A Study of Pridopidine (ACR16) for the Treatment of Participants With Huntington's Disease
NCT ID: NCT00724048
Last Updated: 2023-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
227 participants
INTERVENTIONAL
2008-10-24
2010-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants 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.
Placebo
Placebo matching to ACR16 will be administered per schedule specified in the arm description.
ACR16 10 mg BID
Participants 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
ACR16 will be administered per dose and schedule specified in the arm description.
ACR16 22.5 mg BID
Participants 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
ACR16 will be administered per dose and schedule specified in the arm description.
ACR16 45 mg BID
Participants 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).
ACR16
ACR16 will be administered per dose and schedule specified in the arm description.
Interventions
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ACR16
ACR16 will be administered per dose and schedule specified in the arm description.
Placebo
Placebo matching to ACR16 will be administered per schedule specified in the arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Alcohol and/or drug abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV-TR) criteria for Substance Abuse - this includes the illicit use of cannabis within the last 12 months prior to Screening Visit
* Participants with suicidal ideation as defined as a positive score on criteria for major depressive episode, item A9 on the DSM -IV-TR criteria for a Major Depressive Episode
* Females who are pregnant or lactating or who intend to become pregnant during the study period.
* Females who are of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. (Females of childbearing potential taking acceptable contraceptive precautions can be included)
* Known allergy to any ingredients of the trial medication or placebo
* Any previous participation in a clinical study with ACR16.
30 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California
San Diego, California, United States
Colorado Neurological Institute
Littleton, Colorado, United States
University of South Florida
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Charlestown, Massachusetts, United States
Struthers Parkinson's Center
Saint Louis Park, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Albany Medical College
Albany, New York, United States
North Shore-LIJ Health System
Manhasset, New York, United States
University of Rochester
Rochester, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Ohio State University Parkinson's Center
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Booth Gardner Parkinson's Care Center
Kirkland, Washington, United States
University of Alberta Glenrose Rehab Hospital
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
The Centre for Addiction and Mental Health
Markham, Ontario, Canada
Parkinsons and Neurodegenerative Disorders Clinic
Ottawa, Ontario, Canada
Hotel-Dieu Hospital-CHUM
Montreal, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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ACR16 C009
Identifier Type: -
Identifier Source: org_study_id
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