CVT-301 provides immediate onset of a large and precise dose of L-dopa.
The Phase 2a study is a randomized, placebo-controlled, single dose, cross-over design that will feature the safety and tolerability of CVT-301.
The trial also will study pharmacodynamic effects and L-dopa pharmacokinetics in patients with Parkinson’s disease with motor fluctuations.
The study will also asses the dose for future clinical trials with CVT-301. Patients will receive oral Sinemet, inhaled placebo and CVT-301 which will be followed by a series of evaluations of L-dopa pharmacokinetics, motor response and safety at each visit.
Twenty-four patients will participate in the trial.
Civitas co-founder Dr.Martin Freed said,”Consistent with our commitment to rapidly develop important new therapies for patients, we demonstrated pharmacokinetic proof-of-concept for CVT-301 in less than 12 months from launching Civitas and are now initiating this Phase 2a study in Parkinson’s patients."