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 :
Actual Primary Completion Date :
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Ages Eligible for Study:
30 Years to 85 Years (Adult, Older Adult)
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