Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50-90
SponsorIntegrative Research Laboratories AB
About this trial
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.
Eligibility criteria
Qualifiers
Male and female participants between 50 and 90 years of age, inclusive, with diagnosed Parkinson's disease according to the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's disease.
Hoehn and Yahr stage ≤ 4 at screening.
MoCA score of 20 or greater at screening and baseline.
Diminished initiative (less spontaneous and/or active than usual self; less likely to initiate usual activities such as hobbies, chores, self-care, conversation, work-related or social activities),
Disqualifiers
Any active, current psychiatric comorbidity (such as major depressive disorder, obsessive-compulsive disorder, etc)
as assessed by the MINI at screening,
as assessed by the MADRS at the baseline visit with a score > 18.
Score of > 2 in the MDS-UPDRS Part 1, Question 1.2 (hallucinations and psychosis).
Trial design
Treatments tested in this trial
- IRL757
- Placebo
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
Integrative Research Laboratories AB
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator
Source ClinicalTrials.gov