Objective: To evaluate the efficacy and safety of Hybridopa A and Hybridopa B, combination products of immediate-release carbidopa/levodopa (IR CD/LD) and therapeutic mobile applications, in adults with idiopathic Parkinson’s disease (PD) on a stable dose of CD/LD without clinically significant motor fluctuations.

Background: Many individuals with PD treated with CD/LD continue to experience residual motor and non-motor symptoms that impair daily functioning and quality of life. In the Phase 2a BUTTERFLY trial, a 3-week use of a multimodal digital intervention (DopApp) added to standard levodopa therapy demonstrated statistically significant and clinically meaningful improvements in motor and non-motor outcomes. These results support confirmatory evaluation of a hybrid therapeutic approach integrating optimized IR CD/LD with structured digital protocols in a longer, well-controlled study.

Method: The EAGLE study is a 12-week, randomized, double-blind Phase 3 trial enrolling approximately 270 adults aged 30–80 years with idiopathic PD (Hoehn and Yahr stages 1–3) who are levodopa responsive and maintained on a stable levodopa treatment regimen. Participants with clinically significant motor fluctuations or dyskinesias are excluded. At baseline, all participants will receive an IR CD/LD formulation at the same levodopa equivalent dose as their regimen prior to the trial, and will be randomized 1:1 to Hybridopa A (IR CD/LD plus digital protocol A) or Hybridopa B (IR CD/LD plus digital protocol B).  The primary endpoint is the change from baseline to Week 12 in the combined MDS-UPDRS Parts II+III score. Key secondary endpoints include changes in MDS-UPDRS Part II and Part III scores, Patient Global Impression of Severity, Beck Depression Inventory-II, and Parkinson’s Disease Questionnaire-39 scores.

Results: Efficacy will be determined by improvement in motor function and activities of daily living at Week 12 and changes in patient-reported outcomes. Safety will be assessed by adverse events, tolerability, and discontinuation.

Conclusion: The EAGLE study is designed to generate confirmatory evidence for a hybrid therapeutic approach that could broaden treatment options and influence future standards for comprehensive symptom management in Parkinson’s disease

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MDS Abstracts - https://www.mdsabstracts.org/abstract/eagle-protocol-for-a-phase-3-study-to-evaluate-the-efficacy-and-safety-of-two-mobile-applications-combined-with-immediate-release-cd-ld-for-the-management-of-idiopathic-parkinsons-disease/