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

NCT00665223 | Completed Phase 3 Results DMC

• 1 other identifier: ACR16 C008
• Study Type: interventional
• Target: 437
• Locations: 8 countries
• Sites: 31

Brief Summary

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

Conditions

Huntington's Disease

Keywords

Huntington's Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Modified Motor Score (mMS) (Sum of Score of Items 4-10 and 13-15 of the Unified Huntington's Disease Rating Scale [UHDRS] Motor Assessments) at Week 26

  The mMS is a subscale of the UHDRS total motor score and comprises 13 responses from the 10 items, 4-10 and 13-15, from the UHDRS motor assessment. The items for mMS include dysarthria, tongue protrusion, finger taps (right and left), pronate/supinate hands (right and left), luria - first-hand-palm sequencing, arms rigidity (right and left), body bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these items are rated on a scale of 0 (normal) to 4 (marked impairment). Total score ranges from 0 to 52, with higher scores indicating more severe motor impairment.

  Baseline, Week 26

Secondary Outcomes (7)

• The UHDRS Functional Assessment at Week 26

  Week 26

• Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score

  Week 26

• Change From Baseline in Stroop Word Reading Test at Week 26

  Baseline, Week 26

• Change From Baseline in Total UHDRS Behavioral Assessment Score at Week 26

  Baseline, Week 26

• Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) Score at Week 26

  Baseline, Week 26

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo capsule matching to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule will be taken twice daily as 2 separate doses.

Drug: Placebo

ACR16 45 mg

EXPERIMENTAL

Participants will receive ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule will be taken as 2 separate doses.

Drug: ACR16; Drug: Placebo

ACR16 90 mg

EXPERIMENTAL

Participants will receive ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule will be taken twice daily as 2 separate doses (total dose: 90 mg)

Drug: ACR16

Interventions

ACR16 DRUG

Capsules will be swallowed whole with water.

Also known as: Pridopidine

ACR16 45 mg; ACR16 90 mg

Placebo DRUG

Capsules will be swallowed whole with water.

ACR16 45 mg; Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• In France only, the participant must be affiliated to a social security system or be a beneficiary of such a system.

You may not qualify if:

• 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.
• Clinically significant hepatic or renal impairment.
• Participants 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 participant at risk when participating in the trial or may influence the results of the trial or affect the participants' ability to take part in the trial.
• Alcohol and/or drug abuse as defined by Diagnostic and Statistical Manual - Fourth Edition - Text Revision (DSM IV-TR) criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months.
• Participants 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (31)

LKH -Univ. Klinikum Graz, Universitaetsklinik fur Psychiatrie Graz

Graz, Styria, 8036, Austria

Location

Innsbruck Medical University, Anichstraße 35

Innsbruck, Tyrol, A-6020, Austria

Location

University Hospital Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

Location

CHU Roger Salengro

Lille, Hauts-de-France, 59037, France

Location

Hôpital Purpan, Place Docteur-Baylac, Bâtiment F

Toulouse, Midi-Pyrénées Region, 31059, France

Location

Hôpital Nord, CHU d'Amiens, Service de Neurologie

Amiens, Picardie, 80054, France

Location

CHU La Timone, 264 Rue Saint Pierre

Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France

Location

Universitätsklinik Ulm, Neurologie/ Oberer Eselberg 45/1

Ulm, Baden-Wurttemberg, 89081, Germany

Location

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

München, Bavaria, 81675, Germany

Location

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

Taufkirchen (Vils), Bavaria, 84416, Germany

Location

St. Josef Hospital, Ruhr University Bochum, Gudrunstraße 56

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Westfaelische Wilhelms-Universitaet Muenster, Klinik fur Neurologie

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitat Dresden, Klinikum Carl Gustav Carus, Fetscherstr. 74

Dresden, Saxony, 01307, Germany

Location

Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Schumannstrasse 20/21

Berlin, 10117, Germany

Location

Fondazione IRCCS Istituto Nazionale Neurologico "Carlos Besta", Department of Movement Disorders, 11 via Celoria

Milan, Lombardy, 20133, Italy

Location

IRCCS Neuromed, Localita Camarelle

Pozzilli, Molise, 86077, Italy

Location

University Hospital of Coimbra, Av. Rissaya Barreto

Coimbra, Baixo Mondego, 3000-075, Portugal

Location

Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa, Av. Prof. Egas Moniz

Lisbon, 1649-028, Portugal

Location

Hospital Mútua de Terrassa, C/ Castell

Terrassa, Catalonia, 08225, Spain

Location

Hospital Clinic of Barcelona, Calle Villarroel, 170

Barcelona, 08036, Spain

Location

Hospital Ramon y Cajal, Carretera Colemenar km 9.100

Madrid, 28034, Spain

Location

Hospital Universitario La Fe, Avda. Campanar 21,

Valencia, 46009, Spain

Location

R&D Headquarters, Barberry Centre, 25 Vincent Drive

Birmingham, England/West Midlands, B15 2SG, United Kingdom

Location

Department of Clinical Genetics, St Mary's Hospital, Hathersage Road

Manchester, North West England, M13 9WL, United Kingdom

Location

First Floor Argyll House, Fosterhill, Cornhill Road

Aberdeen, Scotland, AB25 2ZR, United Kingdom

Location

SE Scotland Genetic Service, Western General Hospital, Crewe Road

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Churchill Hospital, Old Road, Headington

Oxford, South East England, OX3 7LJ, United Kingdom

Location

Academic Neurology Unit, E Floor Medical School Beech Hill Road

Sheffield, South Yorkshire, S10 2RX, United Kingdom

Location

Institute of Human Genetics, Centre for Life, Central Parkway

Newcastle upon Tyne, Tyne and Wear, NE1 3BZ, United Kingdom

Location

Cardiff University School of Medicine, Department of Neurology & Medical Genetics, Heath Park

Cardiff, Wales, CF14 4XN, United Kingdom

Location

Cambridge Centre for Brain repair, Cambridge University

Cambridge, CB2 2PY, United Kingdom

Location

Related Publications (2)

• Darpo B, Geva M, Ferber G, Goldberg YP, Cruz-Herranz A, Mehra M, Kovacs R, Hayden MR. Pridopidine Does Not Significantly Prolong the QTc Interval at the Clinically Relevant Therapeutic Dose. Neurol Ther. 2023 Apr;12(2):597-617. doi: 10.1007/s40120-023-00449-w. Epub 2023 Feb 22.

  PMID: 36811812 DERIVED

• de Yebenes JG, Landwehrmeyer B, Squitieri F, Reilmann R, Rosser A, Barker RA, Saft C, Magnet MK, Sword A, Rembratt A, Tedroff J; MermaiHD study investigators. Pridopidine for the treatment of motor function in patients with Huntington's disease (MermaiHD): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011 Dec;10(12):1049-57. doi: 10.1016/S1474-4422(11)70233-2. Epub 2011 Nov 7.

  PMID: 22071279 DERIVED

MeSH Terms

Conditions

Huntington Disease

Interventions

pridopidine

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 23, 2008
• Study Start: April 24, 2008
• Primary Completion: June 14, 2010
• Study Completion: June 14, 2010
• Last Updated: August 29, 2023
• Results First Posted: August 29, 2023

Record last verified: 2023-07

Locations

BE (1); GB (9); AU (2); DE (7); FR (4); IT (2); ES (4); PT (2)