Favorable Long-Term QOL Outcomes Reported for Novel Levodopa/Carbidopa Treatment for People with Parkinson’s

ND0612 (NeuroDerm, a Mitsubishi Tanabe Pharma Group Company, Jersey City, NJ), an investigational treatment for Parkinson disease (PD), significantly improved quality of life (QoL) outcomes for individuals with PD compared to immediate-release levodopa/carbidopa (IR-LD/CD) treatment according to study results presented at the 2024 International Congress of Parkinson’s Disease and Movement Disorders. ND0612 delivers LD/CD via self-administered continuous subcutaneous infusion. Previously reported results from the BouNDless study (NCT04006210) demonstrated that ND0612 increased “on” time without troublesome dyskinesia by 1.72 hours (95% CI, 1.08h to 2.36h; P<.0001) compared to IR-LD/CD.

The study included individuals with PD on ≥4 oral LD/CD doses/day (≥400mg/day LD) and experiencing ≥2.5h of daily “off” time who underwent a 4 to 6 week dose adjustment period with open-label IR-LD/CD followed by a 4 to 6 week conversion period with open-label ND0612. Participants then entered a 12-week double-blind treatment period in which they were randomized 1:1 to receive their optimized dose of ND0612 or IR-LD/CD. Researchers used the PD Questionaire-39 (PDQ-39) to assess the change in QoL from the start of open-label ND0612 conversion to the end of the double-blind treatment phase.

At the end of the double-blind phase, participants treated with ND0612 demonstrated an improvement in the adjusted mean change in PDQ-39 index scores (-2.1 points; 95% CI, -3.7 to -0.6) compared with no change in those treated with IR-LD/CD (0.6 points; 95% CI, -0.9 to 2.1), which resulted in a treatment difference of -2.7 points (nominal P=.014).

PDQ-39 domain analyses indicated that ND0612 treatment was favored in most PDQ-39 domains. Mean changes in PDQ-39 domains (ND0612 vs IR-LD/CD) were as follows:

• Mobility (-0.2 vs 2.4)
• Bodily discomfort (-4.3 vs -2.3)
• Cognition (-0.9 vs -0.3)
• Activities of daily living (-0.6 vs -0.1)
• Stigma (-2.6 vs -2.4)
• Social support (0.4 vs 0.7)
• Communication (2.3 vs -0.4)
• Emotional well-being (0.6 vs -1.3)