Actively Recruiting
Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy
Led by Integrative Research Laboratories AB · Updated on 2026-03-10
75
Participants Needed
13
Research Sites
62 weeks
Total Duration
On this page
Sponsors
I
Integrative Research Laboratories AB
Lead Sponsor
O
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 50 to 90 years with diagnosed Parkinson's disease
- Hoehn and Yahr stage 4 or less at screening
- MoCA score of 20 or greater at screening and baseline
- Meet the ISCTM definition of apathy with symptoms in at least 2 of 3 dimensions persisting at least 4 weeks
- Moderate to severe apathy based on a LARS score of at least -16 at screening and baseline
- Availability of a primary caregiver spending over 10 hours weekly to accompany participant to visits
- Stable doses of anti-Parkinson drugs, antidepressants (except prohibited), and cholinesterase inhibitors for 1 month before randomization
You will not qualify if you...
- Any active psychiatric condition such as major depressive disorder or obsessive-compulsive disorder
- MADRS score over 18 or hallucinations/psychosis score over 2
- Need for acute psychiatric hospitalization
- Recent suicidal ideation or behavior as assessed by C-SSRS
- Subthalamic stimulation less than 1 year ago or unstable parameters for 3 months
- Clinically significant impulse control disorders
- Significant kidney or liver impairment
- Communication impairments preventing participation
- Central nervous system or vascular abnormalities, seizures, or related history
- History of cancer within 5 years except certain non-active cancers
- Recent illness, surgery, or trauma within 4 weeks prior to first study drug dose
- Planned major surgery during trial
- Positive hepatitis B, C, or HIV screening
- Unstable vital signs or blood pressure above defined limits
- Prolonged QT interval or significant ECG abnormalities
- Severe allergy or hypersensitivity to IRL757 or related drugs
- Current regular nicotine use, recent illicit drug or alcohol abuse
- Use of anabolic steroids or antipsychotics
- Inability or unwillingness to stop certain medications before randomization
- Excessive caffeine intake prior to screening
- Recent blood or plasma donation
- Breastfeeding or positive pregnancy test
- Unwillingness to use birth control or abstain from reproductive activities
- Recent participation in other clinical trials
- Investigator judgment of non-compliance or medical unsuitability
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Medical Center "Galileo" OOD
Pleven, Bulgaria
Actively Recruiting
2
First University Multiprofile Hospital for Active Treatment MHAT - Neurology Clinic
Sofia, Bulgaria
Actively Recruiting
3
University Multiprofile Hospital for Active Treatment "Alexandrovska" EAD, Clinic of Neurological Diseases
Sofia, Bulgaria
Not Yet Recruiting
4
Neurologie Berlin
Berlin, Germany
Actively Recruiting
5
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany
Not Yet Recruiting
6
Centrum Medyczne NEUROMED
Bydgoszcz, Poland
Actively Recruiting
7
Neuro-Care sp. z o.o. sp. Komandytowa
Katowice, Poland
Actively Recruiting
8
NeuroKlinika Prof. Andrzej Bogucki
Lodz, Poland
Actively Recruiting
9
EuroMedis Sp. z o.o.
Szczecin, Poland
Actively Recruiting
10
Centrum Medyczne NeuroProtect
Warsaw, Poland
Not Yet Recruiting
11
Hospital de la Santa Creu i Sant Pau, Unidad de trastornos del movimiento
Barcelona, Spain
Actively Recruiting
12
Hospital General Universitario de Elche
Elche, Spain
Not Yet Recruiting
13
Hospital Universitario Ramon y Cajal
Madrid, Spain
Actively Recruiting
Research Team
J
Joakim Tedroff
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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