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Randomized Controlled Trial
. 2019 Jul:64:175-180.
doi: 10.1016/j.parkreldis.2019.03.026. Epub 2019 Mar 30.

Orally inhaled levodopa (CVT-301) for early morning OFF periods in Parkinson's disease

Robert A Hauser  1 , Stuart H Isaacson  2 , Aaron Ellenbogen  3 , Beth E Safirstein  4 , Daniel D Truong  5 , Steven F Komjathy  6 , Deena M Kegler-Ebo  6 , Ping Zhao  6 , Charles Oh  6
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Free article
Randomized Controlled Trial

Orally inhaled levodopa (CVT-301) for early morning OFF periods in Parkinson's disease

Robert A Hauser et al. Parkinsonism Relat Disord. 2019 Jul.
Free article

Abstract

Background: CVT-301 (Inbrija) is a self-administered orally inhaled levodopa approved for the intermittent treatment of OFF episodes in patients with Parkinson's disease (PD) treated with carbidopa/levodopa. Prior studies only evaluated CVT-301 after the first ON of the day.

Objective and methods: The objective of this study was to evaluate the safety and tolerability of CVT-301 for early morning OFF. Using a randomized, double-blind, 2-way crossover design, eligible patients in the morning OFF state (having not received PD medication overnight) received a single dose of CVT-301 84 mg or placebo on 2 dosing days, immediately after their first morning oral carbidopa/levodopa dose. Safety assessments included treatment-emergent adverse events, vital signs, and patient- and examiner-reported dyskinesia. An exploratory efficacy assessment was examiner-rated time-to-ON with carbidopa/levodopa + CVT-301 vs carbidopa/levodopa + placebo.

Results: Of the 36 patients (mean age 62.9 years) who enrolled and completed the study, 9 (25.0%) reported treatment-emergent adverse events following CVT-301 administration; 4 (11.1%) reported treatment-emergent adverse events following placebo. The most common adverse event was cough (4 [11.1%] for CVT-301 vs 1 [2.8%] for placebo), which was typically mild and transient. Incidence of asymptomatic orthostatic hypotension (CVT-301, 6; placebo, 7) and examiner-rated dyskinesia were similar for both (36-39% mild, 3-6% moderate, and 0% severe). Median time-to-ON was 25.0 min following carbidopa/levodopa + CVT-301 and 35.5 min following carbidopa/levodopa + placebo (P = 0.26). At 30 min, more patients had turned ON following carbidopa/levodopa + CVT-301 administration (66.7%), compared with carbidopa/levodopa + placebo (44.5%) (P = 0.040).

Conclusion: Single doses of CVT-301 84 mg administered with oral carbidopa/levodopa for early morning OFF symptoms were well-tolerated, with no notable safety concerns.

Keywords: CVT-301; Carbidopa; Inbrija; Inhalation; Levodopa; OFF periods.

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