Trial record 1 of 775 for:
Huntington's Disease
Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing Chorea
This study has been terminated.
Sponsor:
Novartis Pharmaceuticals
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
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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:
Genetics Home Reference related topics:
chorea-acanthocytosis
Huntington disease
McLeod neuroacanthocytosis syndrome
MedlinePlus related topics:
Huntington's Disease
U.S. FDA Resources
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
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:
|
Huntington Disease Movement Disorders Central Nervous System Diseases Nervous System Diseases Basal Ganglia Diseases Brain Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn |
Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Chorea Dyskinesias Neurologic Manifestations Signs and Symptoms Dementia |
ClinicalTrials.gov processed this record on May 16, 2013