Session Information
Date: Thursday, June 23, 2016
Session Title: Parkinson's Disease: Clinical Trials II and Non-PD Clinical Trials
Session Time: 12:00pm-1:30pm
Objective: To examine whether the response to an inhaled levodopa formulation (CVT-301; at 35 and 50 mg per dose) is dependent on baseline patient characteristics.
Background: Many patients with Parkinson’s disease (PD) treated with levodopa experience motor fluctuations (OFF episodes) after a period of good motor control. CVT-301, levodopa inhalation powder formulation, is under development for rapid relief of OFF episodes. In a Phase 2b study, with baseline oral levodopa dosage ranging from 250–1800 mg/day, CVT-301 significantly improved UPDRS (Unified Parkinson’s disease Rating Scale) Part 3 scores relative to placebo; treatment effect was evident at 10 minutes (the earliest time point assessed).
Methods: Data were derived from a Phase 2b study (CVT-301-003; NCT01777555). CVT-301 and placebo were self-administered up to 3 times/day. Dose was escalated from 35 mg (weeks 1 and 2) to 50 mg (weeks 3 and 4). Baseline characteristics, including sex, PD stage (Hoehn &Yahr; H&Y), dyskinesia, and daily OFF time, were examined for possible influence on UPDRS Part 3 changes in CVT-301 versus placebo (end of week 4). Tolerability was assessed. Additional analyses will be performed.
Results: Eighty-six patients were randomized 1:1 to CVT-301 or placebo; 66.3% male, 33.7% female, mean age 62.4 years (range 37–79). At week 4, the mean change in UPDRS Part 3 was –10.02 (CVT-301) versus –3.07 (placebo), treatment effect of –6.95; P<0.001. The difference in UPDRS Part 3 score between CVT-301 and placebo was independent of sex (male, P=0.03; female, P<0.001), H&Y (<2.5, P=0.04; ≥2.5, P<0.001), daily OFF time (<4 hours, P=0.04; ≥4 hours, P<0.001), and presence of dyskinesia (YES, P=0.004; NO, trend with P=0.07). CVT-301 was tolerated during the 4-week study.
Conclusions: AntiParkinsonian efficacy of CVT-301, defined as change in motor function, did not vary as a function of the demographic and clinical characteristics tested.
To cite this abstract in AMA style:
P.A. LeWitt, M.I. Freed, M. Leinonen, A. Sedkov, H. Murck. Effect of patient characteristics on motor function in response to 35–50 mg of inhaled levodopa (CVT-301) in patients with Parkinson’s disease: Results from a phase 2b study [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/effect-of-patient-characteristics-on-motor-function-in-response-to-35-50-mg-of-inhaled-levodopa-cvt-301-in-patients-with-parkinsons-disease-results-from-a-phase-2b-study/. Accessed May 13, 2025.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/effect-of-patient-characteristics-on-motor-function-in-response-to-35-50-mg-of-inhaled-levodopa-cvt-301-in-patients-with-parkinsons-disease-results-from-a-phase-2b-study/