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

Phase 2

Terminated

• Conditions: Huntington's Disease; Chorea
• Interventions: Drug: AFQ056; Drug: Placebo

• Registration Number: NCT01019473
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Primary Completion: 2011-08
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-22
• Last Update Posted: 2011-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AFQ056A	AFQ056	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Efficacy of AFQ056 on the severity of chorea in Huntington's disease measured by Unified Huntington's Disease Rating Scale (UHDRS) Maximal Chorea score.	Baseline to day 28

Secondary Outcome Measures

Name	Time	Method
Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS.	Day 1 to day 46
Potential effect of AFQ056 on functional and quality of life scales, neuropsychiatric assessments and cognitive assessments in Huntington's Disease patients	Day 1 to day 46

Trial Locations

Locations (1)

Novartis Investigator Site; 🇬🇧 Oxford, United Kingdom