Overview

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

Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Criteria
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