Date: 2016-04-07
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Acorda Therapeutics (USA - NY)
Product: CVT 301 (levodopa inhalation powder)
Action
mechanism: CVT-301 is an inhaled levodopa (L-dopa) under development for the treatment of OFF periods in Parkinson’s disease. OFF periods are characterized by a re-emergence of PD symptoms, including motor symptoms such as the impaired ability to move, muscle stiffness and tremor. This re-emergence can occur even when treatment regimens, including oral L-dopa and other PD medications, have been optimized. CVT-301 utilizes Acorda’s ARCUS® platform for inhaled therapeutics, which delivers a precise dose of a dry powder formulation of levodopa to the lung. Oral medication can be associated with slow onset of action, as the medicine is absorbed through the gastrointestinal (digestive) tract before reaching the brain. Inhaled treatments, such as those that utilize our ARCUS technology, enter the body through the lungs and reach the brain shortly thereafter, bypassing the digestive system.
Disease: idiopathic Parkinson's disease
Therapeutic area: Neurodegenerative diseases
Country: Canada, Czech Republic, Poland, Spain, USA
Trial
details: This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in Parkinson's disease patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic. Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study . (NCT02240030)
Latest
news: * On April 7, 2016, Acorda Therapeutics announced that data from a Phase 2b clinical trial of CVT-301 in Parkinson’s disease will be featured during the Movement Disorders Invited Science Session at the upcoming 68th Annual Meeting of the American Academy of Neurology, being held in Vancouver, Canada. Based on the results of the Phase 2b trial, Acorda has initiated a Phase 3 clinical trial that is expected to enroll approximately 345 participants across three arms: 50mg, 35mg, or placebo. These are the same doses used in the Phase 2b study. The primary outcome measure is improvement on the Unified Parkinson’s Disease Rating Scale Part 3 (UPDRS III) after administration of CVT-301 in patients experiencing an OFF period (30 minutes post dose). UPDRS III is an established scale to monitor PD motor impairment, and is considered a standard in the field.
