2 Year Study to Evaluate the Effects of GPI 1485 on [123I]b-CIT/SPECTScanning and Clinical Efficacy in Patients With PD
|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)|
|Estimated 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|
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209508
|Study Director:||Antonella Favit-Van Pelt, MD, PhD||Eisai Inc.|