A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease
NCT ID: NCT00665223
Last Updated: 2023-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
437 participants
INTERVENTIONAL
2008-04-24
2010-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
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.
Placebo
Capsules will be swallowed whole with water.
ACR16 45 mg
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.
ACR16
Capsules will be swallowed whole with water.
Placebo
Capsules will be swallowed whole with water.
ACR16 90 mg
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)
ACR16
Capsules will be swallowed whole with water.
Interventions
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ACR16
Capsules will be swallowed whole with water.
Placebo
Capsules will be swallowed whole with water.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
* Participants currently receiving deep brain stimulation.
* Participants 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.
30 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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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
St. Josef Hospital, Ruhr University Bochum, Gudrunstraße 56
Bochum, North Rhine-Westphalia, Germany
Westfaelische Wilhelms-Universitaet Muenster, Klinik fur Neurologie
Münster, North Rhine-Westphalia, Germany
Universitat Dresden, Klinikum Carl Gustav Carus, Fetscherstr. 74
Dresden, Saxony, Germany
Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Schumannstrasse 20/21
Berlin, , Germany
Fondazione IRCCS Istituto Nazionale Neurologico "Carlos Besta", Department of Movement Disorders, 11 via Celoria
Milan, Lombardy, Italy
IRCCS Neuromed, Localita Camarelle
Pozzilli, Molise, Italy
University Hospital of Coimbra, Av. Rissaya Barreto
Coimbra, Baixo Mondego, Portugal
Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa, Av. Prof. Egas Moniz
Lisbon, , Portugal
Hospital Mútua de Terrassa, C/ Castell
Terrassa, Catalonia, Spain
Hospital Clinic of Barcelona, Calle Villarroel, 170
Barcelona, , Spain
Hospital Ramon y Cajal, Carretera Colemenar km 9.100
Madrid, , Spain
Hospital Universitario La Fe, Avda. Campanar 21,
Valencia, , Spain
R&D Headquarters, Barberry Centre, 25 Vincent Drive
Birmingham, England/West Midlands, United Kingdom
Department of Clinical Genetics, St Mary's Hospital, Hathersage Road
Manchester, North West England, United Kingdom
First Floor Argyll House, Fosterhill, Cornhill Road
Aberdeen, Scotland, United Kingdom
SE Scotland Genetic Service, Western General Hospital, Crewe Road
Edinburgh, Scotland, United Kingdom
Churchill Hospital, Old Road, Headington
Oxford, South East England, United Kingdom
Academic Neurology Unit, E Floor Medical School Beech Hill Road
Sheffield, South Yorkshire, United Kingdom
Institute of Human Genetics, Centre for Life, Central Parkway
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Cardiff University School of Medicine, Department of Neurology & Medical Genetics, Heath Park
Cardiff, Wales, United Kingdom
Cambridge Centre for Brain repair, Cambridge University
Cambridge, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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ACR16 C008
Identifier Type: -
Identifier Source: org_study_id
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