drugset / Trial / NCT05258071
A Clinical Study Evaluating Efficacy of Pirepemat on Falls Frequency in Patients With Parkinson's Disease (PD)
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2022-06-15
- Primary completion
- 2024-12-04
- Completion
- 2025-01-09
Outcome
Missed primary endpoint
registry analysis (superiority test); Pirepemat 600 mg vs Placebo; p = 0.5753; Median ratio 0.973 (95% CI 0.706 to 1.274); Ranked Relative Fall Rate MMRM NCT05258071 ↗
registry analysis (superiority test); Pirepemat 600 mg vs Placebo; p = 0.5156; Relative Fall Rate treatment/placebo 0.854 (95% CI 0.530 to 1.376); negative binomial regression NCT05258071 ↗
release “however, this effect did not reach statistical significance compared to placebo.” irlab.se ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pirepemat | Small molecule | — | Oral |