VANCOUVER, BC—Parkinson’s disease (PD) “off”-period symptoms control is better than placebo following administration of an inhaled levodopa powder formulation (CVT-301), according to an analysis of patient-reported outcomes data from a randomized, double-blind, placebo-controlled Phase 2b study, presented at the 68th AAN Annual Meeting.
“[M]ost patients using CVT-301, an inhaled levodopa formulation for treatment of OFF periods for PD control, reported an improved experience as measured by PGI-C [Patient Global Impression of Change] rating,” lead study author Peter A. LeWitt, MD, of the Henry Ford Hospital in West Bloomfield, MI, and coauthors reported in a poster presentation. “These findings are in concordance with improved motor function and reduction in daily OFF-time observed for patients in this study treated with CVT-301, as has been reported elsewhere.”
“In general, CVT-301 was safe and well-tolerated,” they reported.
The researchers had randomly assigned (1:1) a total of 86 patients with PD who were experiencing at least 2 hours OFF time per day, to self-administer either CVT-301 (n=43) or placebo (n=43) as an adjunct to standard treatment (oral levodopa/levodopa-decarboxylase inhibitor) for OFF symptoms, the coauthors wrote. Two doses of CVT-301 were studied: 35mg (“dosing level 1” [DL1] during Weeks 1 and 2]), and 50mg (DL2) during Weeks 3 and 4. PGI-C ratings were collected from patients at the conclusion of each dosing level period (at the end of Weeks 2 and 4).
PGI-C ratings were completed by 79 patients at the conclusion of DL1 and 74 patients after DL2. Ratings from patients in the placebo and CVT-301 study arms were compared using a chi-square tests.
“A majority of [CVT-301] patients reported improvement of PD (DL1: 65%; DL2: 71.8%),” the researchers reported. In contrast, less than half of patients in the placebo group, reporting improvement (43.6% in DL1 and 45.7% in DL2).
“Compared with placebo, treatment with CVT-301 was associated with a significantly favorable impression at DL2 (71.8% vs. 45.7%; P=0.0225) and a favorable impression trending toward significance at DL1 (65.0% vs. 43.6; P=0.0561),” they reported.
Baseline demographic and clinical characteristics for patients in the CVT-301 study arm did not impact PGI-C ratings in stratified analyses.
Treatment-emergent adverse events (TEAEs, most commonly cough, dizziness, or nausea) were reported for 20 (47%) patients in the CVT-301 study arm and 14 (33%) patients in the placebo group; severe and serious TEAEs occurred in a total of three placebo-group participants.
The study was funded by Civitas Therapeutics, which is wholly-owned by Acordia Therapeutics. Dr. LeWitt disclosed advisory, consulting, speaking and research support from Acordia Therapeutics.