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)
France104 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 range55 Years – 85 Years
SexALL
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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
✕. Any of the following potential hepatic conditions:
✕. known history of alcohol abuse, chronic liver or biliary disease, with the exception of Gilbert's syndrome
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.