Santhera's FJORD Phase IIb Study Demonstrates Efficacy of JP-1730for the Treatment of Dyskinesia in Parkinson's Disease
Santhera Pharmaceuticals announced positive data from its Phase IIb study (FJORD). The key finding of the trial is that JP-1730/ fipamezole reduces levodopa-induced dyskinesia in Parkinson's patients. This beneficial effect was not associated with a worsening of Parkinsonian features of the disease. The data additionally suggest that JP-1730/fipamezole reduces "off time" and improves cognitive function as well as clinical global impression in dyskinesia. The compound was found to be safe and well tolerated.
The FJORD study was a double-blind, randomized, placebo-controlled, multiple dose-escalating study of the safety, tolerability and efficacy of JP-1730/fipamezole in the treatment of levodopa-induced dyskinesia in Parkinson's Disease patients. The study investigated the efficacy of three doses (30, 60 and 90 mg) compared to placebo over a treatment period of 28 days in 179 patients enrolled at a total of 33 sites in the US (26) and India (7). The primary study endpoint was the suppression of levodopa-induced dyskinesia as measured by the Levodopa Induced Dyskinesia Scale (LIDS). The LIDS is a modified version of the Abnormal Involuntary Movement Scale, an evaluation tool widely used in clinical research.
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