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A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Multicentre, Multinational, Randomised, Double-Blind, Parallel-Group Study Comparing ACR16 45 mg Once-Daily or Twice-Daily Versus Placebo for the Symptomatic Treatment of Huntington's Disease

NCT00665223•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

The primary objective in the present study is to confirm whether ACR16 is efficacious in improving voluntary motor function in Huntington's disease based on the Unified Huntington"s Disease Rating Scale (UHDRS) subscale. These symptoms seem to be most important for the functional disability associated with the disorder. To achieve this, participants are randomized to ACR16 45 mg once daily, ACR16 45 mg twice daily, or placebo treatment in equal proportions in a parallel design for a treatment duration of 26 weeks.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

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 participant.
•A sum of ≥ 10 points on the mMS at the screening visit.
•For participants taking allowed antipsychotic medication, the dosing of medication must have been kept constant for at least 6 weeks before randomization. The allowed antipsychotic medication is Amisulpride, Haloperidol, Olanzapine, Risperidone, Sulpiride, or Tiapride.
•For participants taking allowed antidepressant or other psychotropic medication, the dosing of medication must have been kept constant for at least 6 weeks before randomization.
•Willing to provide a blood sample for CAG analysis (where CAG result is not already available).
+1 more criteria

Exclusion Criteria

•Unable to give written informed consent.
•Treatment with any non-allowed antipsychotic medication within 12 weeks of randomization. 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 randomization.
•Use of Tetrabenazine within 12 weeks of randomization, or at any time during the study period.
•Treatment with any investigational product within 4 weeks of randomization.
•Use of tricyclic antidepressants, class I antiarrhythmics, and strong CYP2D6 inhibitors such as Ajmalicine, Chinidin/Quinidine and Ritonavir, within 6 weeks of randomization.
•Participants previously included into this study.
•A prolonged QTc interval at screen (defined as a QTc interval of \> 450 milliseconds \[msec\] for males or \> 470 msec for females), or other clinically significant heart conditions.
•Creatinine clearance \<40 milliliters (mL)/minute (min) as measured at the screening visit.
•Any clinically significant, abnormal, baseline laboratory result which in the opinion of the Investigator, affects the participants' suitability for the study or puts the participant at risk if he/she enters the study.
+11 more criteria

Locations (31)

LKH -Univ. Klinikum Graz, Universitaetsklinik fur Psychiatrie Graz

Graz, Styria, Austria

Innsbruck Medical University, Anichstraße 35

Innsbruck, Tyrol, Austria

University Hospital Gasthuisberg

Leuven, Flemish Brabant, Belgium

CHU Roger Salengro

Lille, Hauts-de-France, France

Hôpital Purpan, Place Docteur-Baylac, Bâtiment F

Toulouse, Midi-Pyrénées Region, France

Hôpital Nord, CHU d'Amiens, Service de Neurologie

Amiens, Picardie, France

CHU La Timone, 264 Rue Saint Pierre

Marseille, Provence-Alpes-Côte d'Azur Region, France

Universitätsklinik Ulm, Neurologie/ Oberer Eselberg 45/1

Ulm, Baden-Wurttemberg, Germany

Klinikum rechts der Isar der Technischen Universität München, Neurologische Klinik und Poliklinik, Ismaninger Str. 22

München, Bavaria, Germany

Isar Amper Klinikum gemeinnützige GmbH, Klinik Taufkirchen (Vils), Bräuhausstr.5

Taufkirchen (Vils), Bavaria, Germany

Key Dates

Start Date

April 24, 2008

Primary Completion Date

June 14, 2010

Completion Date

June 14, 2010

Last Updated

August 29, 2023

Enrollment

437

ACTUAL participants

Conditions

Huntington's Disease

Interventions

ACR16

DRUG

Placebo

DRUG

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

NCT02855476

Huntington's Disease

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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease

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Huntington's Disease

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A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease

A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)

Study to Measure Cerebrospinal Fluid Mutant Huntingtin Protein in Participants With Early Manifest Stage I or Stage II Huntington's Disease

Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease

A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease