Abstract Details

Title Randomized, Double-Blind, Double-Dummy Study of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson's Disease: Efficacy Analyses by Subgroups

Topic Movement Disorders

Presentation(s) S23 - (-)

Poster/Presentation
Number 003

Objective

Background Fluctuating blood levels of levodopa are associated with motor complications in PD. LCIG is delivered continuously via an intrajejunal percutaneous gastrostomy tube.

Design/Methods A double-blind, double-dummy trial evaluated LCIG compared with oral LC-IR therapy in patients with advanced PD and motor fluctuations. Levodopa-responsive patients received LCIG infusion + placebo capsules or encapsulated levodopa-carbidopa IR tablets + placebo gel infusion for 12 weeks. The primary endpoint was the change from baseline to Week 12 in "Off" time normalized to 16 waking hours. "On" time without troublesome dyskinesia was a key secondary outcome. Efficacy was analyzed by subgroups including gender, age (<65 or ?65 years), disease duration (<10 or ?10 years), PD severity (

Results 71 patients were randomized (n=37 LCIG; n=34 IR), and 66 (93%) completed the trial. LCIG significantly improved "Off" time (LS mean difference = -1.91 hr; P=0.0015) and "On" time without troublesome dyskinesia (LS mean difference = 1.86 hr, P=0.0059) compared with IR. Subgroup analyses of the change from baseline in "Off" time revealed no statistically significant interaction of treatment group by gender (P=0.589), age (P=0.935), disease duration (P=0.135), symptom severity (P=0.697), number of PD medications at baseline (P=0.237), or history of dopamine agonist use (P=0.171).

Conclusions These results demonstrate the robust and consistent efficacy of LCIG, compared with optimized oral levodopa-carbidopa therapy, irrespective of differences in gender, age, PD duration, PD severity, number of PD medications, or dopamine agonist use at baseline.

Authors/Disclosures
Angelo Antonini, MD PRESENTER	Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BIAL. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ABBVIE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Antonini has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for THERAVANCE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ROCHE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ABBVIE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ZAMBON. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BOEHRINGER.
Krai Chatamra, PhD (InTrance Medical Systems)	No disclosure on file
Weining Robieson, PhD (AbbVie)	Dr. Robieson has received personal compensation for serving as an employee of AbbVie. Dr. Robieson has received stock or an ownership interest from AbbVie.
Todd D. Levine, MD (Honor Health)	Dr. Levine has received personal compensation for serving as an employee of CND life sciences . Dr. Levine has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Nufactor. Dr. Levine has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for PNA. Dr. Levine has stock in CND Life Sciences. Dr. Levine has stock in Corinthian reference lab.
	No disclosure on file
Katherine L. Widnell, MD, PhD (UCLA Health Burbank Neurology)	No disclosure on file
Janet Benesh, BSMT (Abbott Laboratories)	No disclosure on file
Robert Lenz, MD	No disclosure on file
Maria G. Marrosu	No disclosure on file

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