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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01019473 |
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Date of registration:
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19/11/2009 |
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Primary sponsor: |
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Public title:
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Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing Chorea
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Scientific title:
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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 |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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44 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01019473 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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United Kingdom
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chorea
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Huntington's Disease
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Intervention(s)
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Drug: AFQ056
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Drug: Placebo
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Primary Outcome(s)
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Efficacy of AFQ056 on the severity of chorea in Huntington's disease measured by Unified Huntington's Disease Rating Scale (UHDRS) Maximal Chorea score.
[Time Frame: Baseline to day 28]
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Secondary Outcome(s)
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Potential effect of AFQ056 on functional and quality of life scales, neuropsychiatric assessments and cognitive assessments in Huntington's Disease patients
[Time Frame: Day 1 to day 46]
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Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS.
[Time Frame: Day 1 to day 46]
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Secondary ID(s)
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2009-011743-39
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CAFQ056A2207
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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