A Clinical Study Evaluating Efficacy of Pirepemat on Falls Frequency in Patients with Parkinson's… (NCT05258071) | Clinical Trial Compass
CompletedPhase 2
A Clinical Study Evaluating Efficacy of Pirepemat on Falls Frequency in Patients with Parkinson's Disease (PD)
France, Germany, Netherlands104 participantsStarted 2022-06-15
Plain-language summary
This is a Phase 2b study investigating the efficacy and safety of pirepemat as adjunct therapy on falls frequency in patients with Parkinson disease. Pirepemat is taken for 84 days.
Who can participate
Age range
55 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female 55-85 years of age, inclusive.
. Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease Society Brain Bank criteria.
. Montreal Cognitive Assessment (MoCA) score of ≥10 and \<26 at screening.
. A modified Hoehn \& Yahr score of ≥2.5 in "on".
. Having experienced recurrent falls during the past 3 months (based on interview with the patient and/or caregiver) and at least 2 falls during the past 4 weeks before baseline.
. On a stable regimen of anti-Parkinson's medications for at least 30 days prior to baseline, and willing to continue the same doses and regimens during study participation.
. Able to cooperate and participate in study related procedures. This includes the ability to accurately complete a fall diary. The fall diary may also be completed by a responsible caregiver. For patients meeting DSM-IV TR criteria for Parkinson's disease dementia, the fall diary should be completed by the caregiver.
. Availability of a responsible caregiver at least five days per week at least 2 hours per day. For patients meeting DSM-IV TR criteria for Parkinson's disease dementia, availability of a responsible live-in caregiver is required.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in falls frequency with Pirepemat compared to placebo as assessed with fall diary from baseline period (4 weeks prior to randomization) to the end of treatment.