A Phase 1b, Prospective, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Tolerability of Multiple Oral Doses of IRL757 in Participants with Parkinson’s Disease and Apathy

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523612-37-00

Acronym

IRL757C003

Enrollment

125

Registered

2025-12-12

Start date

2026-01-23

Completion date

Unknown

Last updated

2026-01-14

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

Conditions

Parkinson's Disease and Apathy

Brief summary

Frequency, seriousness, and severity of AEs; change from baseline in physical examinations, clinical laboratory tests, vital signs, ECGs, C-SSRS, the QUIP-RS, and daytime sleepiness (ESS)

Detailed description

Change from baseline in: • NPI-C (apathy domain) • LARS

Interventions

DRUGPlacebo capsules

DRUGIRL757

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency, seriousness, and severity of AEs; change from baseline in physical examinations, clinical laboratory tests, vital signs, ECGs, C-SSRS, the QUIP-RS, and daytime sleepiness (ESS)	—

Secondary

Measure	Time frame
Change from baseline in: • NPI-C (apathy domain) • LARS	—

Countries

Bulgaria, Germany, Poland, Spain

Outcome results

None listed

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