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

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00665223

Collaborator

(none)

437

Enrollment

Locations

Arms

Duration (Months)

14.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Huntington's Disease	Drug: ACR16 Drug: Placebo	Phase 3

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, symptoms that seem to be most important for the functional disability associated with the disorder. To achieve this, patients are randomised to ACR16 45mg qd, ACR16 45mg bd, or placebo treatment in equal proportions in a parallel design for treatment duration of 26 weeks.

Study Design

Study Type:

Interventional

Actual Enrollment :

437 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Multicentre, Multinational, Randomized, Double-blind, Parallel-group Study Comparing ACR16 Versus Placebo for the Symptomatic Treatment of Huntington's Disease

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACR16 - once daily dose Participant received ACR16 45 mg once daily for four weeks. Weeks 5-26, ACR16 45 mg capsule and one placebo capsule were taken as two separate doses.	Drug: ACR16 45 mg capsules Capsules will be swallowed whole with water. For the first four weeks, one capsule should be taken early in the morning before food. After four weeks, one capsule should be taken early in the morning before food and one in the early afternoon at least 1 hour after food. Other Names: Pridopidine Drug: Placebo Placebo capsules. Capsules will be swallowed whole with water. For the first four weeks, one capsule should be taken early in the morning before food. After four weeks, one capsule should be taken early in the morning before food and one in the early afternoon at least 1 hour after food.
Experimental: ACR16 - twice daily dose Participant received ACR16 45 mg once daily for four weeks. Weeks 5-26, an ACR16 45 mg capsule was taken twice daily as two separate doses (total dose: 90 mg).	Drug: ACR16 45 mg capsules Capsules will be swallowed whole with water. For the first four weeks, one capsule should be taken early in the morning before food. After four weeks, one capsule should be taken early in the morning before food and one in the early afternoon at least 1 hour after food. Other Names: Pridopidine
Placebo Comparator: Placebo Participant received a placebo capsule once daily for four weeks. Weeks 5-26, a placebo capsule was taken twice daily as two separate doses.	Drug: Placebo Placebo capsules. Capsules will be swallowed whole with water. For the first four weeks, one capsule should be taken early in the morning before food. After four weeks, one capsule should be taken early in the morning before food and one in the early afternoon at least 1 hour after food.

Arm

Intervention/Treatment

Experimental: ACR16 - once daily dose

Participant received ACR16 45 mg once daily for four weeks. Weeks 5-26, ACR16 45 mg capsule and one placebo capsule were taken as two separate doses.

Drug: ACR16

45 mg capsules Capsules will be swallowed whole with water. For the first four weeks, one capsule should be taken early in the morning before food. After four weeks, one capsule should be taken early in the morning before food and one in the early afternoon at least 1 hour after food.

Other Names:

Pridopidine

Drug: Placebo

Placebo capsules. Capsules will be swallowed whole with water. For the first four weeks, one capsule should be taken early in the morning before food. After four weeks, one capsule should be taken early in the morning before food and one in the early afternoon at least 1 hour after food.

Experimental: ACR16 - twice daily dose

Participant received ACR16 45 mg once daily for four weeks. Weeks 5-26, an ACR16 45 mg capsule was taken twice daily as two separate doses (total dose: 90 mg).

Drug: ACR16

Other Names:

Pridopidine

Placebo Comparator: Placebo

Participant received a placebo capsule once daily for four weeks. Weeks 5-26, a placebo capsule was taken twice daily as two separate doses.

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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. [last timepoint at which outcome is assessed is after 26 weeks]

Secondary Outcome Measures

Safety and tolerability assessed from adverse event profile. [After 1, 4, 5, 8, 12, 26 and 30 weeks]
The effects of ACR16 on CGI, cognitive function, behaviour and symptoms of depression and anxiety. [At 4, 8, 12 and 26 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LKH -Univ. Klinikum Graz, Universitaetsklinik fur Psychiatrie Graz	Graz	Styria	Austria	8036
2	Innsbruck Medical University, Anichstraße 35	Innsbruck	Tyrol	Austria	A-6020
3	University Hospital Gasthuisberg	Leuven	Flemish Brabant	Belgium	3000
4	Hôpital Purpan, Place Docteur-Baylac, Bâtiment F	Toulouse Cedex 9	Midi-Pyrénées region	France	31059
5	CHU Roger Salengro	Lille Cedex	Nord-Pas de Calais	France	59037
6	Hôpital Nord, CHU d'Amiens, Service de Neurologie	Amiens Cedex 1	Picardie	France	80054
7	CHU La Timone, 264 Rue Saint Pierre	Marseille Cedex 05	Provence-Alpes-Cote d'Azur	France	13385
8	Universitätsklinik Ulm, Neurologie/ Oberer Eselberg 45/1	Ulm	Baden-Württemberg	Germany	89081
9	Klinikum rechts der Isar der Technischen Universität München, Neurologische Klinik und Poliklinik, Ismaninger Str. 22	München	Bavaria	Germany	81675
10	Isar Amper Klinikum gemeinnützige GmbH, Klinik Taufkirchen (Vils), Bräuhausstr.5	Taufkirchen (Vils)	Bavaria	Germany	84416
11	St. Josef Hospital, Ruhr University Bochum, Gudrunstraße 56	Bochum	North Rhine-Westphalia	Germany	44791
12	Westfaelische Wilhelms-Universitaet Muenster, Klinik fur Neurologie	Muenster	North Rhine-Westphalia	Germany	48149
13	Universitat Dresden, Klinikum Carl Gustav Carus, Fetscherstr. 74	Dresden	Saxony	Germany	01307
14	Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Schumannstrasse 20/21	Berlin		Germany	10117
15	Fondazione IRCCS Istituto Nazionale Neurologico "Carlos Besta", Department of Movement Disorders, 11 via Celoria	Milano	Lombardy	Italy	20133
16	IRCCS Neuromed, Localita Camarelle	Pozzilli	Molise	Italy	86077
17	University Hospital of Coimbra, Av. Rissaya Barreto	Coimbra	Baixo Mondego	Portugal	3000-075
18	Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa, Av. Prof. Egas Moniz	Lisboa		Portugal	1649-028
19	Hospital Mútua de Terrassa, C/ Castell	Terrassa	Catalonia	Spain	08225
20	Hospital Clinic of Barcelona, Calle Villarroel, 170	Barcelona		Spain	08036
21	Hospital Ramon y Cajal, Carretera Colemenar km 9.100	Madrid		Spain	28034
22	Hospital Universitario La Fe, Avda. Campanar 21,	Valencia		Spain	46009
23	R&D Headquarters, Barberry Centre, 25 Vincent Drive	Birmingham	England/West Midlands	United Kingdom	B15 2SG
24	Department of Clinical Genetics, St Mary's Hospital, Hathersage Road	Manchester	North West England	United Kingdom	M13 9WL
25	First Floor Argyll House, Fosterhill, Cornhill Road	Aberdeen	Scotland	United Kingdom	AB25 2ZR
26	SE Scotland Genetic Service, Western General Hospital, Crewe Road	Edinburgh	Scotland	United Kingdom	EH4 2XU
27	Churchill Hospital, Old Road, Headington	Oxford	South East England	United Kingdom	OX3 7LJ
28	Academic Neurology Unit, E Floor Medical School Beech Hill Road	Sheffield	South Yorkshire	United Kingdom	S10 2RX
29	Institute of Human Genetics, Centre for Life, Central Parkway	Newcastle on Tyne	Tyne and Wear	United Kingdom	NE1 3BZ
30	Cardiff University School of Medicine, Department of Neurology & Medical Genetics, Heath Park	Cardiff	Wales	United Kingdom	CF14 4XN
31	Cambridge Centre for Brain repair, Cambridge University	Cambridge		United Kingdom	CB2 2PY

Sponsors and Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Teva Branded Pharmaceutical Products R&D, Inc.

ClinicalTrials.gov Identifier:

NCT00665223

Other Study ID Numbers:

ACR16 C008

First Posted:

Apr 23, 2008

Last Update Posted:

Jul 21, 2016

Last Verified:

Jul 1, 2016

Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.

Huntington's Disease

Additional relevant MeSH terms:

Huntington Disease

Study Results

No Results Posted as of Jul 21, 2016