A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease (Open PRIDE-HD)

August 23, 2021 updated by: Prilenia

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Caulfield South, Australia, 3162
        • Teva Investigational Site 78055
      • West Perth, Australia, 6005
        • Teva Investigational Site 78058
      • Westmead, Australia, 2145
        • Teva Investigational Site 78057
  • Austria
      • Innsbruck, Austria, A-6020
        • Teva Investigational Site 33021
      • Wien, Austria, 1010
        • Teva Investigational Site 33027
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3B 2S7
        • Teva Investigational Site 11036
  • France
      • Angers cedex 9, France, 49933
        • Teva Investigational Site 35123
      • Creteil, France, 94010
        • Teva Investigational Site 35122
      • Lille Cedex, France, 59037
        • Teva Investigational Site 35125
      • Marseille Cedex 5, France, 13385
        • Teva Investigational Site 35124
      • Salouel, France, 80054
        • Teva Investigational Site 35121
      • Toulouse, France, 31059
        • Teva Investigational Site 35165
  • Germany
      • Berlin, Germany, 10117
        • Teva Investigational Site 32408
      • Bochum, Germany, 44791
        • Teva Investigational Site 32410
      • Munster, Germany, 48149
        • Teva Investigational Site 32409
      • Ulm, Germany, 89081
        • Teva Investigational Site 32407
  • Italy
      • Firenze, Italy, 50134
        • Teva Investigational Site 30083
      • Milano, Italy, 20133
        • Teva Investigational Site 30080
      • Napoli, Italy, 80131
        • Teva Investigational Site 30082
      • San Giovanni Rotondo, Italy, 71013
        • Teva Investigational Site 30081
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Teva Investigational Site 38059
  • Poland
      • Gdansk, Poland, 80-462
        • Teva Investigational Site 53150
      • Krakow, Poland, 31-505
        • Teva Investigational Site 53149
      • Poznan, Poland, 60-529
        • Teva Investigational Site 53148
      • Warsaw, Poland, 02-957
        • Teva Investigational Site 53151
  • Russian Federation
      • Kazan, Russian Federation, 420101
        • Teva Investigational Site 50215
      • Moscow, Russian Federation, 125367
        • Teva Investigational Site 50213
      • Nyznij Novgorod, Russian Federation, 603126
        • Teva Investigational Site 50214
  • United Kingdom
      • Birmingham, United Kingdom, B15 2SG
        • Teva Investigational Site 34058
      • Cambridge, United Kingdom, CB2 2PY
        • Teva Investigational Site 34054
      • Cardiff, United Kingdom, CF14 4XN
        • Teva Investigational Site 34059
      • Manchester, United Kingdom, M13 9WL
        • Teva Investigational Site 34055
      • Newcastle-Upon-Tyne, United Kingdom, NE6 4QD
        • Teva Investigational Site 34061
      • Oxford, United Kingdom, OX3 9DU
        • Teva Investigational Site 34056
      • Sheffield, United Kingdom, S10 2JF
        • Teva Investigational Site 34057
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Teva Investigational Site 12204
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Teva Investigational Site 12201
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Teva Investigational Site 12196
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Teva Investigational Site 12206
    • New York
      • Manhasset, New York, United States, 11030
        • Teva Investigational Site 12200
      • New York, New York, United States, 10032
        • Teva Investigational Site 12203
      • Rochester, New York, United States, 14618
        • Teva Investigational Site 12198
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Teva Investigational Site 12211
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Teva Investigational Site 12209
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Teva Investigational Site 12208
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Teva Investigational Site 12210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Pridopidine
45 mg BID
Other Names:
  • TV7820

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events
Time Frame: 106 weeks
From signature of the informed consent form through the end of the study, which was defined as Week 106
106 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand
Time Frame: Week 52; end of treatment (EOT) which was planned to occur at Week 104
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
Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand
Time Frame: Week 52; end of treatment (EOT) which was planned to occur at Week 104
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prilenia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2015

Primary Completion (Actual)

January 12, 2018

Study Completion (Actual)

January 12, 2018

Study Registration Dates

First Submitted

July 7, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (Estimate)

July 10, 2015

Study Record Updates

Last Update Posted (Actual)

September 17, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TV7820-CNS-20016
  • 2015-000904-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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