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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001092-39 | EudraCT Number |
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This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AQW051 High Dose | Experimental | AQW051 high dose daily given orally for 28 days. |
|
| AQW051 Low Dose | Experimental | AQW051 low dose daily given orally for 28 days. |
|
| Placebo | Placebo Comparator | Placebo daily given orally for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQW051 | Drug | Patients will receive AQW051 in a high dose once daily orally for 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score | Dyskinesia with a maximal score of 24. | Baseline, Day 28 |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score | Anti-parkinsonian effect in PD patients. | Baseline, Day 28 |
| Safety and tolerability | Safety and tolerability of AQW051 as measured by the number of participants with adverse events, any clinically significant abnormalities in safety labs or electrocardiograms (ECGs), and relevant orthostatic changes in blood pressure | Up to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) | Assesses the degree to which dyskinesia interferes with five activities of daily living, with a higher score indicating more severe impairment. | Up to Day 42 |
| Unified Parkinson's Disease Rating Scale (UPDRS) - Part IV, #32-33 |
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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 | Sacramento | California | 95817 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26990766 | Result | Trenkwalder C, Berg D, Rascol O, Eggert K, Ceballos-Baumann A, Corvol JC, Storch A, Zhang L, Azulay JP, Broussolle E, Defebvre L, Geny C, Gostkowski M, Stocchi F, Tranchant C, Derkinderen P, Durif F, Espay AJ, Feigin A, Houeto JL, Schwarz J, Di Paolo T, Feuerbach D, Hockey HU, Jaeger J, Jakab A, Johns D, Linazasoro G, Maruff P, Rozenberg I, Sovago J, Weiss M, Gomez-Mancilla B. A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia. Mov Disord. 2016 Jul;31(7):1049-54. doi: 10.1002/mds.26569. Epub 2016 Mar 15. |
| Label | URL |
|---|---|
| Results for CAQW051A2209 from the Novartis Clinical Trials Website | View source |
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| AQW051 | Drug | Patients will receive AQW051 in a low dose once daily orally for 28 days. |
|
| Placebo | Drug | Patients will receive placebo once daily orally for 28 days. |
|
Dyskinesias as a percentage of the day, and disability due to dyskinesia during the previous week. |
| Up to Day 42 |
| Track-PD | Objective measures of motor function. | Up to Day 42 |
| CogState | Cognitive function, including simple and choice reaction time, episodic visual and verbal memory, working memory, planning and strategy, and executive function. | Up to Day 28 |
| Area under the curve (AUC[0-24hr]) of AQW051 | Day 28 |
| Manhasset |
| New York |
| 11030 |
| United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45219 | United States |
| Novartis Investigative Site | Cleveland | Ohio | 44195 | United States |
| Novartis Investigative Site | Bron | 69677 | France |
| Novartis Investigative Site | Clermont Fd | 63003 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Marseille | 13385 | France |
| Novartis Investigative Site | Montpellier | 34295 | France |
| Novartis Investigative Site | Nantes | 44093 | France |
| Novartis Investigative Site | Paris | 75013 | France |
| Novartis Investigative Site | Pessac | 33604 | France |
| Novartis Investigative Site | Poitiers | 86021 | France |
| Novartis Investigative Site | Strasbourg | 67098 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Berlin | 10178 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Gera | 07551 | Germany |
| Novartis Investigative Site | Haag | 83527 | Germany |
| Novartis Investigative Site | Kassel | 34128 | Germany |
| Novartis Investigative Site | Marburg | 35039 | Germany |
| Novartis Investigative Site | München | 80804 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Roma | RM | 00163 | Italy |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D010300 | Parkinson Disease |
| D009069 | Movement 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 |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C000602881 | 3-(6-p-tolylpyridin-3-yloxy)-1-azabicyclo(2.2.2)octane |
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