Subcutaneous combination therapy improves ‘good on’ time in Parkinson’s

Key takeaways:

• Treatment with the combination infusion as adjunct led to 1.72 more hours of “good on” time.
• Treatment effect of ND0612 did not differ given a range of sociodemographic factors.

Treatment with an investigational subcutaneous combination therapy for Parkinson’s disease improved ‘good on’ time by almost 2 hours per day, was safe and efficacious with treatment effect similar across a range of subgroups.

“Motor fluctuations as a symptom remain an unmet need among people living with [Parkinson’s disease] for whom oral levodopa treatment is no longer providing adequate benefit,” Nelson Lopes, MD, PharmD, senior medical director of clinical development at NeuroDerm, told Healio in an email regarding the data, which were presented at the Congress of the European Academy of Neurology.

Primary analyses from this phase 3 clinical trial of the investigational, subcutaneous infusion of levodopa/carbidopa (LD/CD) (ND0612) showed that treatment in doses of up to 720 mg/90 mg per day, supplemented with oral levodopa provided almost 2 additional hours per day of “Good On” time without troublesome dyskinesia compared with immediate-release levodopa/carbidopa (IR-LD/CD) at week 12.

Lopes and colleagues sought to offer safety and efficacy results for different subgroups of individuals with Parkinson’s disease (PD) categorized according to their baseline characteristics.

In their randomized, double-blind, active-controlled trial in those with PD who were experiencing motor fluctuations, patient subgroups were analyzed separately for “good on” time using analyses of co-variance on multiply imputed data, with additional fixed factors for the subgroup variable and interaction term between the treatment group and subgroup variable.

The influence of each subgroup factor was investigated by the interaction terms using Type III P value combined for multiple imputation.

The adjusted mean treatment effect of ND0612 for “good on” was homogeneous across the different analyzed subgroups. Occurrence of adverse events (AEs) and serious AEs were generally consistent across subgroups (age, gender, region and BMI). The most common AEs for all treated subgroups were infusion site reactions, while researchers observed no relevant differences between subgroups for AEs of particular interest, including dyskinesia, hallucinations, or falls.

“The critical finding was that the treatment effect of ND0612 was independent of gender, age, body mass index, race, region, or disease-related factors such as baseline time spent in ‘good on’ or prior oral [levodopa] dose,” Lopes told Healio.