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ELEVATE-PD

Phase 4 Study Evaluating Real-World Efficacy and Safety of Switching to CREXONT in Adults with Moderately Severe Parkinson's Disease

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Year of Publication: 2025

Authors: Stuart Isaacson, MD (presented)

Journal: Presented at Parkinson's Study Group (PSG) Annual Meeting

Citation: Poster #92, Parkinson's Study Group Annual Meeting, San Diego, December 5, 2025

Link: https://investors.amneal.com/news/press-...se/default.aspx

Clinical Question

Does switching to CREXONT improve motor symptom control and reduce OFF time in Parkinson's disease patients with motor complications despite stable oral levodopa-based therapy?

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

Design

Study Type: Open-label, single-arm, switch study

Randomization:

Blinding: Open-label

Enrollment Period: Ongoing

Follow-up Duration: 13-14 months with 10 clinical visits

Centers: 0

Countries: United States

Sample Size: 220

Analysis: Interim analysis of first 55 patients at 6 weeks

Inclusion Criteria

  • Adults with moderately severe Parkinson's disease
  • Experiencing motor complications including OFF periods
  • Experiencing dyskinesia despite stable dose of oral levodopa-based regimen
  • Currently on IR CD/LD, IR CD/LD + COMT inhibitor, or Rytary

Arms

FieldCREXONT switch from IR CD/LDCREXONT switch from IR CD/LD + COMT inhibitorCREXONT switch from Rytary
InterventionCREXONT (carbidopa and levodopa) extended-release capsulesCREXONT (carbidopa and levodopa) extended-release capsulesCREXONT (carbidopa and levodopa) extended-release capsules
Duration6 weeks interim analysis, 13-14 months total6 weeks interim analysis, 13-14 months total6 weeks interim analysis, 13-14 months total

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Change in daily Good On time from baseline after switching to CREXONT at 6 weeksPrimary+3.13 hours (from IR CD/LD), +2.31 hours (from IR CD/LD + COMT), +1.80 hours (from Rytary)
Change in daily OFF timeSecondary-2.83 hours (IR CD/LD), -2.36 hours (IR CD/LD + COMT), -2.57 hours (Rytary)
Change in Good On time per doseSecondary+1.86 hours (IR CD/LD), +0.77 hours (IR CD/LD + COMT), +0.79 hours (Rytary)
Change in MDS-UPDRS total scoreSecondary-14.2 points (IR CD/LD), -4.1 points (IR CD/LD + COMT), -13.9 points (Rytary)
Treatment-emergent adverse events were generally mild to moderate and consistent with prior therapyAdverse
5.5%Adverse
3.6%Adverse
3.6%Adverse
3.6%Adverse
Adverse

Subgroup Analysis

Patients were analyzed based on their prior therapy: IR CD/LD (n=36), IR CD/LD + COMT inhibitor (n=6), and Rytary (n=11), with benefits observed across all subgroups

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

Funding

Amneal Pharmaceuticals, Inc.

Based on: ELEVATE-PD (Presented at Parkinson's Study Group (PSG) Annual Meeting, 2025)

Authors: Stuart Isaacson, MD (presented)

Citation: Poster #92, Parkinson's Study Group Annual Meeting, San Diego, December 5, 2025

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