New medication restores daily motivation
- Trial ID
- NCT07461220
- Official Title
- 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
- Goal
- New medication restores daily motivation
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- Integrative Research Laboratories AB
- Study Type
- INTERVENTIONAL
- Enrollment
- 75 participants
- Conditions
- PARKINSON DISEASE (Disorder), Apathy, Safety
- Interventions
- IRL757, Placebo
Summary For Families
The goal is to treat moderate to severe apathy in people with Parkinson's, helping restore initiative, interest, and emotional responsiveness that make daily life and relationships harder. IRL757 is an experimental oral medicine given in repeated doses and compared with placebo to test safety and tolerability; it aims to boost motivation by modulating brain neurotransmitter systems that drive goal-directed behavior, and it will be tested while participants stay on stable Parkinson and permitted antidepressant treatments. The trial is enrolling adults 50 to 90 years old with Parkinson's (Hoehn and Yahr stage up to 4), with preserved cognition (MoCA ≥ 20) and moderate to severe apathy on the Lille Apathy Rating Scale, and it requires a primary caregiver to help with visits. People with active major psychiatric illness or suicidal ideation, certain cardiac, liver, or kidney problems, recent substance or nicotine use, current antipsychotic use, pregnancy, unstable deep brain stimulation, or other medical risks are not eligible.
Locations
- Medical Center "Galileo" OOD, Pleven, Bulgaria
- First University Multiprofile Hospital for Active Treatment MHAT - Neurology Clinic, Sofia, Bulgaria
- University Multiprofile Hospital for Active Treatment "Alexandrovska" EAD, Clinic of Neurological Diseases, Sofia, Bulgaria
- Neurologie Berlin, Berlin, Germany
- Universitaetsklinikum Carl Gustav Carus, Dresden, Germany
- Centrum Medyczne NEUROMED, Bydgoszcz, Poland
- Neuro-Care sp. z o.o. sp. Komandytowa, Katowice, Poland
- NeuroKlinika Prof. Andrzej Bogucki, Lodz, Poland
- EuroMedis Sp. z o.o., Szczecin, Poland
- Centrum Medyczne NeuroProtect, Warsaw, Poland
- Hospital de la Santa Creu i Sant Pau, Unidad de trastornos del movimiento, Barcelona, Spain
- Hospital General Universitario de Elche, Elche, Spain
- Hospital Universitario Ramon y Cajal, Madrid, Spain
Frequently Asked Questions
- What is this trial testing?
- This trial is studying IRL757. The goal is to treat moderate to severe apathy in people with Parkinson's, helping restore initiative, interest, and emotional responsiveness that make daily life and relationships harder. IRL757 is an experimental oral medicine given in repeated doses and compared with placebo to test safety and tolerability; it aims to boost motivation by modulating brain neurotransmitter systems that drive goal-directed behavior, and it will be tested while participants stay on stable Parkinson and permitted antidepressant treatments. The trial is enrolling adults 50 to 90 years old with Parkinson's (Hoehn and Yahr stage up to 4), with preserved cognition (MoCA ≥ 20) and moderate to severe apathy on the Lille Apathy Rating Scale, and it requires a primary caregiver to help with visits. People with active major psychiatric illness or suicidal ideation, certain cardiac, liver, or kidney problems, recent substance or nicotine use, current antipsychotic use, pregnancy, unstable deep brain stimulation, or other medical risks are not eligible.
- Who can participate?
- Participants must be between 50 Years and 90 Years.
- Where is this trial located?
- This trial is recruiting at 13 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1/Phase 2 trial is estimated to last approximately 1 year and 2 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.