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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Huntington's Disease; Chorea

Treatments: Drug: AFQ056; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01019473

CAFQ056A2207

2009-011743-39

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

AFQ056A

Experimental group

Treatment:

Drug: AFQ056

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo