Acorda Therapeutics has enrolled its first patient in a phase 3 study of CVT-301 for the treatment of “off” episodes in Parkinson’s disease. “Off” episodes are characterised by a re-emergence of Parkinson’s disease symptoms such as tremor, muscle stiffness and impaired ability to move.
CVT-301 is a novel, self-administered inhaled therapy designed to provide rapid, reliable delivery of a precise dose of levodopa (L-dopa) through the lungs to return people with Parkinson’s disease to an “on” state, when a patient’s symptoms are adequately controlled.
“About 350,000 people with Parkinson’s disease in the USA experience “off” episodes, which can be exceptionally disruptive, impacting their lives on a daily basis, even multiple times per day. We believe CVT-301 has the potential to be an important treatment for people experiencing “off” episodes,” says Enrique Carrazana, Acorda Therapeutics’ chief medical officer.
The multicentre, double blind, randomised trial is expected to enrol 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 (UPDRS) Part III after administration of CVT-301.
Positive results from the CVT-301 phase 2b study were presented at the 2014 American Academy of Neurology Annual Meeting. In this study, participants receiving CVT-301 showed a statistically significant and clinically important reduction in average UPDRS Part III motor score versus placebo across time points beginning at 10 and up to 60 minutes post-administration (p < 0.001). Both doses of CVT-301 were well tolerated, with no increase relative to placebo in troublesome or non-troublesome dyskinesias during “on” periods. There were no serious adverse events in the trial, and the incidence of drug-related adverse events was similar between treatment groups. The CVT-301 inhaler was shown to be easily self-administered in the “off” state.