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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019418-25 | EudraCT Number |
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The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFQ056 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFQ056 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs/SAEs, changes in vital signs, lab assessments and ECGs, in cognitive function (MMSE), psychiatric symptoms (SCOPA-PC), and underlying symptoms of PD (UPDRS part III, CGIC, PGIC). | 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of dyskinetic symptoms by change from baseline in mAIMS total score | 3.5 years | |
| Investigator and patient assessment of clinical changes in dyskinetic symptoms and disability due to dyskinesia compared to baseline, as measured by the corresponding CGIC and PGIC items respectively |
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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 |
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| Label | URL |
|---|---|
| Results for CAFQ056A2217 from the Novartis Clinical Trials Website | View source |
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| 3.5 years |
| Englewood |
| Colorado |
| 80113 |
| United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46202 | United States |
| Novartis Investigative Site | Heidelberg | Victoria | 3081 | Australia |
| Novartis Investigative Site | Parkville | Victoria | 3050 | Australia |
| Novartis Investigative Site | Prahran | Victoria | 3181 | Australia |
| Novartis Investigative Site | Ottawa | Ontario | K1G 4G3 | Canada |
| Novartis Investigative Site | Gatineau | Quebec | J9J 0A5 | Canada |
| Novartis Investigative Site | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Novartis Investigative Site | Clermont-Ferrand | 63003 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Pessac | 33604 | France |
| Novartis Investigative Site | Bochum | 44791 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Kassel | 34128 | Germany |
| Novartis Investigative Site | Marburg | 35039 | Germany |
| Novartis Investigative Site | München | 80804 | Germany |
| Novartis Investigative Site | Stadtroda | 07646 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Lido di Camaiore | LU | 55041 | Italy |
| Novartis Investigative Site | Roma | RM | 00163 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D004409 | Dyskinesia, Drug-Induced |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D020258 | Neurotoxicity Syndromes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011041 | Poisoning |
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| ID | Term |
|---|---|
| C581397 | mavoglurant |
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