NCT05258071

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

A Randomised, Placebo-controlled, Multicentre Phase IIb Study Evaluating the Efficacy of Pirepemat on Falls Frequency in Patients with Parkinson's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Integrative Research Laboratories AB · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

At the screening visit consenting patients will be screened for eligibility according to study specific inclusion/exclusion criteria within 6 weeks before start of Investigational Medicinal Product (IMP) administration. Patients will be asked to complete a fall diary for at least 4 consecutive weeks during the screening period and to be eligible for randomization, the patient should have experienced at least 2 falls during the 4 weeks preceding the baseline visit. At the baseline visit, patients will be randomized to receive one of two doses of Pirepemat (dose 1 or dose 2) or placebo t.i.d. (1:1:1). Dosing will start with half the dose for the first week of treatment and then continue with full dose until Week 11. Dosing will be de-escalated according to pre-specified schedule during the last week of study treatment, ending with the last dose on Day 84. The treatment allocation will be double-blind, i.e. it will not be disclosed to the patients, the site staff or the Sponsor. During the treatment period, patients will capture falls at home using a fall diary and changes in cognitive, postural, motor and mental functions will be assessed using the Montreal Cognitive Assessment (MoCA), Movement Disorder Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS), Neuropsychiatric Inventory (NPI) (Apathy/Indifference part), Single Leg Stance Test, Tandem walking test, and Clinician's Global Impression of Severity (CGI-S) and Improvement (CGI-I). Blood samples for pharmacokinetic (PK) analysis will be collected at visit 5 (week 6) and visit 8 (week 11). Following the last IMP dose, a safety follow-up period (including laboratory assessments at 3 instances) of approximately 1 month will take place.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Pirepemat	Oral use
DRUG	Placebo	Oral use

Timeline

• Start date: 2022-06-15
• Primary completion: 2024-12-04
• Completion: 2025-01-09
• First posted: 2022-02-28
• Last updated: 2025-01-27

Locations

37 sites across 6 countries: France, Germany, Netherlands, Poland, Spain, Sweden