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
  Purpose

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.


Condition Intervention Phase
Huntington's Disease
Chorea
Drug: AFQ056
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 44
Study Start Date: November 2009
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AFQ056A Drug: AFQ056
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019473

Locations
Germany
Novartis Investigator Site
Berlin, Germany
Novartis Investigator Site
Bochum, Germany
Novartis Investigator Site
Munster, Germany
Novartis Investigator Site
Taufkirchen, Germany
Novartis Investigator Site
Tubingen, Germany
Novartis Investigator Site
Ulm, Germany
United Kingdom
Novartis Investigator Site
Birmingham, United Kingdom
Novartis Investigator Site
Cardiff, United Kingdom
Novartis Investigator Site
Manchester, United Kingdom
Novartis Investigator Site
Oxford, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01019473     History of Changes
Other Study ID Numbers: CAFQ056A2207, 2009-011743-39
Study First Received: November 19, 2009
Last Updated: September 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Huntington's disease
Chorea
Dyskinesia

Additional relevant MeSH terms:
Chorea
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Dyskinesias
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014