Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing Chorea

Official Title: “A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Titration Proof of Concept Study in Patients With Huntington's Disease to Assess the Efficacy, Safety and Tolerability of AFQ056 in Reducing Chorea”

This study will assess the efficacy, safety and tolerability of AFQ056 when added to optimize standard therapy in patients that have Huntington's disease in reducing chorea.

Intervention(s) in this Clinical Trial

• Drug: AFQ056
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: AFQ056A
• Placebo Comparator: Placebo

Primary Measures

• Efficacy of AFQ056 on the severity of chorea in Huntington's disease measured by Unified Huntington's Disease Rating Scale (UHDRS) Maximal Chorea score.
  • Time Frame: Baseline to day 28
    Safety Issue?: No

Secondary Measures

• Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS.
  • Time Frame: Day 1 to day 46
    Safety Issue?: No
• Potential effect of AFQ056 on functional and quality of life scales, neuropsychiatric assessments and cognitive assessments in Huntington's Disease patients
  • Time Frame: Day 1 to day 46
    Safety Issue?: No

Inclusion Criteria:

• Huntington's disease (based on DNA testing polyQ >36) with a UHDRS maximal chorea score of >10
• patient with concomitant Huntington's medication (anti-depressants, neuroleptics, benzodiazepines) are allowed but the total daily dose and dosing regimen has to be stable for at least one months prior to randomization
• female patients without childbearing potential (post-menopausal or surgically sterilized), all patients must using a double-barrier local contraception

Exclusion Criteria:

• patients with marked cognitive impairment (MMSE less than 18), with presence of psychosis and/or confusional states
• patients with a history or presence of renal impairment and/or liver disease Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01019473

Study ID Number: CAFQ056A2207

ClinicalTrials.gov Identifier: NCT01019473

Health Authority: Germany: Federal Institute for Drugs and Medical Devices