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Abstract Details

Levodopa-Carbidopa Intestinal Gel for the Treatment of Motor Fluctuations and Dyskinesia in Patients with Advanced Parkinson’s Disease in a ‘Real World’ Setting: Results of an Interim Analysis of the Multinational Observational Long-term Study DUOGLOBE
Movement Disorders
S4 - Clinical Trials in Movement Disorders (1:33 PM-1:44 PM)
004
Although LCIG improves “Off” time in advanced PD patients, prospective, long-term, multinational data on dyskinesia and other outcomes in routine clinical practice are limited.

Assess the effectiveness of levodopa-carbidopa intestinal gel (LCIG) on motor fluctuations and dyskinesias in advanced Parkinson’s disease (PD) patients treated in routine clinical practice.


DUOGLOBE is the first multinational observational study of LCIG in routine care, including US sites, with 3-years follow-up. The primary outcome is mean change in patient-reported “Off” time; secondary outcomes include dyskinesia duration and severity, as measured by the recently developed Unified Dyskinesia Rating Scale (UDysRS). Outcomes were collected at baseline, and at scheduled visits closest to months (M) 3, 6, and 12 (± 14 days) in this interim analysis.

139 patients are included in this interim analysis (78% ≥65 years old; 51% ≥10 years’ disease duration), and sample sizes became limited over time due to patients not yet achieving later visits. LCIG treatment significantly reduced patient-reported “Off” time (mean decrease from baseline to M12: -4.1 hours) irrespective of sex, age, and disease duration. Dyskinesia assessed by UDysRS significantly improved and was maintained through M12 (mean decrease from baseline: -12.7). Improvements according to UPDRS part IV scores for duration of “Off” time (through M12), dyskinesia duration (through M6), dyskinesia-related disability (through M12), and dyskinesia-related pain (through M12) were also observed. Safety was consistent with LCIG’s known profile.


This interim analysis confirms the improvement in “Off” time with LCIG in routine clinical practice. This first analysis using UDysRS, and supporting data from UPDRS part IV, showed that LCIG treatment was also associated with a reduction in dyskinesia duration and severity. These findings provide further evidence for the real-world effectiveness of LCIG on motor fluctuations and duration and severity of dyskinesia.


Authors/Disclosures
Pavnit Kukreja, PharmD (AbbVie)
PRESENTER
Dr. Kukreja has received personal compensation for serving as an employee of AbbVie. Dr. Kukreja has stock in AbbVie.
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 Pharma. Dr. Standaert has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Gray Matter Technologies. 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 Department of Defense. The institution of Dr. Standaert has received research support from National Institutes of Health. 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 Speaker with Case Western Reserve. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Consultant with California Pacific Medical Center. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Course Instructor with International Parkinson Disease and Movement Disorders Society. 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 received personal compensation in the range of $500-$4,999 for serving as a Consultant with Parkinson Study Group. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Speaker with UCSD. Dr. Standaert has received personal compensation in the range of $500-$4,999 for serving as a Reviewer with Warren Alpert Foundation. 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.
Jason L. Aldred, MD, FAAN (Selkirk Neurology) Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Boston Scientific. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Abbvie. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan . Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Quadralynx. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Adamas. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Allergan. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Boston Scientific. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for TEVA. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Medtronic. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for US World Meds. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Arete Neuroscience, PLLC. The institution of Dr. Aldred has received research support from Biogen . The institution of Dr. Aldred has received research support from Abbvie. The institution of Dr. Aldred has received research support from Atara. The institution of Dr. Aldred has received research support from Takeda. The institution of Dr. Aldred has received research support from Merz. The institution of Dr. Aldred has received research support from AstraZeneca. The institution of Dr. Aldred has received research support from Neurocrine. The institution of Dr. Aldred has received research support from Aptinyx. The institution of Dr. Aldred has received research support from Cerevance. The institution of Dr. Aldred has received research support from Boston Scientific . The institution of Dr. Aldred has received research support from Parkinson Foundation . The institution of Dr. Aldred has received research support from Roche. The institution of Dr. Aldred has received research support from Theravance. The institution of Dr. Aldred has received research support from Triplet Therapeutics. The institution of Dr. Aldred has received research support from UCB. The institution of Dr. Aldred has received research support from Cerevel . The institution of Dr. Aldred has received research support from Sage Therapeutics. The institution of Dr. Aldred has received research support from Annovis. The institution of Dr. Aldred has received research support from Biovie. The institution of Dr. Aldred has received research support from Athira. The institution of Dr. Aldred has received research support from IRL. The institution of Dr. Aldred has received research support from NeuroDerm.
Marieta Anca-Herschkovitsch, MD (Edith Wolfson Medical Center- Holon-Israel) Marieta Anca-Herschkovitsch, MD has nothing to disclose.
Thomas L. Davis, MD Dr. Davis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Davis 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 Parkinson Foundation.
No disclosure on file
Norbert Kovacs Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie.
Mustafa S. Siddiqui, MD, FAAN Dr. Siddiqui has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Boston Scientific Neuromodulation. Dr. Siddiqui 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. Siddiqui has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for United States Department of Justice. The institution of Dr. Siddiqui has received research support from Boston Scientific Neuromodulation. The institution of Dr. Siddiqui has received research support from Abbvie. Dr. Siddiqui has received research support from Michael J. Fox Foundation. The institution of Dr. Siddiqui has received research support from National Institute of Health .
No disclosure on file
Mihaela A. Simu, MD, PhD (University of Medicine and Pharmacy Timisoara) Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis PHarma . Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Romania. Dr. Simu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for ABBVIE. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for ABBVIE. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for ABBVIE. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for TEVA. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi Romania. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi Romania. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Ipsen . Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Bayer. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for ABBVIE. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for UCB. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis Pharma. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Ipsen. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Johnson &Johnson. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche . Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofy Romania. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for ABBVIE. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi Romania. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis. Dr. Simu has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Abbvie . Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Abbvie. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Johnson&Johnson. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche. Dr. Simu has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Simu has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Johnson & Johnson . Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Abbvie. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for UCB. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merck. Dr. Simu has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Ewopharma A G. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Ipsen. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis. Dr. Simu has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Ipsen.
Lars Bergmann, MD (Abbvie GmbH & Co) Lars Bergmann has received personal compensation for serving as an employee of Abbvie. Lars Bergmann has stock in Abbvie.
No disclosure on file
Kallol R. Chaudhuri, MD, FRCP Dr. Chaudhuri has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie, Acadia, GSK, Scion, Britannia , Lobsor. Dr. Chaudhuri has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie, Britannia, Scion, Sunovion, UCB, . Dr. Chaudhuri has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie, Britannia, UCB, Zambon. Dr. Chaudhuri 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 NPJ PD journal. The institution of Dr. Chaudhuri has received research support from Britania Pharmaceuticals, AbbVie, UCB, GKC, Bial, Aacdemic grants: EU, IMI EU, Horizon 2020, Parkinson's UK, NIHR, PDNMG, EU (Horizon 2020), Kirby Laing Foundation, NPF, MRC, Wellcome Trust.