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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002073-30 | EudraCT Number |
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This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFQ056 100 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFQ056 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) | 12 weeks | |
| Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Sunnyvale | California | 94089 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27214258 | Derived | Trenkwalder C, Stocchi F, Poewe W, Dronamraju N, Kenney C, Shah A, von Raison F, Graf A. Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies. Mov Disord. 2016 Jul;31(7):1054-8. doi: 10.1002/mds.26585. Epub 2016 May 23. |
| Label | URL |
|---|---|
| Results for CAFQ056A2222 from the Novartis Clinical Trials website | View source |
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|
| 12 weeks |
| Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary) | 12 weeks |
| Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS ) | 12 weeks |
| Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events | 12 weeks |
| Englewood |
| Colorado |
| 80113 |
| United States |
| Novartis Investigative Site | London | Ontario | N6A 4G5 | Canada |
| Novartis Investigative Site | Gatineau | Quebec | J9J 0A5 | Canada |
| Novartis Investigative Site | Clermont-Ferrand | 63003 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Pessac | 33604 | France |
| Novartis Investigative Site | Poitiers | 86021 | France |
| Novartis Investigative Site | Beelitz-Heilstätten | 14547 | Germany |
| Novartis Investigative Site | Berlin | 12163 | Germany |
| Novartis Investigative Site | Bochum | 44791 | Germany |
| Novartis Investigative Site | Düsseldorf | 40225 | Germany |
| Novartis Investigative Site | Kassel | 34128 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | München | 80804 | Germany |
| Novartis Investigative Site | München | 81675 | Germany |
| Novartis Investigative Site | Stadtroda | 07646 | Germany |
| Novartis Investigative Site | Westerstede/Oldenburg | 26655 | Germany |
| Novartis Investigative Site | Budapest | 1085 | Hungary |
| Novartis Investigative Site | Kaposvár | 7400 | Hungary |
| Novartis Investigative Site | Szeged | H-6725 | Hungary |
| Novartis Investigative Site | Bolzano | BZ | 39100 | Italy |
| Novartis Investigative Site | Pisa | PI | 56126 | Italy |
| Novartis Investigative Site | Roma | RM | 00163 | Italy |
| Novartis Investigative Site | Sant Cugat del Vallès | Barcelona | 08190 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | Donostia / San Sebastian | 20014 | Spain |
| Novartis Investigative Site | Madrid | 28006 | Spain |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D010300 | Parkinson Disease |
| D009069 | Movement Disorders |
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C581397 | mavoglurant |
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