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Pridopidine Phase 3 Study in Huntington's Disease

RecruitingPhase 3Ages 23 Years - 65 YearsAllPrilenia
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if pridopidine can slow the clinical decline of Huntington's Disease (HD) in adult participants. It will also inform about the safety of pridopidine. The main questions the study aims to answer are: Does pridopidine slow the overall worsening of HD over 1 year? Does pridopidine slow the worsening of specific aspects of HD over 1 year, namely the clinical progression, the ability to perform daily life activities (functional capacity), the mind's ability to process information (cognition), working of the muscles (motor function), and quality of life? Researchers will compare the drug pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works better than placebo to treat HD. During the first year of the study, participants will have the same chance to receive either pridopidine or placebo. Participants

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult-onset HD (onset of signs and symptoms and a clinical diagnosis at โ‰ฅ21 years of age). * A diagnosis based on clinical features and the presence of โ‰ฅ40 CAG repeats in the huntingtin (HTT) gene confirmed by historical laboratory quanitified results or by a diagnostic test at Screening. * Diagnostic confidence level (DCL) of 4 (DCL=4 unequivocal motor signs, โ‰ฅ99% confidence) on the standardized motor exam Total Motor Score (TMS). * Total Functional Capacity (TFC) score of โ‰ฅ7 at Screening and Baseline. * Cytosine-Adenine-Guanine (CAG)-Age Product (CAP)100 score โ‰ฅ95 at Screening. * Independence Scale (IS) score โ‰ค90% at Screening. * Total Motor Score (TMS) of โ‰ฅ20 at Screening and Baseline. * Not using ADMs (VMAT2i and neuroleptics/antipsychotics) for at least 6 months prior to Screening visit. Importantly, it is not encouraged to discontinue the participants' ADM treatment solely for enrollment in the current trial. Exclusion Criteria: * Clinically significant cardiovascular disease (e.g. QTcF \>450 msec \[males\] or \>470 msec \[females\], arrhythmias, uncontrolled atrial fibrillation, or congenital long QT syndrome), seizure history โ‰ค5 years, significant neurological disorders (e.g. intracranial pathology or cerebrovascular events), active/recent malignancy (unless localized and resolved), or any serious or uncontrolled systemic disease (e.g. hepatic, renal, respiratory, endocrine, infectious \[HBV, HCV, HIV\], or psychiatric) that may pose safety risk or interfere with participation. * Severe hepatic or renal impairment. * Any mutant huntingtin (mHTT) lowering therapy in the past year. * Medications that prolong QT interval, taken within 4 weeks of the baseline visit. * Use of pridopidine within 6 weeks or 5 half-lives before the screening visit. * Previous participation in intracranial gene therapy study. * Laboratory values that fall outside of the central laboratory's reference range at Screening and are considered clinically significantly abnormal by the Investigator and affect the participant's suitability to participate in the study or put the participant at risk if he/she enters the study in the Investigator's opinion. * Female participants who are pregnant, planning to become pregnant or breastfeeding.
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What it tests

  • Pridopidine
  • Placebo
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Where

66 sites
The University of Alabama at Birmingham
Birmingham, United States
University of California, San Diego
La Jolla, United States
UCLA Medical Center
Los Angeles, United States
UC Davis Medical Center
Sacramento, United States
Georgetown University
Washington D.C., United States
University of Miami-U Health Boca Raton
Boca Raton, United States
University of Florida (Norman Fixel Institute for Neurological Diseases)
Gainesville, United States
Northwestern University
Chicago, United States

โ€ฆand 58 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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