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:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01306929
First received: February 28, 2011
Last updated: June 20, 2014
Last verified: June 2014

February 28, 2011
June 20, 2014
March 2011
December 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01306929 on ClinicalTrials.gov Archive Site
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
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
Not Provided
Not Provided
 
Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease
A Multi-center, North American, Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease.

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Huntington Disease
Drug: pridopidine
45mg bid
Experimental: pridopidine
45mg bid
Intervention: Drug: pridopidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
118
January 2017
December 2016   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01306929
ACR16C015
Yes
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Principal Investigator: Karl Kieburtz, MD, MPH University of Rochester
Teva Pharmaceutical Industries
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP