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Abstract Details

Impact of ND0612 on Levodopa-induced Dyskinesia in Parkinson’s Disease: Post-hoc Analyses from a Randomized, Active-controlled Study
Movement Disorders
P8 - Poster Session 8 (11:45 AM-12:45 PM)
17-013

To evaluate dyskinesia-related outcomes between optimized subcutaneously administered levodopa/carbidopa (ND0612) + immediate-release levodopa/carbidopa (IR-LD/CD) vs optimized oral IR-LD/CD in patients with Parkinson’s disease (PD).

Investigational ND0612 is under development as a subcutaneous infusion for continuous levodopa delivery to supplement oral antiparkinsonian medications for PD patients with motor fluctuations. The pivotal trial showed that treatment with an optimized ND0612 + IR-LD/CD regimen significantly reduced motor fluctuations. Here we evaluated the impact of this treatment on levodopa-induced dyskinesia.

Levodopa-treated PD patients with motor fluctuations underwent an open-label, run-in phase to establish their optimal IR-LD/CD + ND0612 regimen. Participants were then randomized to a 12-week double-blind regimen of either optimized ND0612 + placebo IR-LD/CD or IR-LD/CD + placebo ND0612. Here we present post hoc analyses for the overall population and for the subgroup of patients with ≥1h troublesome dyskinesia at ND0612 initiation.
For the overall population, ND0612 decreased ON-time with non-troublesome dyskinesia (2.5h to 2.2h) and troublesome dyskinesia (0.7h to 0.5h), whereas they increased in IR-LD/CD–treated patients (from 2.4h to 2.6h and from 0.7h to 0.9h, respectively). There was a net gain of +2.1h with ND0612 vs IR-LD/CD in ON-time without any dyskinesia at the end of the double-blind period (p<0.0001). Participants with ≥1h troublesome dyskinesia showed a change [95% CI] in troublesome dyskinesia of −1.3h [−2.1, −0.5] with ND0612 (n=26) vs −0.05h [−0.9, 0.8] with IR-LD/CD (n=22), resulting in a net reduction of −1.2h [−2.4, −0.03] (p=0.046). Upon adjustment of medication in the conversion period, the incidence of dyskinesia was low and comparable in the 2 treatment arms (2% in each arm).

Treatment with ND0612 plus supplemental IR-LD/CD decreased time with troublesome dyskinesia and increased ON-time without any dyskinesia.
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.
Rajesh Pahwa, MD, FAAN (University of Kansas Medical Center) Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ACADIA. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Insightec. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jaaz. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fasikl. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genetech. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Photopharmics. The institution of Dr. Pahwa has received research support from Abbott. The institution of Dr. Pahwa has received research support from Abbvie. The institution of Dr. Pahwa has received research support from Biogen. The institution of Dr. Pahwa has received research support from Parkinson Foundation. The institution of Dr. Pahwa has received research support from Roche. The institution of Dr. Pahwa has received research support from Sage. The institution of Dr. Pahwa has received research support from Sun Pharma. The institution of Dr. Pahwa has received research support from Theravance. The institution of Dr. Pahwa has received research support from Neuroderm. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Blue Rock. The institution of Dr. Pahwa has received research support from Cerevance. The institution of Dr. Pahwa has received research support from Fasikl. The institution of Dr. Pahwa has received research support from Scion. The institution of Dr. Pahwa has received research support from UCB. The institution of Dr. Pahwa has received research support from Ono. The institution of Dr. Pahwa has received research support from Intra-cellular Therapies. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Michael J Fox Foundation . The institution of Dr. Pahwa has received research support from Neuron 23. The institution of Dr. Pahwa has received research support from Roche.
jorge hernandez-vara, MD, PhD Dr. hernandez-vara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. hernandez-vara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BIAL. Dr. hernandez-vara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for STADA. Dr. hernandez-vara has stock in SENSE4CARE. The institution of Dr. hernandez-vara has received research support from SPANISH HEALTH MINISTER.
Nelson F. Lopes Dr. Lopes has received personal compensation for serving as an employee of Neuroderm.
Alejandro Salah, MD, PhD, MBA, MHA Dr. Salah has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma.
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.