A Study of Pridopidine (ACR16) for the Treatment of Participants With Huntington's Disease
HART
A Multi-center, North American, Randomized, Double-blind, Parallel Group Study Comparing Three Doses of ACR16 Versus Placebo for the Symptomatic Treatment of Huntington Disease (HART)
1 other identifier
interventional
227
2 countries
28
Brief Summary
The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2008
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2008
CompletedFirst Posted
Study publicly available on registry
July 29, 2008
CompletedStudy Start
First participant enrolled
October 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2010
CompletedResults Posted
Study results publicly available
August 31, 2023
CompletedAugust 31, 2023
July 1, 2023
1.8 years
July 24, 2008
June 23, 2023
August 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Modified Motor Score (mMS) (Sum of Score of Items 4-10 and 13-15 of the UHDRS Motor Assessments) at Week 12
The mMS is a subscale of the UHDRS total motor score and comprises 13 responses from the 10 items, 4-10 and 13-15, from the UHDRS motor assessment. The items for mMS included dysarthria, tongue protrusion, finger taps (right and left), pronate/supinate hands (right and left), luria - first-hand-palm sequencing, arms rigidity (right and left), body bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these items were rated on a scale of 0 (normal) to 4 (marked impairment). Total score ranged from 0 to 52, with higher scores indicating more severe motor impairment. The last observation carried forward (LOCF) method was used to generate an mMS score for each participant for Week 12 assessment.
Baseline, Week 12
Secondary Outcomes (6)
Change From Baseline in Total Motor Score (TMS)
Basline, Week 12
Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale
Week 12
Change From Baseline in Stroop Word Reading Test
Baseline, Week 12
Change From Baseline in Total UHDRS Behavioral Assessment Score
Baseline, Week 12
Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) Score
Baseline, Week 12
- +1 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants will receive a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule will be taken twice daily (BID) as 2 separate doses.
ACR16 10 mg BID
EXPERIMENTALParticipants will receive ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule will be taken twice daily (BID) as 2 separate doses (total dose: 20 mg).
ACR16 22.5 mg BID
EXPERIMENTALParticipants will receive ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule will be taken twice daily (BID) as 2 separate doses (total dose: 45 mg).
ACR16 45 mg BID
EXPERIMENTALParticipants will receive ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule will be taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Interventions
Eligibility Criteria
You may qualify if:
- Able to provide written Informed Consent prior to any study related procedure, including consent to genotyping of the CYP2D6 gene.
- Clinical features of HD, and a positive family history and/or the presence of ≥ 36 CAG repeats in the Huntington gene.
- Male or female age ≥ 30 years.
- Willing and able to take oral medication and to comply with the study specific procedures.
- Ambulatory, being able to travel to the assessment center, and judged by the Investigator as likely to be able to continue to travel for the duration of the study.
- Availability of a caregiver or family member to accompany the participant to two visits.
- A sum of ≥ 10 points on the mMS at the screening visit.
- For participants taking allowed antidepressants or other psychotropic medication , the dosing of medication must have been kept constant for at least 6 weeks before baseline visit.
You may not qualify if:
- Treatment with any antipsychotic medication (neuroleptics) within 8 weeks of baseline visit, or at any time point during the study period.
- Use of tetrabenazine within 12 weeks of baseline visit, or at any time during the study period.
- Treatment with any investigational product within 4 weeks of baseline visit.
- Use of tricyclic antidepressants or class I antiarrhythmics within 6 weeks of baseline visit, or at any time during the study period.
- Use of concomitant medication that may lower the seizure threshold within 6 weeks of baseline visit, or at any time during the study period .
- Use of metoclopramide within 12 weeks of baseline visit, or at any time during the study period.
- Participants currently receiving deep brain stimulation (DBS).
- Participants with a history of surgical procedures aiming to improve the symptoms of Huntington disease, such as neural transplantations, lesions of the central nervous system, infusions of neurotrophic agents or previous attempts of deep brain stimulation.
- Participants previously randomized into this study.
- A prolonged QTc interval at Screening Visit (defined as a QTc interval of \> 450 milliseconds \[msec\] for males or \> 470 msec for females), or other clinically significant heart conditions as judged by the investigator.
- Creatinine clearance \<40 milliliters (mL)/minute (min) as measured at the screening visit.
- Any clinically significant, abnormal, baseline laboratory result which in the opinion of the Investigator, affects the participant' suitability for the study or puts the participant at risk if he/she enters the study.
- Clinically significant hepatic or renal impairment.
- Participants with a known history of epilepsy or a history of febrile seizure(s) or seizure(s) of unknown cause.
- Severe intercurrent illness, which, in the opinion of the Investigator, may put the participant at risk when participating in the trial or may influence the results of the trial or affect the subjects' ability to take part in the trial.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of California
San Diego, California, 92161, United States
Colorado Neurological Institute
Littleton, Colorado, 80120, United States
University of South Florida
Tampa, Florida, 33612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21287-7281, United States
Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
Struthers Parkinson's Center
Saint Louis Park, Minnesota, 55426, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Albany Medical College
Albany, New York, 12208, United States
North Shore-LIJ Health System
Manhasset, New York, 11030, United States
University of Rochester
Rochester, New York, 14618, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Ohio State University Parkinson's Center
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9036, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034, United States
University of Alberta Glenrose Rehab Hospital
Edmonton, Alberta, T5G 0B7, Canada
University of British Columbia
Vancouver, British Columbia, V6T 2B5, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
The Centre for Addiction and Mental Health
Markham, Ontario, L6B1C9, Canada
Parkinsons and Neurodegenerative Disorders Clinic
Ottawa, Ontario, K1G4G3, Canada
Hotel-Dieu Hospital-CHUM
Montreal, Quebec, H2L4M1, Canada
Related Publications (1)
Darpo B, Geva M, Ferber G, Goldberg YP, Cruz-Herranz A, Mehra M, Kovacs R, Hayden MR. Pridopidine Does Not Significantly Prolong the QTc Interval at the Clinically Relevant Therapeutic Dose. Neurol Ther. 2023 Apr;12(2):597-617. doi: 10.1007/s40120-023-00449-w. Epub 2023 Feb 22.
PMID: 36811812DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products R&D, Inc.
Study Officials
- STUDY DIRECTOR
Teva Medical Expert
Teva Branded Pharmaceutical Products R&D, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2008
First Posted
July 29, 2008
Study Start
October 24, 2008
Primary Completion
July 26, 2010
Study Completion
July 26, 2010
Last Updated
August 31, 2023
Results First Posted
August 31, 2023
Record last verified: 2023-07