Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease
Summary
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study measures the efficacy, safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) \[LD/CD\] in advanced PD participants to achieve reduction in motor fluctuations. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's Disease. Adult participants with advanced PD will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 80 sites across the world. In one arm, participants will receive ABBV-951 solution as a continuous infusion under the skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules containing LD/CD tablets. The treatment duration is 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
Timeline
- Start
- 2020-10-19
- Primary completion
- 2021-09-29
- Completion
- 2021-09-29
Outcome
Met primary endpoint
paper Compared with levodopa-carbidopa, foslevodopa-foscarbidopa showed a significantly greater increase in on time without troublesome dyskinesia PMID 36402160 ↗
registry analysis (superiority test); LD/CD + Placebo for ABBV-951 vs ABBV-951 + Placebo for LD/CD; p = 0.0083; Least Squares (LS) Mean of Difference 1.75 NCT04380142 ↗
release “The NDA is based primarily on data from the M15-736 study, a Phase 3 randomized, double-blind, double-dummy, active-controlled study, which demonstrated statistically superior efficacy” abbvie.com ↗
Publications
- Antonini A, Bergmans B, Kern DS, Gandor F, Nishikawa N, Standaert DG, Fritz B, Gupta R, Nozaki T, Shah MB, Bergmann L, Kimber T. Foslevodopa/Foscarbidopa in Younger Patients Earlier Within Advanced Parkinson's Disease: Post Hoc Analysis of a Randomized Trial. Neurol Ther. 2026 Feb;15(1):309-324. doi: 10.1007/s40120-025-00856-1. Epub 2025 Dec 1.
- 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.
- Soileau MJ, Aldred J, Budur K, Fisseha N, Fung VS, Jeong A, Kimber TE, Klos K, Litvan I, O'Neill D, Robieson WZ, Spindler MA, Standaert DG, Talapala S, Vaou EO, Zheng H, Facheris MF, Hauser RA. Safety and efficacy of continuous subcutaneous foslevodopa-foscarbidopa in patients with advanced Parkinson's disease: a randomised, double-blind, active-controlled, phase 3 trial. Lancet Neurol. 2022 Dec;21(12):1099-1109. doi: 10.1016/S1474-4422(22)00400-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FOSLEVODOPA | Small molecule | — | Subcutaneous |
| Comparator | Levodopa/Carbidopa | Unknown | — | Oral |