Category: Parkinson’s Disease: Clinical Trials
Objective: To characterize infusion site reactions (ISRs) reported as adverse events (AEs) in clinical studies of ND0612.
Background: ND0612 is an investigational, subcutaneous infusion of levodopa/carbidopa (max dose 720/90 mg/day), supplemented with oral therapies, delivered via 2 cannulas to reduce skin burden.
Method: Integrated analysis of ISRs reported as AEs in patients with Parkinson’s disease treated with a 24h regimen of ND0612 from two Phase 2 studies (NCT02577523 and NCT02726386) and one Phase 3 (NCT04006210) study. ‘Grouped preferred terms’ were defined for ISRs including nodules, hematoma, swelling, eschar, erythema, infection, and pain.
Results: This analysis included 419 patients with a mean ± SD exposure of 395 ± 471 days [max 6.2 years]. Overall, 369 (88.1%) patients reported at least one ISR-AE, including 15 (3.6%) patients with serious ISR-AEs; 49 (11.7%) patients discontinued due to an ISR. Of 2461 ISR-AEs, the most common were: nodules (1065 events, 43.3%), hematoma (815 events, 33.1%), pain (141 events, 5.7%), and infection (134 events, 5.4%). Most ISR-AEs were mild (2079 events, 84.5%); 347 (14.1%) and 34 (1.4%) were moderate or severe, respectively. Most (88.1%) cases of infusion site infection were mild-moderate in severity, with a median time to resolution of 15 days. Infusion site infection led to discontinuation in only 12 (2.9%) patients.
Conclusion: While ISRs were commonly reported as AEs, 99% of ISR-AEs were mild or moderate in severity and resolved with or without treatment. Despite the incidence of ISR events, most patients continued in the trials.
To cite this abstract in AMA style:
W. Poewe, A. Ellenbogen, N. Lopes, R. Pahwa. Characterization of Infusion Site Reactions With 24-hour Subcutaneous Infusion of ND0612 [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/characterization-of-infusion-site-reactions-with-24-hour-subcutaneous-infusion-of-nd0612/. Accessed October 7, 2024.« Back to 2024 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/characterization-of-infusion-site-reactions-with-24-hour-subcutaneous-infusion-of-nd0612/