Category: Parkinson’s Disease: Clinical Trials
Objective: To evaluate the efficacy of investigational ND0612 in reducing motor fluctuations in patients with Parkinson’s disease (PD) at different stages of disease and/or symptom severity.
Background: This phase 3 study showed that treatment with an optimized ND0612 regimen (ND0612 + immediate-release levodopa/carbidopa [IR-LD/CD]) provided an additional 1.72h (95% CI:1.08h, 2.36h) of ON-time without troublesome dyskinesia compared with IR-LD/CD (P<0.0001).
Method: A phase 3, double-blind trial (NCT04006210) was designed to compare optimized ND0612 vs optimized IR-LD/CD. Subgroups were defined according to varying thresholds for disease and/or symptom severity and analyzed separately for the primary endpoint (ON-time without troublesome dyskinesia) using analysis of covariance (ANCOVA) following multiple imputation with additional fixed factors for the subgroup variable and interaction term between the treatment group and subgroup variable.
Results: The adjusted mean (95% CI) treatment effect of ND0612 was homogeneous, with no significant between group differences across the different analyzed subgroups. Treatment effects were estimated for the following subgroups: Time since onset of motor fluctuations (1.87h vs 1.47h for ≤4 years [n=155] vs >4 years [n=104]); Time since PD diagnosis (2.16h vs 1.15h for <10 years vs [n=151] vs ≥10 years [n=108]); Hoehn and Yahr stage at screening (2.02h vs 1.38h for Stage ≤2 [n=140] vs Stage >2 [n=119]); Optimized oral levodopa dose prior to ND0612 initiation (2.01h for <700mg [n=36], 1.73h for 700-1500mg [n=188], 1.13h for 1500-2000mg [n=29], 2.54h for ≥2000mg [n=6]); Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II scores (2.17h for score ≤12 [n=87], 1.42h for 13-29 [n=167], 3.43h for ≥30 [n=5]); MDS-UPDRS Part III scores (1.93h for score ≤32 [n=95], 1.43h for 33-58 [n=132], 2.28h for ≥59 [n=32]); and OFF-time (1.16h for <5h [n=109], 1.68h for 5-7h [n=92], 2.84h for >7h [n=58]).
Conclusion: The treatment effect was homogenous across different analyzed subgroups. Findings from these analyses support improved Good ON-time for different severity stages, consistent with the overall increase of 1.72h.
To cite this abstract in AMA style:
H. Sarva, R. Dhall, L. Lopez-Manzanares, J. Kulisevsky, N. Lopes, J. Pereira, S. Isaacson. Efficacy of ND0612 in Patients at Different Stages of Disease Severity: Subgroup-Analyses From a Randomized, Active-Controlled Study in People With Parkinson’s Disease Experiencing Motor Fluctuations [abstract]. Mov Disord. 2025; 40 (suppl 1). https://www.mdsabstracts.org/abstract/efficacy-of-nd0612-in-patients-at-different-stages-of-disease-severity-subgroup-analyses-from-a-randomized-active-controlled-study-in-people-with-parkinsons-disease-experiencing-motor-fluct/. Accessed November 20, 2025.« Back to 2025 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-of-nd0612-in-patients-at-different-stages-of-disease-severity-subgroup-analyses-from-a-randomized-active-controlled-study-in-people-with-parkinsons-disease-experiencing-motor-fluct/