Category: Parkinson’s Disease: Clinical Trials
Objective: 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).
Background: 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.
Method: 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.
Results: 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).
Conclusion: Treatment with ND0612 plus supplemental IR-LD/CD decreased time with troublesome dyskinesia and increased ON-time without any dyskinesia.
To cite this abstract in AMA style:
A. Ellenbogen, R. Pahwa, J. Hernández-Vara, N. Lopes, J. Pereira, A. Espay. Impact of ND0612 on Levodopa-Induced Dyskinesia in Parkinson’s Disease: Post hoc Analyses From a Randomized, Active-Controlled Study [abstract]. Mov Disord. 2025; 40 (suppl 1). https://www.mdsabstracts.org/abstract/impact-of-nd0612-on-levodopa-induced-dyskinesia-in-parkinsons-disease-post-hoc-analyses-from-a-randomized-active-controlled-study/. Accessed October 5, 2025.« Back to 2025 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/impact-of-nd0612-on-levodopa-induced-dyskinesia-in-parkinsons-disease-post-hoc-analyses-from-a-randomized-active-controlled-study/