A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008)

• Register: EUCTR
• Last refreshed on: 18 September 2012
• Main ID: EUCTR2007-004988-22-GB
• Date of registration: 16/10/2007
• Prospective Registration: Yes
• Primary sponsor: NeuroSearch Sweden AB
• Public title: A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008)
• Scientific title: A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008)
• Date of first enrolment: 11/01/2008
• Target sample size: 420
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004988-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

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 to Visit 1 and Visit 7.

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 Visit 1 (Randomisation visit). 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 Visit 1 (Randomisation visit).

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Unable to give written informed consent.

Treatment with any non-allowed antipsychotic medication within 12 weeks of Visit 1 (Randomisation visit). 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 Visit 1 (Randomisation visit).

Use of Tetrabenazine within 12 weeks of Visit 1 (Randomisation visit), or at any time during the study period.

Treatment with any investigational product within 4 weeks of Visit 1 (Randomisation visit).

Use of tricyclic antidepressants, class I antiarrhythmics, and strong CYP2D6 inhibitors such as Ajmalicine, Chinidin/Quinidine and Ritonavir, within 6 weeks of Visit 1 (Randomisation visit).

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 (Please refer to Investigator Brochure for a full ingredient list).

Any previous participation in a clinical study with ACR16.

Patients currently receiving deep brain stimulation (DBS).

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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Huntington's Disease
MedDRA version: 9.1 Level: LLT Classification code 10020469 Term: Huntington's chorea

Intervention(s)

Product Name: ACR16
Product Code: ACR16
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ACR16
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Secondary objectives are to assess the effects of ACR16 on Clinical Global Impression(CGI) , cognitive function, behaviour and symptoms of depression and anxiety at 26 weeks of treatment and to assess the safety and tolerability of ACR16.

Main Objective: To assess the effects of ACR16 on voluntary movement function in HD patients, 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.

Primary end point(s): The primary variable is the change in mMS (items 4-10 and 13-15 of the UHDRS [Unified Huntington's Disease Rating Scale] motor assessment) from baseline to the week 26 assessment.

Secondary ID(s)

ACR16 C008