INITIATE-LECIG: Intestinal levodopa + entacapone therapy (Lecigon®) to counteract dopaminergic desensitization and neuropsychiatric complications in Parkinson’s disease

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521048-39-00

Acronym

INITIATE-LECIG

Enrollment

150

Registered

2025-08-04

Start date

2025-10-28

Completion date

Unknown

Last updated

2025-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief summary

To show superiority of LECIG therapy compared to best medicaltreatment on “hyperdopaminergic symptoms” corresponding toSection 1 (items 2 & 4), and section 4 (all items) of the “ArdouinBehavioural Scale” between pre-interventional baseline and 6-month follow-up

Interventions

DRUGLecigon 20 mg/ml + 5 mg/ml + 20 mg/ml Gel zur intestinalen Anwendung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To show superiority of LECIG therapy compared to best medicaltreatment on “hyperdopaminergic symptoms” corresponding toSection 1 (items 2 & 4), and section 4 (all items) of the “ArdouinBehavioural Scale” between pre-interventional baseline and 6-month follow-up	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026