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Protocol ADX48621-301: Phase 2b/3, Randomized, Double-blind, Placebo controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment of Dyskinesia in Patients with Parkinson's Disease Receiving Levodopa-based Therapy With or Without Concomitant Dopaminergic Medications
This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.
This is a prospective, open-label, single-arm, multicenter, observational, longitudinal study designed to describe the outcomes observed with use of ONGENTYS as adjunctive treatment to LD/CD in treating PDeOE patients. (Opti-on)
To describe patterns, clinical outcomes, and safety/tolerability in PDeOE receiving opicapone (ONGENTYS) as an adjunctive treatment to levodopa/carbidopa (LD/CD) over a 6-month period.

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