Continuous levodopa/carbidopa infusion had a good safety profile and was well-tolerated longer-term in patients with Parkinson’s disease and motor fluctuations.
Continuous levodopa/carbidopa infusion (ND0612) showed a favorable safety profile and was well-tolerated over the longer term in patients with Parkinson’s disease (PD) who have motor fluctuations. Patients achieved clinically relevant increases in ON-time without troublesome dyskinesia, as well as decreases in OFF-time.
These were the main conclusions drawn from the 3-year data of the BeyoND study, which evaluates the long-term safety of ND0612 in patients with PD who experience 2 or more hours a day of OFF-time. The results confirmed the previously published positive outcomes after 1 year.
In this study, 214 participants entered the trial; 120 completed 1 year and 114 participants entered the extension study (OLE). The 3-year results were presented by Aaron Ellenbogen, DO. According to Dr. Ellenbogen, 94 participants (82.5%) completed 2 or more years and 76 (80.1%) completed 3 or more years of ND0612 treatment; some participants were already in their seventh year. Of the 20 participants who discontinued, 10 withdrew consent and four experienced intolerable side effects.
At baseline, participants who entered the extension phase had a mean (±SD) OFF-time of 5.6 (±2.9) hours, and the mean Unified Parkinson’s Disease Rating Scale (UPDRS) motor score was 26.1 (±12.8). Half of the participants (N=57) had a modified Hoehn and Yahr Scale score of 2; 27 (23.7%) had a score of 2.5 and 30 (26.3%) had a score of 3. The systemic safety profile was comparable to expected profiles for an LD/CD product, according to Dr. Ellenbogen. In year 1 of the OLE (N=114), 73.7% of participants had drug-related AEs; in year 2, this percentage dropped to 36.9%, and in year 3, it was 39.4%.
Infusion site reactions were common, mostly mild, and rarely led to discontinuation, Dr. Ellenbogen said. Reactions also tended to decrease over time, from 60.5% of patients in year 1 to 26.1% in year 2 and 27.7% in year 3. The incidence of infusion site infection decreased from 19.3% in year 1 to 9.9% in year 2 and 11.7% in year 3. Dyskinesia was seen in 3.5% of participants in year 1, no participants in year 2, and 1.1% in year 3.
Exploratory efficacy results in 45 participants at month 36 showed a mean reduction in OFF-time of -2.81 hours. The increase in Good ON-time was 2.79 hours.
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