113, United States

Location

Teva Investigational Site 12196

Washington D.C., District of Columbia, 20007, United States

Location

Teva Investigational Site 12206

Baltimore, Maryland, 21287, United States

Location

Teva Investigational Site 12200

Manhasset, New York, 11030, United States

Location

Teva Investigational Site 12203

New York, New York, 10032, United States

Location

Teva Investigational Site 12198

Rochester, New York, 14618, United States

Location

Teva Investigational Site 12211

Winston-Salem, North Carolina, 27157, United States

Location

Teva Investigational Site 12209

Pittsburgh, Pennsylvania, 15213, United States

Location

Teva Investigational Site 12208

Salt Lake City, Utah, 84108, United States

Location

Teva Investigational Site 12210

Richmond, Virginia, 23230, United States

Location

Teva Investigational Site 78055

Caulfield South, 3162, Australia

Location

Teva Investigational Site 78058

West Perth, 6005, Australia

Location

Teva Investigational Site 78057

Westmead, 2145, Australia

Location

Teva Investigational Site 33021

Innsbruck, A-6020, Austria

Location

Teva Investigational Site 33027

Vienna, 1010, Austria

Location

Teva Investigational Site 11036

Toronto, Ontario, M3B 2S7, Canada

Location

Teva Investigational Site 35123

Angers, 49933, France

Location

Teva Investigational Site 35122

Créteil, 94010, France

Location

Teva Investigational Site 35125

Lille, 59037, France

Location

Teva Investigational Site 35124

Marseille, 13385, France

Location

Teva Investigational Site 35121

Salouël, 80054, France

Location

Teva Investigational Site 35165

Toulouse, 31059, France

Location

Teva Investigational Site 32408

Berlin, 10117, Germany

Location

Teva Investigational Site 32410

Bochum, 44791, Germany

Location

Teva Investigational Site 32409

Münster, 48149, Germany

Location

Teva Investigational Site 32407

Ulm, 89081, Germany

Location

Teva Investigational Site 30083

Florence, 50134, Italy

Location

Teva Investigational Site 30080

Milan, 20133, Italy

Location

Teva Investigational Site 30082

Napoli, 80131, Italy

Location

Teva Investigational Site 30081

San Giovanni Rotondo, 71013, Italy

Location

Teva Investigational Site 38059

Leiden, 2333 ZA, Netherlands

Location

Teva Investigational Site 53150

Gdansk, 80-462, Poland

Location

Teva Investigational Site 53149

Krakow, 31-505, Poland

Location

Teva Investigational Site 53148

Poznan, 60-529, Poland

Location

Teva Investigational Site 53151

Warsaw, 02-957, Poland

Location

Teva Investigational Site 50215

Kazan', 420101, Russia

Location

Teva Investigational Site 50213

Moscow, 125367, Russia

Location

Teva Investigational Site 50214

Nyznij Novgorod, 603126, Russia

Location

Teva Investigational Site 34058

Birmingham, B15 2SG, United Kingdom

Location

Teva Investigational Site 34054

Cambridge, CB2 2PY, United Kingdom

Location

Teva Investigational Site 34059

Cardiff, CF14 4XN, United Kingdom

Location

Teva Investigational Site 34055

Manchester, M13 9WL, United Kingdom

Location

Teva Investigational Site 34061

Newcastle upon Tyne, NE6 4QD, United Kingdom

Location

Teva Investigational Site 34056

Oxford, OX3 9DU, United Kingdom

Location

Teva Investigational Site 34057

Sheffield, S10 2JF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30572891 DERIVED

MeSH Terms

Conditions

Huntington Disease

Interventions

pridopidine

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

This was an open-label extension of study TV7820-CNS-20002. It was terminated on 10 Nov 2017, as it was considered by the sponsor to have served its purpose in providing long-term safety data. Study termination was not based on safety concerns.

Results Point of Contact

• Title: Prilenia
• Organization: Prilenia

info@prilenia.com

+972 775558

Study Officials

• Teva Medical Expert, MD

  Teva Pharmaceuticals USA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 10, 2015
• Study Start: September 24, 2015
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: September 17, 2021
• Results First Posted: September 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); GB (7); FR (6); DE (4); US (11); NL (1); PL (4); RU (3); CA (1); IT (4)