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Abstract Details

Evaluating the Use of Oral Anti-Parkinsonian Medication in Patients with Advanced Parkinson’s Disease Who Are Treated with Deep Brain Stimulation and Are Receiving Levodopa-Carbidopa Intestinal Gel: Study Design and Interim Results
Movement Disorders
P12 - Poster Session 12 (12:00 PM-1:00 PM)
3-012
To present study design and interim results on use of oral anti-Parkinsonian medications in advanced Parkinson’s disease (APD) patients who have a history of or current treatment with deep brain stimulation (DBS) and are receiving carbidopa-levodopa enteral suspension (CLES).
As PD progresses, oral drug regimens may become insufficient for symptom control. Patients using DBS with adjunctive oral therapy may still experience motor fluctuations over time, requiring the addition of therapies like CLES. There is a paucity of real-world data on APD patients with DBS concurrently receiving CLES.
This is a multi-center, retrospective chart review of APD patients with DBS who are treated with CLES in a routine clinical setting in the United States. Patients were included if they had ≥2 recorded visits before CLES initiation and 2 visits (6 months) follow-up after CLES initiation. Primary endpoint: Assess mean decrease from baseline of oral levodopa equivalent daily dose during a 16-hour waking day 6 months after CLES initiation. Secondary endpoints: percentage of individuals with reductions from baseline in total oral levodopa daily dose after CLES initiation, latency from CLES initiation until introduction/tapering of each PD medication, percentage of patients treated with DBS and CLES for whom CLES is monotherapy, and hours of “Off” and “On” time before and after CLES initiation.
As of 4 October 2019, 19 patients are enrolled from 6 study sites. The mean age is 68.5 ± 12.9 years. Reasons for initiating CLES include disabling motor fluctuations/"Off" periods (n=19), no longer optimized on concomitant PD medications (n=16), uncontrolled dyskinesia (n=12), reduced quality of life (n=8), refractory dystonia (n=2), psychiatric effects of DBS (n=1), cognitive impairment (n=1), other nonmotor symptoms (n=2), and other reasons (n=2).
CLES can be considered as a viable option for treating APD patients on DBS who have uncontrolled motor symptoms.
Authors/Disclosures
Jason L. Aldred, MD, FÂ鶹´«Ã½Ó³»­ (Selkirk Neurology)
PRESENTER 		Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan . Dr. Aldred has received personal compensation in the range of $0-$499 for serving as a Consultant for Quadralynx. 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 Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 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 $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Aldred has received personal compensation in the range of $500-$4,999 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 $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurocrine. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merz. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Boston Scientific. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 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 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 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 NeuroDerm. The institution of Dr. Aldred has received research support from PhotoPharma. The institution of Dr. Aldred has received research support from Lilly. Dr. Aldred has received research support from Capsida Biotherapeutics. Dr. Aldred has received research support from Teva. Dr. Aldred has received research support from Lundbeck. Dr. Aldred has received research support from Denali Therapeutics. Dr. Aldred has received research support from Intra-Cellular Therapies Inc.. Dr. Aldred has received research support from Vima Therapeutics. Dr. Aldred has received research support from Ventus Therapeutics. Dr. Aldred has received research support from Scion NeuroStim .
Fahd Amjad, MD (Georgetown University Hospital) Dr. Amjad has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for TEVA. Dr. Amjad has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Dr. Amjad has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Dr. Amjad has received personal compensation in the range of $0-$499 for serving as a Consultant for abbvie. Dr. Amjad has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Amjad has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Kyowna Kirin. Dr. Amjad has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Dr. Amjad has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for This information is included in the consultant disclosure. The institution of Dr. Amjad has received research support from Roche.
No disclosure on file
Pavnit Kukreja, PharmD (AbbVie) Dr. Kukreja has received personal compensation for serving as an employee of AbbVie. Dr. Kukreja has stock in AbbVie.
Irene Malaty, MD, FÂ鶹´«Ã½Ó³»­ (University of Florida) Dr. Malaty has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Malaty has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aevum. The institution of Dr. Malaty has received research support from Abbvie. The institution of Dr. Malaty has received research support from Revance. The institution of Dr. Malaty has received research support from Parkinson Foundation. The institution of Dr. Malaty has received research support from SAGE. The institution of Dr. Malaty has received research support from Emalex. The institution of Dr. Malaty has received research support from Acadia. Dr. Malaty has received publishing royalties from a publication relating to health care. Dr. Malaty has received personal compensation in the range of $500-$4,999 for serving as a Speaker & Center of Excellence Director with Parkinson Foundation. Dr. Malaty has a non-compensated relationship as a MAB member & Center of Excellence Directory with Tourette Association of America that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
Sotirios A. Parashos, MD, PhD (Struthers Parkinson'S Center) Dr. Parashos has received stock or an ownership interest from Abbott. Dr. Parashos has received research support from Park Nicollet Health Services. Dr. Parashos has received publishing royalties from a publication relating to health care.
Junaid H. Siddiqui, MD (Cleveland Clinic) Dr. Siddiqui has nothing to disclose.
Mustafa S. Siddiqui, MD, FÂ鶹´«Ã½Ó³»­ 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 Medtronic. The institution of Dr. Siddiqui has received research support from Boston Scientific Neuromodulation. The institution of Dr. Siddiqui has received research support from Abbvie. The institution of Dr. Siddiqui has received research support from National Institute of Health .
Jorge Zamudio, MD, MBA (Abbvie) Dr. Zamudio has received personal compensation for serving as an employee of Abbvie. Dr. Zamudio has received personal compensation for serving as an employee of Abbvie. Dr. Zamudio has received stock or an ownership interest from Abbvie .
Sandeep Thakkar, DO Dr. Thakkar has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for abbvie. Dr. Thakkar 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. Thakkar has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for neurocrine. Dr. Thakkar has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for teva. Dr. Thakkar has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for medtronic.