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 (P5.372)

Objective: To examine whether the response to an inhaled levodopa formulation (CVT-301; 35 and 50 mg) 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, oral levodopa dosage at baseline ranged from 250-1800 mg/day. CVT-301 significantly improved UPDRS (Unified Parkinson’s Disease Rating Scale) Part 3 relative to placebo; treatment effect was evident at 10 minutes, the earliest time point assessed.Design/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 gender, PD stage (Hoehn u0026 Yahr; Hu0026Y), 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[percnt] male, 33.7[percnt] 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; Pu003c0.001. The difference in UPDRS Part 3 score between CVT-301 and placebo was independent of gender (male, P=0.03; female, Pu003c0.001), HY ≥2.5, Pu003c0.001), daily OFF time (u003c4 hours, P=0.04; ≥4 hours, Pu003c0.001), 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, defined by change in motor function, did not vary as a function of the demographic and clinical characteristics tested. Disclosure: Dr. LeWitt has received personal compensation for activities with Acorda Pharmaceuticals. Dr. Freed has received personal compensation for activities with Civitas Therapeutics as an employee. Dr. Leinonen has received personal compensation for activities with Civitas Therapeutics. Dr. Sedkov has received personal compensation for activities with Acorda Therapeutics, Inc. Dr. Murck has received personal compensation for activities with Acorda Therapeutics, Inc.