Abstract Details

Title Interim Results from an International, Open-Label Study of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson's Disease: Efficacy Analyses by Subgroups

Topic Movement Disorders

Presentation(s) P01 - (-)

Poster/Presentation
Number 060

Objective

Background Fluctuating blood levels of levodopa are associated with motor complications PD. LCIG is delivered continuously via a percutaneous endoscopic gastrojejunostomy (PEG-J) tube.

Design/Methods An international, 54-week, open-label study of LCIG in patients with advanced PD experiencing motor fluctuations despite optimized standard therapy is ongoing (NCT00335153). Individualized LCIG dosing was instructed to be 16 hr/day. Efficacy outcomes included "Off" time and "On" time with and without troublesome dyskinesia. This interim analysis included assessments performed on or prior to the data cutoff date of Nov. 25, 2011. Efficacy endpoints were tabulated across 16 enrolling countries, and were analyzed by subgroups of gender, age (<65 yrs or ?65 yrs), PD duration (<10 yrs or ?10 yrs), and the number of PD medications at baseline (1-2 or ?3).

Results At data cutoff, 354 subjects had nasojejunal tube insertion and 323 had received subsequent PEG-J tube. For all countries combined, both mean "Off" time and "On" time without troublesome dyskinesia were significantly improved at all time points compared with baseline. Significant baseline differences were detected among countries for age (P<0.001), PD duration (P<0.001) and mean "Off" time (P=0.038). In each country, the change from baseline in "Off" time and "On" time without troublesome dyskinesia was significantly improved (P<0.05) as early as Week 4, and sustained through Week 54. Improvements in mean "Off" time and "On" time without troublesome dyskinesia were not affected by age, PD duration, or the number of PD medications at baseline.

Conclusions LCIG produced significant and consistent improvements in motor function in advanced PD patients experiencing motor fluctuations.

Authors/Disclosures
Per Odin PRESENTER	Per Odin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Per Odin has received personal compensation in the range of $0-$499 for serving as a Consultant for Britannia. Per Odin has received personal compensation in the range of $0-$499 for serving as a Consultant for Convatec. Per Odin has received personal compensation in the range of $0-$499 for serving as a Consultant for UCB.
Alberto J. Espay, MD, FAAN (University of Cincinnati)	Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Tanabe Pharma America (formerly, Neuroderm). Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acorda. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Herantis Pharma. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus (formerly USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Synaps Dx. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bial. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NeuroDiagnostics, Inc (SYNAPS Dx). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Intrance Medical Systems, Inc.. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Praxis Precision Medicines. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Citrus Health. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AskBio. The institution of Dr. Espay has received research support from NIH. The institution of Dr. Espay has received research support from Michael J Fox Foundation for Parkinson's Research. Dr. Espay has received intellectual property interests from a discovery or technology relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care.
Douglas L. Arnold, MD, FAAN (Montreal Neurological Institute, McGill Univ)	Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Frequency Therapeutics. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xfacto communications. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Find therapeutics. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kiniksa. Dr. Arnold has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Clario.
	No disclosure on file
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center)	Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Supernus. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoparkinson. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Intrance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zambon. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NanoPharmasolutions. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll BioPharma. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Cerevance. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Clario. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sumitomo. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Taurus Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sorriddi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Contera. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alterity Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Convatec Inc. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Knight Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biorasi. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medicure Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BlueRock. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inhibikase. The institution of Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Stoparkinson. The institution of Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Photopharmics. The institution of Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal . Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Hauser has or had stock in Inhibikase.Dr. Hauser has or had stock in Axial Therapeutics.Dr. Hauser has or had stock in Enterin.Dr. Hauser has or had stock in Photopharmics. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. The institution of Dr. Hauser has received research support from Inhibikase Therapeutics. The institution of Dr. Hauser has received research support from AbbVie, Inc.. The institution of Dr. Hauser has received research support from Biogen MA. The institution of Dr. Hauser has received research support from Cavion, Inc.. The institution of Dr. Hauser has received research support from Cerevance Beta, Inc.. The institution of Dr. Hauser has received research support from Cerevel Therapeutics. The institution of Dr. Hauser has received research support from Enterin, Inc.. The institution of Dr. Hauser has received research support from Genentech. The institution of Dr. Hauser has received research support from Global Kinetics Corporation. The institution of Dr. Hauser has received research support from Hoffman-La Roche Inc. The institution of Dr. Hauser has received research support from Michael J. Fox Foundation for Parkinson's Research. The institution of Dr. Hauser has received research support from National Parkinson's Foundation. The institution of Dr. Hauser has received research support from Neuroderm. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from UCB BioPharma. The institution of Dr. Hauser has received research support from UCB. The institution of Dr. Hauser has received research support from Amneal Pharmaceuticals. The institution of Dr. Hauser has received research support from Motric Bio, Inc.. The institution of Dr. Hauser has received research support from Sun Pharma Advanced Research Company. The institution of Dr. Hauser has received research support from Teva Branded Pharmaceuticals. The institution of Dr. Hauser has received research support from Truebinding, Inc.. The institution of Dr. Hauser has received research support from Jazz Pharmaceuticals. The institution of Dr. Hauser has received research support from Ipsen. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
Hubert H. Fernandez, MD, FAAN (Center for Neurological Restoration, Cleveland Clinic)	Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Intrance. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Fernandez 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. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Fernandez has received publishing royalties from a publication relating to health care. Dr. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as a Steering Committee/Advisory Committee Member with Parkinson Study Group.
David G. Standaert, MD, PhD, FAAN (Univ of Alabama - Dept of Neurology)	Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie, Inc. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Curium. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CVS/Pharmacy. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll Biopharma. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilly. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for F. Hoffman LaRoche. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Aventis. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theravance, Inc. Dr. Standaert has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for International Parkinson and Movement Disorder Society. The institution of Dr. Standaert has received research support from Abbvie, Inc. The institution of Dr. Standaert has received research support from American Parkinson Disease Association. The institution of Dr. Standaert has received research support from National Institutes of Health. The institution of Dr. Standaert has received research support from F. Hoffman LaRoche. Dr. Standaert has received publishing royalties from a publication relating to health care. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Reviewer with National Institutes of Health. Dr. Standaert has a non-compensated relationship as a Chair, Scientific Advisory Board with American Parkinson Disease Association that is relevant to AAN interests or activities.
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.
	No disclosure on file
Katherine L. Widnell, MD, PhD (UCLA Health Burbank Neurology)	No disclosure on file
Krai Chatamra, PhD (InTrance Medical Systems)	No disclosure on file
Janet Benesh, BSMT (Abbott Laboratories)	No disclosure on file
Robert Lenz, MD	No disclosure on file

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