2 Year Study to Evaluate the Effects of GPI 1485 on [123I]b-CIT/SPECTScanning and Clinical Efficacy in Patients With PD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00209508|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 7, 2008
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: GPI 1485||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 2-Year Study To Evaluate The Effects Of GPI 1485 On [123I]b-CIT/SPECT Scanning And Clinical Efficacy In Symptomatic PD Patients Receiving Dopamine Agonist Therapy.|
|Study Start Date :||November 2002|
|Actual Study Completion Date :||October 2005|
- To evaluate the efficacy of GPI 1485 vs. placebo on the percent change from baseline in [123I]ß-CIT/SPECT striatal uptake over 2 years in patients with idiopathic PD.
- To evaluate the efficacy of GPI 1485 vs. placebo in the treatment of symptomatic idiopathic PD patients using the following prespecified clinical measures of greatest interest:
- Mean daily L-Dopa Therapy Equivalents
- UPDRS ('On')
- Measures of sleep
- Cognitive function
- To evaluate the efficacy of GPI 1485 versus placebo using the following other acceptable measures of clinical assessment.
- To evaluate the efficacy of GPI 1485 versus placebo on the percent change from baseline in [123I]ß-CIT/SPECT putamen and caudate uptake over 2 years in patients with idiopathic PD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209508
|Study Director:||Antonella Favit-Van Pelt, MD, PhD||Eisai Inc.|