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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT00665223
• Date of registration: 22/04/2008
• Prospective Registration: No
• Primary sponsor: Teva Pharmaceutical Industries
• Public title: A Study of Treatment With Pridopidine (ACR16) in Patients With Huntington's Disease MermaiHD
• Scientific title: A Multicentre, Multinational, Randomized, Double-blind, Parallel-group Study Comparing ACR16 Versus Placebo for the Symptomatic Treatment of Huntington's Disease
• Date of first enrolment: April 2008
• Target sample size: 437
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00665223
• 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 3

Countries of recruitment

Austria, Belgium, France, Germany, Italy, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

- Able to provide written Informed Consent prior to any study related procedure.

- Huntington's disease diagnosed with the aid of clinical features 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 able to comply with the study specific
procedures.

- Ambulatory, being able to travel to the assessment centre, 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 patient.

- A sum of = 10 points on the mMS at the screening visit.

- For patients taking allowed antipsychotic medication, the dosing of medication must
have been kept constant for at least 6 weeks before randomisation. The allowed
antipsychotic medication is Amisulpride, Haloperidol, Olanzapine, Risperidone,
Sulpiride, or Tiapride.

- For patients taking allowed antidepressant or other psychotropic medication, the
dosing of medication must have been kept constant for at least 6 weeks before
randomisation.

- Willing to provide a blood sample for CAG analysis (where CAG result is not already
available).

- In France only, the patient must be affiliated to a social security system or be a
beneficiary of such a system.

Exclusion Criteria:

- Unable to give written informed consent.

- Treatment with any non-allowed antipsychotic medication within 12 weeks of
randomisation. The non-allowed antipsychotic medication is any medication other than
Amisulpride, Haloperidol, Olanzapine, Risperidone, Sulpiride, or Tiapride.

- Treatment with the antidepressants Fluoxetine or Paroxetine within 6 weeks of
randomisation.

- Use of Tetrabenazine within 12 weeks of randomisation, or at any time during the
study period.

- Treatment with any investigational product within 4 weeks of randomisation.

- Use of tricyclic antidepressants, class I antiarrhythmics, and strong CYP2D6
inhibitors such as Ajmalicine, Chinidin/Quinidine and Ritonavir, within 6 weeks of
randomisation.

- Patients previously included into this study.

- A prolonged QTc interval at screen (defined as a QTc interval of > 450 msec for males
or > 470 msec for females), or other clinically significant heart conditions.

- 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 patients' suitability for the study or puts the
patient at risk if he/she enters the study.

- Clinically significant hepatic or renal impairment.

- Patients with a history of epilepsy or a history of seizure(s) of unknown cause.

- Severe intercurrent illness, which, in the opinion of the Investigator, may put the
patient at risk when participating in the trial or may influence the results of the
trial or affect the patients' 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.

- Patients with suicidal ideation, 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.

- 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.

- Patients currently receiving deep brain stimulation.

- Patients with a history of surgical procedures aiming to improve the symptoms of
Huntington's disease, such as neural transplantations, lesions of the central nervous
system, infusions of neurotrophic agents or previous attempts of deep brain
stimulation.



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

Health Condition(s) or Problem(s) studied

Huntington's Disease

Intervention(s)

Drug: Placebo

Drug: ACR16

Primary Outcome(s)

The primary objective is to assess the effects of ACR16 on voluntary motor function in HD patients, as defined as the sum score of items 4-10 and 13-15 of the UHDRS motor assessment (a modified motor score mMS) at 26 weeks of treatment. [Time Frame: last timepoint at which outcome is assessed is after 26 weeks]

Secondary Outcome(s)

The effects of ACR16 on CGI, cognitive function, behaviour and symptoms of depression and anxiety. [Time Frame: At 4, 8, 12 and 26 weeks]

Safety and tolerability assessed from adverse event profile. [Time Frame: After 1, 4, 5, 8, 12, 26 and 30 weeks]

Secondary ID(s)

ACR16 C008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors