2025 American Academy of Neurology Abstract Website

Harini Sarva¹, Michele Tagliati², Werner Poewe³, Fabrizio Stocchi⁴, Olivier Rascol⁵, Tami Yardeni⁶, Nelson Lopes⁶, Jonathan Pereira⁷, Alberto Espay⁸
¹Weill Cornell Medical Center, ²Cedars-Sinai Medical Center, Movement Disorder Program, ³Department of Neurology, Medical University Innsbruck, ⁴University San Raffaele Roma and Institute for Research and Medical Care IRCCS San Raffaele, ⁵University of Toulouse 3, University Hospital of Toulouse, INSERM; Clinical Investigation Center CIC1436 Departments of Neurosciences and Clinical Pharmacology and NS-Park/FCRIN network, ⁶NeuroDerm Ltd., ⁷Mitsubishi Tanabe Pharma America, Inc., ⁸James J and Joan A Gardner Center for Parkinson’s disease and Movement, University of Cincinnati

Objective:

Evaluate quality of life (QoL) data from the phase 3 randomized, active-controlled BouNDless study.

Background:

Pivotal data from the BouNDless study (NCT04006210) showed that treatment with investigational ND0612 provided patients with Parkinson’s disease (PD) and motor fluctuations an additional 1.72h [95% CI: 1.08h, 2.36h] of ON-time without troublesome dyskinesia compared with immediate-release levodopa/carbidopa (IR-LD/CD; P<0.0001).

Design/Methods:

Patients with PD on ≥4 oral LD/CD doses/day (≥400 mg/day LD) and experiencing ≥2.5h of daily OFF-time underwent 4-6 weeks of open-label IR-LD/CD dose adjustment followed by 4-6 weeks of open-label ND0612 conversion (+ IR-LD/CD). Patients were then randomized to 12 weeks of double-blind treatment with either their optimized regimen of ND0612 or IR-LD/CD. Change from randomization to end of double-blind treatment in QoL was assessed using the PD Questionaire-39 (PDQ-39) and 5-level EuroQoL (EQ-5D-5L) and analyzed using analysis of covariance (ANCOVA) following multiple imputation and the mixed model for repeated measures (MMRM), respectively.

Results:

At the end of the double-blind phase, improvements in PDQ-39 summary index scores achieved with the ND0612 regimen in the open-label run-in phase were maintained with ND0612 treatment compared to a return to enrollment values in the IR-LD/CD group. A mean [95% CI] treatment difference of –2.69 [–4.83, –0.55] was observed at the end of the double-blind phase favoring the ND0612 regimen (nominal P=0.014). PDQ-39 domain analyses consistently favored ND0612 treatment, mainly in mobility, bodily discomfort, cognition, and stigma. EQ-5D-5L scores showed consistent changes from randomization to end of double-blind phase; at Week 12, the mean [95% CI] treatment difference was 0.06 [0.00, 0.12] (nominal P=0.0331) favoring the ND0612 regimen.

Conclusions:

ND0612 improved QoL compared to IR-LD/CD, further supporting the clinical meaningfulness of the observed reduction in motor fluctuations from the perspective of a patient with PD.