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, laboratory assessments will be taken on three occasions during the first 1-7 days after last dose (Visit 9-11). A Follow-up Visit (Visit 12) will take place 12-14 days after the last IMP dose and final laboratory assessments will be taken within 33-37 days from last IMP dose (Visit 13).
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.