Clinical trial NCT00724048: A Study of Pridopidine (ACR16) for the Treatment of Participants With Huntington's Disease
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Huntington Disease
Keywords: Huntington Disease
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 227
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's Disease.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Total Motor Score (TMS)
timeFrame: Basline, Week 12
measure: Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale
timeFrame: Week 12
measure: Change From Baseline in Stroop Word Reading Test
timeFrame: Baseline, Week 12
measure: Change From Baseline in Total UHDRS Behavioral Assessment Score
timeFrame: Baseline, Week 12
measure: Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: Baseline, Week 12
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Week 14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: University of California
state: California
city: Littleton
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis Park
country: United States
facility: Struthers Parkinson's Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Manhasset
country: United States
facility: North Shore-LIJ Health System
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Parkinson's Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Kirkland
country: United States
facility: Booth Gardner Parkinson's Care Center
state: Washington
city: Edmonton
country: Canada
facility: University of Alberta Glenrose Rehab Hospital
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Markham
country: Canada
facility: The Centre for Addiction and Mental Health
state: Ontario
city: Ottawa
country: Canada
facility: Parkinsons and Neurodegenerative Disorders Clinic
state: Ontario
city: Montreal
country: Canada
facility: Hotel-Dieu Hospital-CHUM
state: Quebec
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert
role: STUDY_DIRECTOR
References: