Trial record 1 of 1 for:
pridopidine
Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease (OPEN-HART)
This study is ongoing, but not recruiting participants.
Sponsor:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01306929
First received: February 28, 2011
Last updated: March 13, 2013
Last verified: March 2013
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Purpose
Huntington disease (HD) is a hereditary neurodegenerative disorder causing impairment in movement, behavioral dysfunction and dementia. The movement disorder is mainly characterized by chorea (involuntary movements) and a progressive loss of voluntary movement causing a substantial functional impairment over time. The study will assess the long-term safety of pridopidine and the treatment effects during long-term, open-label treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Huntington Disease |
Drug: pridopidine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-center, North American, Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease. |
Resource links provided by NLM:
Genetics Home Reference related topics:
chorea-acanthocytosis
Huntington disease
McLeod neuroacanthocytosis syndrome
U.S. FDA Resources
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- Number of subjects with at least one adverse event [ Time Frame: On average 2 years ] [ Designated as safety issue: No ]Long-term safety profile of pridopidine
Secondary Outcome Measures:
- Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score [ Time Frame: On average 2 years ] [ Designated as safety issue: No ]UHDRS development during long-term, open-label treatment of pridopidine
| Estimated Enrollment: | 220 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: pridopidine
45mg bid
|
Drug: pridopidine
45mg bid
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject is able to, and has provided written Informed Consent prior to any study related procedure.
- Subject has completed the HART (ACR16C009) trial, including the follow-up period, and has remained on drug during the on treatment part of the trial (including de-escalated subjects).
- Willing and able to take oral medication and able to comply with the study specific procedures.
Exclusion Criteria:
- Ongoing treatment with tetrabenazine and/or seizure threshold lowering medications.
- Newly instigated or changed treatment with neuroleptics/antipsychotics (< 6 weeks before Baseline Visit).
- Use of tricyclic antidepressants or class I antiarrhythmics within 6 weeks of Baseline Visit, or at any time during the study period.
- Any clinically significant, abnormal, laboratory result at any point during the randomized phase, including clinically significant hepatic or renal impairment, or any ongoing adverse events from the randomized phase, which in the opinion of the Investigator affects the subject's suitability for the study or puts the subject at risk if he/she enters the study.
- A prolonged QTc interval at Baseline Visit (defined as a QTc interval of >450 msec for males or > 470 msec for females), or other clinically significant heart conditions as judged by the investigator.
- Severe intercurrent illness, which, in the opinion of the Investigator, may put the subject at risk when participating in the trial.
- Alcohol and/or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis.
- Subjects 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.
- Subjects with a known history of epilepsy or a history of febrile seizure(s) or seizure(s) of unknown cause.
- Females who are pregnant or lactating.
- Females who are of child bearing potential and not taking adequate contraceptive precautions (either oral, barrier or chemical contraceptives) are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included.
- Known allergy to any ingredients of the trial medication.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306929
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| United States, California | |
| Ucsd School of Medicine | |
| San Diego, California, United States, 92161 | |
| United States, Colorado | |
| Colorado Neurological Institute Movement Disorders Center | |
| Englewood, Colorado, United States, 80113-2759 | |
| United States, Indiana | |
| Ndiana University School of Medicineoutpatient Clinical Research Facility | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa Department of Psychiatry and Neurology | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
| Johns Hopkins University Department of Psychiatry | |
| Baltimore, Maryland, United States, 21287-7281 | |
| University of Maryland School of Medicine Department of Neurology | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Charlestown, Massachusetts, United States, 02129 | |
| United States, Minnesota | |
| Struthers Parkinson'S Center | |
| Golden Valley, Minnesota, United States, 55427 | |
| United States, Missouri | |
| Washington University School of Medicine Department of Neurology | |
| St Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Parkinson'S Disease & Movement Disorders Ctr | |
| Albany, New York, United States, 12208 | |
| Northshore Long Island Jewish Northshore Institute For Medical Research | |
| Manhasset, New York, United States, 11030 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14620 | |
| University of Rochester Department of Neurology | |
| Rochester, New York, United States, 14618 | |
| United States, Ohio | |
| University of Cincinatti/Cincinatti Childrens hospital | |
| Cincinatti, Ohio, United States, 45221-0567 | |
| Ohio State University Parkinson'S Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Pennsylvania Hospital Penn Neurological Institute | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Tennessee | |
| University of Tennessee University of Tennessee Movement Disorder | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| Un of Texas Southwestern Med Ctr At Dallas | |
| Dallas, Texas, United States, 75390-9036 | |
| United States, Washington | |
| Booth Gardner Parkinson'S Care Center | |
| Kirkland, Washington, United States, 98034 | |
| Canada, Alberta | |
| University of Alberta Glenrose Rehab Hosp Movement Disorder Clinic | |
| Edmonton, Alberta, Canada, T5G 0B7 | |
| Canada, British Columbia | |
| University of British Columbiaubc Hospital Dept of Medical Genetics | |
| Vancouver, British Columbia, Canada, V6T 2B5 | |
| Canada, Ontario | |
| London Health Sciences Centreuniversity Hospital | |
| London, Ontario, Canada, N6A 5A5 | |
| Centre For Movement Disorders the Centre For Addiction and Mental Health | |
| Markham, Ontario, Canada, L6B1C9 | |
| Parkinsons &Neurodegenerative Disorder Clin | |
| Ottawa, Ontario, Canada, K1G 4G3 | |
| Canada, Quebec | |
| CHUM est NEUROLOGIE | |
| Montreal, Quebec, Canada, H2L4M1 | |
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
| Principal Investigator: | Karl Kieburtz, MD, MPH | University of Rochester |
More Information
No publications provided
| Responsible Party: | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT01306929 History of Changes |
| Other Study ID Numbers: | ACR16C015 |
| Study First Received: | February 28, 2011 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Teva Pharmaceutical Industries:
|
Huntington Disease. |
Additional relevant MeSH terms:
|
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 Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013