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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01019473
First received: November 19, 2009
Last updated: September 22, 2011
Last verified: September 2011

November 19, 2009
September 22, 2011
November 2009
August 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01019473 on ClinicalTrials.gov Archive Site
  • Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS. [ Time Frame: Day 1 to day 46 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety and tolerability of AFQ056 in Huntington's disease patients [ Time Frame: Day 1 to day 46 ] [ Designated as safety issue: Yes ]
  • Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS. [ Time Frame: Day 1 to day 46 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing Chorea
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Huntington's Disease
  • Chorea
  • Drug: AFQ056
  • Drug: Placebo
  • Experimental: AFQ056A
    Intervention: Drug: AFQ056
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
44
Not Provided
August 2011   (final data collection date for primary outcome measure)

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
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
NCT01019473
CAFQ056A2207, 2009-011743-39
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP