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
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
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 March 03, 2015