IRL757 for Parkinson's (NCT07461220)
New medication to reduce apathy
- 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 to reduce apathy
- 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 trial is testing whether a new medication, IRL757, is safe and well tolerated in people with Parkinson's who have apathy, and it will also look for any effects on Parkinson's symptoms compared with a placebo. Participants take the medicine or a matching placebo by mouth for 12 weeks, visit the clinic at five set times for checks and tests, and get a follow-up phone call four weeks after the last dose. They are looking for people aged 50 to 90 with a confirmed Parkinson's diagnosis at stage 4 or earlier, who score at least 20 on a basic thinking test, meet the study’s criteria for moderate to severe apathy, can bring a primary caregiver, and have had stable Parkinson's or antidepressant medications for at least one month.
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 trial is testing whether a new medication, IRL757, is safe and well tolerated in people with Parkinson's who have apathy, and it will also look for any effects on Parkinson's symptoms compared with a placebo. Participants take the medicine or a matching placebo by mouth for 12 weeks, visit the clinic at five set times for checks and tests, and get a follow-up phone call four weeks after the last dose. They are looking for people aged 50 to 90 with a confirmed Parkinson's diagnosis at stage 4 or earlier, who score at least 20 on a basic thinking test, meet the study’s criteria for moderate to severe apathy, can bring a primary caregiver, and have had stable Parkinson's or antidepressant medications for at least one month.
- 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.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 3 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 3 chance (roughly 33%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- You will visit the clinic 5 times during a 12-week treatment period, with a follow-up call 4 weeks after the last dose.