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Abstract Details

Impact of Subcutaneous Levodopa Infusion with ND0612 on Patient Reported Outcomes
Movement Disorders
S41 - Parkinson's Disease Interventions and Clinical Trials (1:36 PM-1:48 PM)
004
To evaluate the efficacy of ND0612 on patient-rated activities of daily living (ADL), and quality of life (QoL) in a phase 2 study.
ND0612 is an investigational drug-device combination that has been designed to deliver liquid levodopa/carbidopa (LD/CD; 60/7.5 mg/mL) by subcutaneous infusion in order to maintain steady, therapeutic levodopa levels and reduce motor complications in people with Parkinson’s disease (PD). Primary analyses of this Phase 2 study have demonstrated significant efficacy of ND0612 in reducing OFF time. This secondary analysis evaluated the efficacy of two ND0612 dosing regimens (R1: 24 hours infusion & R2: 14 hours daytime infusion) on patient-rated activities of daily living, and quality of life.
After one day of standard oral LD/CD therapy, 38 patients with motor fluctuations (mean age: 63.5 years; OFF-time 5.3 hours/day) were randomized to 28 days of treatment with either R1 (daily LD/CD dose: 720/90 mg) or R2 (daily LD/CD dose: 538/68mg + morning oral dose LD/CD [150/15 mg]). Patient reported outcomes included the UPDRS Part II (ADL) and PD Questionnaire (PDQ-39). Patients also self-rated their impression of improvement.
After 28 days of treatment, UPDRS ADL scores significantly improved for patients in R1 (LS mean [95%CI] reduction from baseline: -2.9[-5.4, -0.5] points, p=0.02) and trended towards improvement for R2 (-1.9[-4.2, 0.4], p=0.11). PDQ-39 scores also significantly improved for R1 (-7.51[-12.93, -2.08] p=0.008) and trended towards improvement for R2 (-3.66[-8.86, 1.54]; p=0.16). Improvements in R1 were driven by 7 out of 8 PDQ-39 scales (mobility, ADL, emotional well-being, stigma, social support, communication and bodily discomfort); the cognition scale remained unchanged. Overall, 74% of R1 patients and 53% of R2 patients self-reported improvements by 3. At Day 28, 78% of R1 and 79% of R2 patients reported improvement. 
24-hour levodopa infusion with ND0612 significantly improved patient ratings of ADL, QoL and overall clinical status.
Authors/Disclosures
Aaron Ellenbogen, DO
PRESENTER 		Dr. Ellenbogen has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for allergan. Dr. Ellenbogen has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for allergan. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for ipsen. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda.
Fabrizio Stocchi Fabrizio Stocchi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bial, Biogen, Sunovion, Lundbeck, UCB, Zambon, Chiesi, Lusofarmaco, Abbvie, Neuroderm, Kyowa, Synegile, Roche, Britannia, Sunovion, Blue Rock. Fabrizio Stocchi has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BIAL, Zambon, Biogen, Roche, Synegile, Sunovion. Fabrizio Stocchi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bial, Zambon, UCB, Kyowa, Sunovion.
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.
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 AAN interests or activities.
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.