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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011144-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Teva Branded Pharmaceutical Products R&D, Inc. | INDUSTRY |
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The primary endpoint for this study is the clinical response after 12 weeks of treatment, defined as a change in total score from baseline depressive symptoms as measured by the Beck Depression Inventory-Amended (BDI-IA) total score.
ACCORDO is a multicentre, randomised, double-blind, and placebo-controlled study conducted in 12 Italian centres. Subjects are screened by means of the BDI-IA (cut-off 15) and randomised to treatment with rasagiline or placebo for 12 weeks.
Subjects have to be on stable treatment with dopaminergic agents at least 4 weeks before baseline, and maintained so during the course of the study.
The primary objective is to evaluate whether rasagiline compared to placebo improves depressive symptoms as evaluated by the BDI-IA total score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rasagiline | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasagiline | Drug | 1 mg/day for 12 weeks; orally |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in BDI-IA total score | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate if rasagiline compared to placebo improves cognitive function, over a treatment period of 12 weeks in idiopathic Parkinson´s Disease, using a formal neuropsychiatric cognitive test battery; quality of life (PDQ 39); apathy; ADL, motor function | 12 weeks | |
| Change in quality of life using the PDQ-39 scale |
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Inclusion Criteria:
Exclusion Criteria:
A subject, who meets one or more of the following criteria at the Baseline Visit, is not eligible for inclusion in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IT010 | Cagliari | 9134 | Italy | |||
| IT007 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 2009-011144-19 | EMA EudraCT Results | View IPD |
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| Placebo | Drug | Once daily for 12 weeks; orally |
|
| 12 weeks |
| Change in apathy using the Apathy Scale | 12 weeks |
| Change in ADL and motor function using UPDRS scales part II and III, respectively | 12 weeks |
| Chieti |
| 66013 |
| Italy |
| IT004 | Genova | 16132 | Italy |
| IT005 | Lido di Camaiore | 55043 | Italy |
| IT003 | Messina | 98122 | Italy |
| IT012 | Milan | 20135 | Italy |
| IT001 | Naples | 80131 | Italy |
| IT011 | Roma | 161 | Italy |
| IT008 | Rome | 133 | Italy |
| IT015 | Torino | 10126 | Italy |
| IT013 | Venezia | 30126 | Italy |
| IT009 | Verona | 37134 | Italy |
| ID | Term |
|---|---|
| D003863 | Depression |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| 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 |
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| ID | Term |
|---|---|
| C031967 | rasagiline |
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