Long-term safety of continuous levodopa/carbidopa infusion with ND0612: Results from the ongoing BeyoND study
Stuart Isaacson1, Tanya Simuni2, Laurence Salin3, Ryan Case3, Liat Adar3, Nissim Sasson3, Tami Yardeni3, Werner Poewe4
1Parkinson's Dis & Mov Dis Ctr of Boca Raton, 2Northwestern University Feinberg School of Medicine, 3NeuroDerm, 4Medical University Innsbruck
To report cumulative data from the ongoing BeyoND study (NCT02726386) beyond 1 year.
Primary safety data show that subcutaneous levodopa/carbidopa infusion with ND0612 is generally safe up to 1 year of treatment. The study has been extended to 102 months, and some patients have now entered their 6th year of treatment.
This open-label safety study is conducted in PD patients (aged >30 years, Hoehn & Yahr Stage ≤3 during ON) taking ≥4 levodopa doses/day and ≥1 other PD medication and experiencing ≥2 hours of OFF time/day with predictable early-morning OFF periods. Patients were assigned to receive ND0612 for a regimen of either 16-hours/day or 24-hours/day. Patients who completed the 1-year study could continue into the extension study for up to 102 months of treatment.
Of the 214 enrolled patients, 120 completed the first year and 114 continued into the extension period. As of May 2021, 64 patients were still in the study, with a treatment duration of up to 4.6 years. The main reasons for treatment discontinuation over the whole study were infusion site reactions (ISR)/consent withdrawn due to ISR (17.7% of patients), followed by lack of efficacy (14.5%) and other treatment-emergent adverse events (TEAEs) (12.1%). Cumulative safety data showed that 73% of patients had ≥1 TEAE. Treatment-related serious adverse events occurred in 5.6% of patients. The most frequent TEAEs were ISRs such as nodules, hematoma, infection, pain, and eschar, which accounted for 486/640 related TEAEs and were generally reversible and manageable. The most common systemic TEAEs were fall (16.4%), urinary tract infection (13.1%), and nausea (10.3%).
ND0612 infusion was found to be safe, with generally mild to moderate local TEAEs that were reversible and manageable. There were no major differences in safety between the 16- and 24-hour regimens. Systemic safety was typical for PD patients treated with levodopa/carbidopa.