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Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy

NCT07461220 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-03-10

No results posted yet for this study

Summary

This clinical trial's goal is to evaluate if the IRL757 is safe and has a good tolerability in participants with Parkinson's disease and experiencing apathy (a lack of interest or motivation). In addition, the trial is aiming to learn if IRL757 has effects on the symptoms of Parkinson's disease. Researchers will compare the effects of IRL757 to a placebo (a look-alike substance that contains no drug).

Participants who fit the study criteria will be treated with the study drug (either the active drug IRL757 or placebo) for 12 weeks and will visit the clinic at 5 defined timepoints for check-ups and tests. A follow-up call after the end of treatment will be done 4 weeks after the last study drug intake.

Conditions

  • PARKINSON DISEASE (Disorder)
  • Apathy
  • Safety

Interventions

DRUG

IRL757

IRL757 will be administered daily for 12 weeks. The study drug is available as capsules for oral administration.

DRUG

Placebo

The study drug is administered daily for 12 weeks. The placebo is available in form of capsules to be administered orally.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    collaborator INDUSTRY

  • Integrative Research Laboratories AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-18
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Bulgaria
  • Germany
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07461220 on ClinicalTrials.gov