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SNDC Halts Study of GPI 1485 for Parkinsonís Disease
- Mar 08 2006
Due to lack of evidence of clinical benefit, Symphony Neuro Development Company (SNDC) and its clinical advisors have decided to stop further drug treatment in its open-label study (Protocol 0501-0404) of GPI 1485 in Parkinsonís disease patients who had previously participated in the recently completed 2 year double blind efficacy study (Protocol 0501-0201). GPI 1485 is an investigational drug that had been hoped to help damaged nerves regenerate.
The decision to take this action was made after careful analysis of the data from Protocol 0501-0201, which was a phase 2, multi-center, randomized, double-blind, placebo-controlled, 2-year study of GPI 1485. The study enrolled 212 patients with mild to moderate Parkinsonís disease who were being treated solely with a dopamine agonist. Patients received either placebo or 1000 mg of GPI 1485 four times a day in addition to symptomatic therapy.
While the treatment was well tolerated and posed no significant safety issues, the treatment group failed to show an improvement in the primary endpoint of the trial which was percent change of baseline of brain uptake of [123I}Beta-CIT as measured by SPECT Scanning, a measure of the brain dopamine system that degenerates in Parkinsonís disease. Beta-CIT is a radioactive tracer that binds to the site where dopamine is released, called the dopamine transporter. The uptake of the tracer corresponds to the quantity of dopamine neurons. In this study, the beta-CIT imaging was performed at baseline, and again at subsequent intervals, providing a measure of the dopamine cell loss over time. In addition, none of the exploratory clinical endpoints showed clinically meaningful benefit after 24 months of therapy. The clinical measurements in the trial included average daily dopaminergic drug therapy and the Unified Parkinsonís Disease Rating Scale (UPDRS) as well as tests of sleep, cognition, mood and quality of life.
SNDC has determined that it is in the best interests of the patients to discontinue further therapy in the open-label extension study because no benefit has been demonstrated. The company believes it is important that patients currently enrolled in the study have the immediate opportunity to seek other potentially beneficial therapies. With the stopping of treatment, additional SPECT scans will also be suspended.
SNDC plans to present full results of the efficacy study at an appropriate scientific meeting as soon as is practical and submit the results for publication. In the coming months, the company will work with the trialís steering committee and the investigators on the abstract and manuscript.
Source Date: Mar 08 2006