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PRidopidine's Outcome On Function in Huntington Disease, PROOF- 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: NCT04556656
Recruitment Status : Active, not recruiting
First Posted : September 21, 2020
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
Prilenia

Study Description
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Brief Summary:
This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: Pridopidine Drug: Placebo Phase 3

Detailed Description:

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pridopidine 45 mg BID in patients with early stage HD.

Eligible patients who completed the Main Study (65 to 78 weeks) will have the option to enroll into an open-label extension.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 499 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients With Early Stage of Huntington Disease
Actual Study Start Date : October 16, 2020
Actual Primary Completion Date : March 14, 2023
Estimated Study Completion Date : March 14, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pridopidine
45 mg pridopidine twice daily (BID)
 Drug: Pridopidine
Pridopidine hard gelatin capsule
Placebo Comparator: Placebo
Matching placebo
 Drug: Placebo
Pridopidine-matching placebo hard gelatin capsule


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in the Unified Huntington Disease Rating Scale-Total functional capacity (UHDRS-TFC) score [ Time Frame: Baseline, 65 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA MAIN STUDY

  1. Diagnosis of HD based on clinical features and the presence of ≥36 CAG repeats in the huntingtin gene
  2. Diagnostic confidence level (DCL) of 4
  3. Adult-onset HD with onset of signs and symptoms ≥18 years of age
  4. Stage 1 or Stage 2 HD, defined as a UHDRS-TFC score of ≥7, at screening

EXCLUSION CRITERIA

  1. Use of pridopidine within 12 months before the baseline visit.
  2. Gene therapy at any time
  3. Any serious medical condition or clinically significant laboratory, or vital sign abnormality that precludes the patient's safe participation in and completion of the study e.g. significant heart disease within 12 weeks before baseline or history of certain cardiac arrhythmias
  4. History of epilepsy or seizures within the last 5 years
  5. Pregnant or breastfeeding, or intention to become pregnant during the study
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): NCT04556656


Locations
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Sponsors and Collaborators
Prilenia
More Information
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Responsible Party: Prilenia
ClinicalTrials.gov Identifier: NCT04556656    
Other Study ID Numbers: PL101-HD301
2020-002822-10 ( EudraCT Number )
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
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 Disease
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