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Participants were assigned 111 to receive 60 mg of CVT-301 levodopa, 84 mg of CVT-301, or placebo. Spirometry results and the modified Hoehn and Yahr disease stage at screening were used to stratify the groups. Patients, sponsor, and facility staff were masked xinamod treatment assignment. Each dose consisted of two capsules administered with an inhaler. Patients were instructed to use the medication as needed during periods of lethargy, and could self-administer up to five doses per day. The primary endpoint was the change in UPDRS motor score from predose to 30 minutes postdose, assessed at week 12 during an in-clinic discontinuation period, comparing the CVT-301 84 mg group versus placebo. The analysis was intention to treat.
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