A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

Summary

The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD). This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.

Timeline

Start

2019-04-29

Primary completion

2022-08-17

Completion

2022-08-17

Publications

• Henriksen T, Martinez-Castrillo JC, Huisman MHB, Dhanani S, Peckham E, Aldred J, Bergmann L, Shah MB, Gupta R, Kukreja P, Parra JC, Fung VSC. Foslevodopa/Foscarbidopa Subcutaneous Infusion Safety and Efficacy in Patients with and Without Prior Deep Brain Stimulation. Adv Ther. 2026 Jun;43(6):2736-2751. doi: 10.1007/s12325-026-03579-3. Epub 2026 Apr 15.
• Pahwa R, Aldred J, Soileau MJ, Standaert DG, Fung VSC, Kimber T, Malaty IA, Santos-Garcia D, Carroll C, Henriksen T, Parab A, Yan CH, Facheris MF, Spiegel A, Harmer L, Zamudio J, Chaudhuri KR. Improvement in Motor Consistency and Stability with Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease: Post Hoc Analysis of Two Phase 3 Clinical Trials. Neurol Ther. 2025 Dec;14(6):2491-2506. doi: 10.1007/s40120-025-00827-6. Epub 2025 Oct 4.
• Chaudhuri KR, Facheris MF, Bergmans B, Bergquist F, Criswell SR, Jia J, Kukreja P, Mukai Y, Spiegel AM, Gupta R, Bergmann L, Pahwa R. Improved Sleep Correlates with Improved Quality of Life and Motor Symptoms with Foslevodopa/Foscarbidopa. Mov Disord Clin Pract. 2024 Jul;11(7):861-866. doi: 10.1002/mdc3.14018. Epub 2024 Mar 11.
• Aldred J, Freire-Alvarez E, Amelin AV, Antonini A, Bergmans B, Bergquist F, Bouchard M, Budur K, Carroll C, Chaudhuri KR, Criswell SR, Danielsen EH, Gandor F, Jia J, Kimber TE, Mochizuki H, Robieson WZ, Spiegel AM, Standaert DG, Talapala S, Facheris MF, Fung VSC. Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson's Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study. Neurol Ther. 2023 Dec;12(6):1937-1958. doi: 10.1007/s40120-023-00533-1. Epub 2023 Aug 26.

Drugs

Indications