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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04556656
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
Prilenia

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 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
Estimated Primary Completion Date : March 3, 2023
Estimated Study Completion Date : April 7, 2023

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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


Contacts
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Contact: Kristin Strazdins 1-585-242-0967 Kristin@hsglimited.org

Locations
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United States, Kansas
Prilenia Investigational Site (Site 083) Recruiting
Wichita, Kansas, United States, 67226
Contact: If you are interested in participating at this site, enter NCT 04556656 and Site 083 in subject line of email    800-487-7671    info@hsglimited.org   
Sponsors and Collaborators
Prilenia
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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 2, 2020
Last Verified: October 2020
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