Phase 4 Parkinson Disease Study Shows Increase in Good “On” Time After Switching to Crexont
KEY TAKEAWAYS
- Interim phase 4 ELEVATE-PD data showed increases in daily good "on" time and reductions in "off" time after participants switched to Crexont.
- Benefits were reported across prior levodopa-based treatment groups, including immediate-release carbidopa/levodopa, immediate-release carbidopa/levodopa plus a COMT inhibitor, and Rytary.
- The open-label study is ongoing, with longer-term outcomes expected from the 12-month follow-up period.
Amneal Pharmaceuticals (Bridgewater, NJ) has reported interim results from the phase 4 ELEVATE-PD study (NCT06765668) evaluating treatment with Crexont (carbidopa and levodopa; Amneal Pharmaceuticals, Bridgewater, NJ) extended-release capsules in adults with Parkinson disease (PD) and motor complications despite stable oral levodopa-based therapy. Findings from the full interim analysis population were presented at the Advanced Therapeutics in Movement & Related Disorders 2026 Congress.
ELEVATE-PD is an open-label, multicenter phase 4 study evaluating real-world efficacy and safety after switching to Crexont. The study included 232 adults with PD experiencing motor complications including off periods and dyskinesia while receiving stable oral levodopa-based regimens. The interim 6-week analysis included 214 participants with a mean age of 67.1 years.
Interim Efficacy Findings
- Participants who switched from immediate-release carbidopa/levodopa (IR CD/LD; n=156) had a 3.33-hour increase in daily good “on” time and a 3.20-hour reduction in daily “off” time.
- Participants who switched from IR CD/LD + a catechol-O-methyltransferase (COMT) inhibitor (n=17) had a 3.20-hour increase in daily good “on” time and a 2.96-hour reduction in daily “off” time.
- Participants who switched from Rytary (carbidopa and levodopa; Amneal Pharmaceuticals) extended-release capsules (n=41) had a 3.03-hour increase in daily good “on” time and a 2.4-hour reduction in daily “off” time.
- Mean Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) total scores improved by 14.6 points, 9.9 points, and 10.0 points in the IR CD/LD, IR CD/LD plus COMT inhibitor, and Rytary groups, respectively.
Among participants who switched from Rytary, mean continuous good “on” intervals increased from 3.19 hours at baseline to 6.27 hours at week 6. Mean daily motor fluctuations decreased from 5.28 at baseline to 2.98 at week 6, representing a 42.8% reduction.
Treatment-emergent adverse events were generally mild to moderate, according to Amneal. The most common adverse events reported in at least 3% of participants were dizziness (8.2%), fall (6.9%), nausea (6.5%), dyskinesia (6.5%), hallucination (3.0%), and headache (3.0%).
Crexont is an extended-release carbidopa/levodopa formulation consisting of immediate-release granules and extended-release pellets. According to Amneal, enrollment in ELEVATE-PD is complete, and participants are continuing through a 12-month follow-up period.
Source
Amneal Pharmaceuticals. Amneal announces full study population interim phase 4 ELEVATE-PD results, reinforcing previously reported benefits of Crexont in Parkinson's disease. Published June 5, 2026. Accessed June 15, 2026. https://investors.amneal.com/news/press-releases/press-release-details/2026/Amneal-Announces-Full-Study-Population-Interim-Phase-4-ELEVATE-PD-Results-Reinforcing-Previously-Reported-Benefits-of-CREXONT-in-Parkinsons-Disease/default.aspx