Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing Chorea
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date
Primary Completion Date
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Ages Eligible for Study:
30 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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