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Abstract Details

First Results for The BeyoND Study: An open-label international, multicenter study evaluating the long-term safety of ND0612 in patients with idiopathic Parkinson’s disease
Movement Disorders
P9 - Poster Session 9 (12:00 PM-1:00 PM)
3-007
To establish the long-term safety profile of continuous subcutaneous infusion of ND0612 in Parkinson's patients experiencing motor fluctuations.
ND0612 is a carbidopa/levodopa solution which is subcutaneously, continuously infused via a pump system to reduce motor complications in patients with Parkinson’s disease.
This phase IIb, open-label, one-year safety study (NCT02726386) was conducted in adult (>30-years old) patients with a diagnosis of PD (Hoehn & Yahr ≤3 during ON) taking ≥4 levodopa doses/day and ≥1 other PD medications. Patients with ≥2 hours of OFF time per day with predictable early-morning OFF periods were included. Patients were assigned to open-label treatment with ND0612 for either 24 hours or 16 hours. Adjunct oral PD medications were taken as needed. Safety (systemic and local) and tolerability were assessed through reported treatment-emergent adverse events (TEAEs). At study end, patients could continue treatment with ND0612.
214 patients were enrolled (24-hour regimen: n=90; 16-hour regimen: n=124) at 46 sites in 8 countries. Overall, 66.4% of patients were male and the mean (±SD) age was 64.0±8.9 years, time since PD diagnosis was 9.0±4.7 years and duration of motor fluctuations was 5.3±4.2 years. The mean levodopa dose at baseline was 1028±539mg. ND0612 was well-tolerated causing manageable transient local skin reactions and no unexpected systemic TEAEs for levodopa treatment. The most common TEAEs were infusion site nodules, infusion site hematoma, and infusion site pain. Overall, less than a quarter of patients discontinued the study due to TEAEs, few had serious treatment-related TEAEs, and some have continued into their fourth year.
In this one-year study, continuous subcutaneous levodopa infusion with ND0612 was generally tolerated with no new safety concerns. Systemic TEAEs were consistent with those expected for levodopa. Local infusion site reactions were manageable.  Additional data are being collected on participants in the study extension, some are in their fourth year.
Authors/Disclosures
Stuart H. Isaacson, MD, FÂ鶹´«Ã½Ó³»­ (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.
Werner Poewe, MD (University Hospital of Neurology) Werner Poewe, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Affiris . Werner Poewe, MD has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alterity, AbbVie, BIAL, Biogen, Britannia, Lilly, Lundbeck, Neuroderm, Neurocrine, Denali Pharmaceuticals, ,Roche, Takeda, UCB and Zambon . Werner Poewe, MD has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie, Britannia, BIAL, STADA, Lundbeck, Zambon. The institution of Werner Poewe, MD has received research support from MJFF; EU Horizon programme. Werner Poewe, MD has a non-compensated relationship as a Committee member with Movement Disorder Society that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
Tanya Simuni, MD, FÂ鶹´«Ã½Ó³»­ (Northwestern University Feinberg School of Medicien) Dr. Simuni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for cadia, AcureX, Adamas, AskBio, Amneal, Blue Rock Therapeutics, Caraway Therapeutics, Critical Path for Parkinson's Consortium (CPP), Denali, Michael J Fox Foundation, Neuroderm, Sanofi, Sinopia, Roche, Takeda and Vanqua Bio. Dr. Simuni has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for of Koneksa, Neuroderm, Sanofi, UCB, AcureX, Adamas, AskBio, Biohaven, Denali, GAIN, Neuron23 and Roche. Dr. Simuni has received research support from Amneal, Biogen, Neuroderm, Prevail, Roche, and UCB and an investigator for NINDS, MJFF, Parkinson's Foundation.
Sheila Oren, MD, MBA (Neuroderm) Sheila Oren, MD, MBA has received personal compensation for serving as an employee of Neuroderm. Sheila Oren, MD, MBA has received personal compensation in the range of $0-$499 for serving as a Consultant for Neuroderm.
Ryan J. Case, PhD Dr. Case has received personal compensation for serving as an employee of NeuroDerm.
C. W. Olanow, MD Dr. Olanow has received personal compensation for serving as an employee of Clintrex Research Corporation. Dr. Olanow has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Clintrex Research Corporation. Dr. Olanow has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Chevron/Syngenta. Dr. Olanow has stock in Clintrex Research Corporation.