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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02494778
Recruitment Status : Terminated (This study served its purpose in providing considerable safety data.)
First Posted : July 10, 2015
Results First Posted : September 17, 2021
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Prilenia

Study Description
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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).

Condition or disease Intervention/treatment Phase
Huntington's Disease Drug: Pridopidine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 24, 2015
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: TV7820


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494778


Locations
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Sponsors and Collaborators
Prilenia
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
  Study Documents (Full-Text)

Documents provided by Prilenia:
Study Protocol  [PDF] March 31, 2016
Statistical Analysis Plan  [PDF] January 11, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prilenia
ClinicalTrials.gov Identifier: NCT02494778    
Other Study ID Numbers: TV7820-CNS-20016
2015-000904-24 ( EudraCT Number )
First Posted: July 10, 2015    Key Record Dates
Results First Posted: September 17, 2021
Last Update Posted: September 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prilenia:
Huntington's disease, pridopidine
Additional relevant MeSH terms:
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Huntington Disease
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
Cognition Disorders
Neurocognitive Disorders
Mental Disorders