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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT00724048
• Date of registration: 24/07/2008
• Prospective Registration: Yes
• Primary sponsor: Teva Pharmaceutical Industries
• Public title: A Study of Pridopidine (ACR16) for the Treatment of Patients With Huntington's Disease HART
• Scientific 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)
• Date of first enrolment: October 2008
• Target sample size: 227
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00724048
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Joakim Tedroff, MD
• Affiliation: NeuroSearch A/S

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Huntington Disease

Intervention(s)

Drug: ACR16 22.5 mg

Drug: ACR16 45 mg

Other: Placebo

Drug: ACR16 10 mg

Primary Outcome(s)

Sum score of items 4-10 and 13-15 of the UHDRS motor assessment [Time Frame: 26 Weeks]

Secondary Outcome(s)

Adverse event profile [Time Frame: 30 weeks]

Clinical Global Impressions (CGI) [Time Frame: At 4, 8, 12 and 26 weeks]

Secondary ID(s)

ACR16 C009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors