Abstract Details

Title SPAN-PD: Subgroup Analyses by Baseline Characteristics of Patients Treated With Levodopa Inhalation Powder 84mg or Placebo to Treat OFF Symptoms in Patients With Parkinson’s Disease (PD) as Measured by Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) Score and Patient Global Impression of Change (PGIC)

Topic Movement Disorders

Presentation(s) P10 - Poster Session 10 (8:00 AM-9:00 AM)

Poster/Presentation
Number 5-005

Background SPAN-PD was a randomized, double-blind, placebo-controlled study of CVT-301 efficacy/safety in PD patients on a stable levodopa-dopa-decarboxylase inhibitor regimen experiencing ≥2h daily OFF periods.

Objective UPDRS-III score (primary endpoint) and PGIC changes after levodopa inhalation powder (CVT-301) 84mg treatment were compared for baseline subgroups of patients in the phase 3, SPAN-PD study.

Design/Methods Patients were randomized to placebo/CVT-301 for treatment of OFF symptoms as needed ≤5 times/day. Analyses compared treatment differences between CVT-301 84mg and placebo for UPDRS-III scores measured at 30min at week 12 visit, and PGIC after 12 weeks for the following subgroups at baseline: Hoehn & Yahr scale (<2.5 vs ≥2.5), dyskinesia (≥1h of dyskinesia on ≥2 days before baseline vs no dyskinesia), daily LD dose ≤ vs > median (750mg), daily OFF time (<4.5 vs ≥4.5h), age (< 65 vs ≥ 65y), and male/female. Mixed model for repeated measures used change from predose UPDRS-III score as dependent variable, and included treatment group, visit, stratification variables, and interaction between treatment group and visit as fixed factors, and OFF-state baseline UPDRS-III score as covariate. Subgroup analyses for PGIC were performed using repeated measures logistic regression model with the same independent variables. Treatment by subgroup variable interaction was tested one at the time for both measures.

Results Overall, CVT-301 84mg improved motor function at week 12, 30min postdose, as measured by lower UPDRS-III scores (LS difference -3.92 CVT-301 vs placebo, P=0.009). 71.4% of patients in the CVT-301 group reported PGIC improvement vs 46.4% on placebo (nominal P<0.001) after 12 weeks of use.Subgroup analyses showed there were no significant differences between subgroups for UPDRS-III and PGIC changes. CVT-301 treatment resulted in greater treatment benefit vs placebo.

Conclusions In these subpopulations of patients experiencing OFF periods in SPAN-PD, CVT-301 was effective in improving motor function and patient-reported impression of change.

Authors/Disclosures
Stuart H. Isaacson, MD, FAAN (Parkinson's Dis & Mov Dis Ctr of Boca Raton) PRESENTER	The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for acorda. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for adamas. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neuroderm. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for adamas. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acadia. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
	No disclosure on file
Burkhard Blank	Burkhard Blank has received personal compensation for serving as an employee of Acorda Therapeutics. Burkhard Blank has received stock or an ownership interest from Acorda Therapeutics, Inc.