Titan Pharmaceuticals: First patient treated in ropinirole implant trial
Titan Pharmaceuticals announced that the first patient has been treated in a Phase 1/2 trial of the company's ropinirole implant intended for the treatment of the signs and symptoms of idiopathic Parkinson's disease. This study is being conducted at three clinical research sites in the U.S. that specialize in the treatment of Parkinson's disease. The trial is an open-label, sequential, dose escalation study that will enroll approximately 20 subjects with idiopathic Parkinson's disease. The primary objectives are to characterize the pharmacokinetic profile of the ropinirole implants, to evaluate their safety and tolerability, and to explore potential signals of efficacy using established disease-specific assessment scales. Patients on a stable dose of L-dopa plus oral ropinirole will have their oral ropinirole switched to ropinirole implants for three months of treatment. Initial data from the first cohort of patients is expected in the first quarter of 2018 and the study completion is targeted for the end of next year.