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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011743-39 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFQ056A | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFQ056 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of AFQ056 on the severity of chorea in Huntington's disease measured by Unified Huntington's Disease Rating Scale (UHDRS) Maximal Chorea score. | Baseline to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Berlin | Germany | ||||
| Novartis Investigator Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25689146 | Derived | Reilmann R, Rouzade-Dominguez ML, Saft C, Sussmuth SD, Priller J, Rosser A, Rickards H, Schols L, Pezous N, Gasparini F, Johns D, Landwehrmeyer GB, Gomez-Mancilla B. A randomized, placebo-controlled trial of AFQ056 for the treatment of chorea in Huntington's disease. Mov Disord. 2015 Mar;30(3):427-31. doi: 10.1002/mds.26174. Epub 2015 Feb 17. |
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|
| Day 1 to day 46 |
| Bochum |
| Germany |
| Novartis Investigator Site | Münster | Germany |
| Novartis Investigator Site | Taufkirchen | Germany |
| Novartis Investigator Site | Tübingen | Germany |
| Novartis Investigator Site | Ulm | Germany |
| Novartis Investigator Site | Birmingham | United Kingdom |
| Novartis Investigator Site | Cardiff | United Kingdom |
| Novartis Investigator Site | Manchester | United Kingdom |
| Novartis Investigator Site | Oxford | United Kingdom |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C581397 | mavoglurant |
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