drugset / Trial / NCT05258071

A Clinical Study Evaluating Efficacy of Pirepemat on Falls Frequency in Patients With Parkinson's Disease (PD)

NCT05258071 ↗

Phase 2 Completed 104 enrolled Integrative Research Laboratories AB
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

EvaluationDrugModalityDoseRoute
Subject Pirepemat Small molecule — Oral

Indications