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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT number 2008-008712-98 |
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This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFQ056-10mg | Experimental |
| |
| AFQ056-25mg | Experimental |
| |
| AFQ056-50mg | Experimental |
| |
| AFQ056-75mg | Experimental |
| |
| AFQ056-100mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFQ056 | Drug |
| ||
| AFQ056 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score | 12 weeks | |
| Change from baseline on patient's dyskinesia, disability caused by the dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change |
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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 | East Gosford | 2250 | Australia | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23853029 | Result | Stocchi F, Rascol O, Destee A, Hattori N, Hauser RA, Lang AE, Poewe W, Stacy M, Tolosa E, Gao H, Nagel J, Merschhemke M, Graf A, Kenney C, Trenkwalder C. AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov Disord. 2013 Nov;28(13):1838-46. doi: 10.1002/mds.25561. Epub 2013 Jul 12. |
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|
| AFQ056 | Drug |
|
| AFQ056 | Drug |
|
| AFQ056 | Drug |
|
| Placebo | Drug |
|
| 12 weeks |
| Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale) | 12 weeks |
| Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD | 12 weeks |
| Heidelberg |
| Australia |
| Novartis Investigative Site | Melbourne | 3050 | Australia |
| Novartis Investigative Site | Parkville | 3181 | Australia |
| Novartis Investigational Site | Westmead | NSW 2145 | Australia |
| Quebec Memory & Motor Skills Disorders Clinic | Québec | Quebec | G1R 3X5 | Canada |
| Clinique Neuro-Outaouais | Gatineau | J9J 0A5 | Canada |
| Recherches Pembina, Inc | Greenfield Park | J4V 2J2 | Canada |
| Novartis Investigative Site | Montreal | H2L 4M1 | Canada |
| Parkinson's and Neurodegenerative Disorders Clinic | Ottawa | K1G 4G3 | Canada |
| Toronto Western Hospital, UHN | Toronto | M5T 2S8 | Canada |
| Novartis Investigative Site | Vancouver | V6T 2B5 | Canada |
| Novartis Investigative Site | Kuopio | Finland |
| Novartis Investigative Site | Lahti | 15110 | Finland |
| Novartis Investigative Site | Oulu | 90220 | Finland |
| Novartis Investigative Site | Tampere | 33520 | Finland |
| Novartis Investigative Site | Turku | 20520 | Finland |
| Novartis Investigative Site | Clermont-Ferrand | 63003 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Pessac | 33604 | France |
| Novartis Investigative Site | Saint-Herblain | 44800 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Beelitz-Heilstätten | 14547 | Germany |
| Novartis Investigative Site | Berlin | 13088 | Germany |
| Novartis Investigative Site | Bochum | 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 | 55041 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Roma | 00163 | Italy |
| Novartis Investigative Site | Roma | 00185 | Italy |
| Novartis Investigative Site | Fukuoka | 814-0180 | Japan |
| Novartis Investigative Site | Tochigi | 329-0498 | Japan |
| Novartis Investigative Site | Tokyo | 113-8431 | Japan |
| Novartis Investigative Site | Tokyo | 136-0075 | Japan |
| Novartis Investigative SIte | Tokyo | 187-8551 | Japan |
| Novartis Investigative Site | Tōon | 791-0295 | Japan |
| Novartis Investigative Site | Wakayama | 641-8510 | Japan |
| Novartis Investigative Site | Barcelona | 08036 | Spain |
| Novartis Investigative Site | Barcelona | 08190 | Spain |
| Novartis Investigative Site | Barcelona | Spain |
| Novartis Investigative Site | Donostia / San Sebastian | Spain |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C581397 | mavoglurant |
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