A Study of Pridopidine (ACR16) for the Treatment of Patients With Huntington's Disease

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries

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 subject to two visits.

• A sum of ≥ 10 points on the mMS at the screening visit.

• For subjects taking allowed antidepressants or other psychotropic medication , the dosing of medication must have been kept constant for at least 6 weeks before enrollment.

Exclusion Criteria:

• Treatment with any antipsychotic medication (neuroleptics) within 8 weeks of enrollment, or at any time point during the study period.

• Use of tetrabenazine within 12 weeks of enrollment, or at any time during the study period.

• Treatment with any investigational product within 4 weeks of enrollment.

• Use of tricyclic antidepressants or class I antiarrhythmics within 6 weeks of enrollment, or at any time during the study period.

• Use of concomitant medication that may lower the seizure threshold within 6 weeks of enrollment, or at any time during the study period .

• Use of metoclopramide within 12 weeks of enrollment, or at any time during the study period.

• Subjects currently receiving deep brain stimulation (DBS).

• Subjects 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.

• Subjects previously randomized into this study.

• A prolonged QTc interval at Screening 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.

• Creatinine clearance <40mL/min as measured at the screening visit.

• Any clinically significant, abnormal, baseline laboratory result which in the opinion of the Investigator, affects the subjects' suitability for the study or puts the subject at risk if he/she enters the study.

• Clinically significant hepatic or renal impairment.

• Subjects 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 subject 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 DSM IV-TR criteria for Substance Abuse - this includes the illicit use of cannabis within the last 12 months prior to Screening Visit

• 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

• 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 child bearing 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.