2 Year Study to Evaluate the Effects of GPI 1485 on [123I]b-CIT/SPECTScanning and Clinical Efficacy in Patients With PD
This study was designed to assess whether GPI 1485 has the ability to delay or stop disease progression and improve symptoms in patients with Parkinson's disease (PD) that is already being treated with a dopamine agonist therapy. Whether the drug is working will be assessed by evaluating clinical endpoints such as UPDRS scores and by evaluating images, obtained by SPECT scan, of brain activity. Participants in the study will be given either placebo or GPI 1485 treatment. The duration of the study is 2-years and patients are required to complete 12 safety visits and 3 SPECT scans. SPECT scans will be taken before, after 1-year, and after 2-years of treatment with GPI 1485. In completing the SPECT scan, patients will be injected with a radioactive investigational drug b-CIT and pictures taken using a Single Photon Emission Computed Tomography (SPECT) camera.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- 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.
|Study Start Date:||November 2002|
|Study Completion Date:||October 2005|
In this phase II study, the investigational new drug (not approved by the FDA) GPI 1485 is being assessed for its ability to delay or stop disease progression and improve symptoms in patients with mild to moderate Parkinson's disease (PD). These potential effects of GPI 1485 are based on animal studies in which the drug was shown to both protect nerves from damage and to regrow damaged nerves. Participants in this study will be randomly assigned to receive either GPI 1485 or placebo (inactive pill). GPI 1485 will be supplied as an oral tablet formulation to participants enrolled in the study. Participants randomly assigned to receive GPI 1485 will be required to take four tablets four times a day by mouth. GPI 1485 matching placebo will also be supplied as an oral tablet formulation. Participants randomly assigned to placebo will be required to take four placebo tablets four times a day by mouth. The duration of this study is 24 months which includes 12 clinical visits at one of 21 participating sites and three imaging visits to Molecular NeuroImaging (MNI) in New Haven Connecticut. At MNI, participants will be injected with a radioactive investigational drug b-CIT to obtain images of the activity in the brain with Single Photon Emission Computed Tomography (SPECT). This will evaluate whether GPI 1485 slows or delays the loss of brain activity in patients with mild to moderate PD. During this study you will also have other clinical evaluations including a physical exam, blood work, ECG (tracing of your heart rhythm), and urinalysis. Tests specific to Parkinson's disease will also be performed including: Unified Parkinson's Disease Rating Scale (UPDRS), Dyskinesia Rating Scale, Bilateral finger-tapping test, and Parkinson's Disease Sleep Scale (PDSS). In addition assessments of your health and mood will be done.