Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing Chorea
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| ClinicalTrials.gov Identifier: NCT01019473 |
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Recruitment Status :
Terminated
First Posted : November 25, 2009
Last Update Posted : September 23, 2011
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Huntington's Disease Chorea | Drug: AFQ056 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 44 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | November 2009 |
| Actual Primary Completion Date : | August 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Huntington's Disease
| Arm | Intervention/treatment |
|---|---|
| Experimental: AFQ056A |
Drug: AFQ056 |
| Placebo Comparator: Placebo |
Drug: Placebo |
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 ]
Secondary Outcome Measures :
- Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS. [ Time Frame: Day 1 to day 46 ]
- 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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| Ages Eligible for Study: | 30 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01019473 |
| Other Study ID Numbers: |
CAFQ056A2207 2009-011743-39 |
| First Posted: | November 25, 2009 Key Record Dates |
| Last Update Posted: | September 23, 2011 |
| Last Verified: | September 2011 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Huntington's disease Chorea Dyskinesia |
Additional relevant MeSH terms:
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Huntington Disease Chorea Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Dementia Dyskinesias |
Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Cognition Disorders Neurocognitive Disorders Mental Disorders Neurologic Manifestations |