ELEVATE-PD
(2025)Objective
To evaluate the real-world efficacy and safety of switching to CREXONT (carbidopa and levodopa extended-release capsules) in adults with moderately severe Parkinson's disease experiencing motor complications such as OFF periods and dyskinesia despite being on a stable dose of oral levodopa-based regimen
Study Summary
• Full enrollment of ~220 participants pending; 13-14 month follow-up planned
Intervention
CREXONT (carbidopa and levodopa) extended-release capsules - a novel mucoadhesive polymer formulation designed to optimize levodopa delivery
Inclusion Criteria
Adults with moderately severe Parkinson's disease experiencing motor complications (OFF periods and dyskinesia) despite being on stable dose of oral levodopa-based regimen
Study Design
Arms: Single-arm open-label study evaluating switch to CREXONT from various prior therapies (IR CD/LD, IR CD/LD+COMT inhibitor, or Rytary)
Patients per Arm: 220 planned total enrollment (55 patients in interim analysis)
Outcome
• Reductions in daily Off time: -2.83 hours (IR CD/LD), -2.36 hours (IR CD/LD+COMT), -2.57 hours (Rytary)
• Improvements in MDS-UPDRS total scores: -14.2, -4.1, and -13.9 points respectively
• TEAEs were generally mild to moderate; most common (≥3%): nausea (5.5%), falls (3.6%), dizziness (3.6%), UTI (3.6%)
Bottom Line
Interim 6-week results from the ELEVATE-PD Phase 4 study demonstrate that switching to CREXONT significantly increases daily Good On time (1.8-3.13 hours), reduces OFF time (2.36-2.83 hours), and improves motor symptom control across patients switching from various oral carbidopa/levodopa therapies, with generally mild to moderate adverse events.
Major Points
- CREXONT uses novel mucoadhesive polymer technology to provide the longest-lasting levodopa plasma levels of any oral CD/LD therapy available
- Switching to CREXONT resulted in substantial increases in daily Good On time ranging from 1.80 to 3.13 hours depending on prior therapy
- Reductions in daily OFF time were consistent across all prior therapy groups (2.36-2.83 hours)
- MDS-UPDRS total scores improved significantly with reductions of 4.1 to 14.2 points
- Safety profile was favorable with most adverse events being mild to moderate in severity
Study Design
- Study Type
- Open-label, single-arm, switch study
- Randomization
- No
- Blinding
- Open-label
- Sample Size
- 220
- Follow-up
- 13-14 months with 10 clinical visits
- Countries
- United States
Primary Outcome
Definition: Change in daily Good On time from baseline after switching to CREXONT at 6 weeks
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| +3.13 hours (from IR CD/LD), +2.31 hours (from IR CD/LD + COMT), +1.80 hours (from Rytary) | - |
Limitations & Criticisms
- Open-label design without placebo control may introduce bias
- Small sample size in interim analysis, particularly for the COMT inhibitor subgroup (n=6)
- Short follow-up duration at interim analysis (6 weeks)
- Single-arm design prevents direct comparative effectiveness assessment
- No information provided on exclusion criteria or patient selection process
- Long-term safety and durability of response not yet established
Citation
Poster #92, Parkinson's Study Group Annual Meeting, San Diego, December 5, 2025