Parkinson’s disease MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Pirepemat, 50 mg
Product Code: IRL752
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Pirepemat
Current Sponsor code: IRL752
Other descriptive name: Pirepemat x fumarate
Co
Sponsors
Integrative Research Laboratories Sweden AB (IRLAB)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 55-85 years of age, inclusive. 2. Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease Society Brain Bank criteria. 3. Montreal Cognitive Assessment (MoCA) score of =10 and =65 years) yes F.1.3.1 Number of subjects for this age range 84
Exclusion criteria
Exclusion criteria: 1. Any of the following potential hepatic conditions: a. known history of alcohol abuse, chronic liver or biliary disease, with the exception of Gilbert’s syndrome b. total bilirubin greater than the upper limit of the normal range (unless associated with isolated instances of suspected Gilbert’s syndrome) c. alkaline phosphatase (ALP) greater than 1.5 times the upper limit of the normal range d. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2 times the upper limit of the normal range e. history of repeated unexplained upper right quadrant abdominal pain and/or nausea, or jaundice 2. A positive Hepatitis B surface antigen or a positive Hepatitis C antibody result. 3. A score of 5 (wheelchair bound or bedridden) in the "on"-state on the modified Hoehn & Yahr scale. 4. Uncontrolled symptomatic orthostatic hypotension. 5. Clinically significant polyneuropathy. 6. Weight 450 ms for males and > 470 ms for females, QTcF and/or QTcB), cardiac arrhythmias, any repolarisation deficits or any other clinically significant abnormal ECG as judged by the Investigator. 13. Severe or ongoing unstable medical condition including a history of poorly controlled diabetes; obesity associated with metabolic syndrome; uncontrolled hypertension; cerebrovascular disease, or any form of clinically significant cardiac disease; renal failure, history of abnormal renal function. 14. History of seizures within two years of screening. 15. History of cancer within five years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localised bladder cancer, non-metastatic prostate cancer or in situ cervical cancer. 16. History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to pirepemat. 17. Creatinine clearance <30 mL/min (calculated according to the Cockroft-Gault formula). 18. Treatment with Warfarin within three months before study treatment. 19. Treatment with Amantadine within 6 weeks before study treatment. 20. Treatment with Selegiline within 6 weeks before study treatment. 21. Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment with less than three months between administration of last dose and first dose of IMP in this study. 22. Current or history of drugs of abuse according to DSM-IV criteria. 23. Any planned major surgery within the duration of the study. 24. Any other condition or symptoms preventing the patient from entering the study, according to the Investigator’s judgement. Where the clinical significance of an abnormal Screening test result (lab or any other tests) is considered uncertain, the test may
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of pirepemat on falls frequency as compared to placebo.;Secondary Objective: To evaluate the effects of pirepemat on Parkinson's disease motor symptoms as compared to placebo. To evaluate the effects of pirepemat on apathy as compared to placebo. Other objectives: To evaluate the effects of pirepemat on Parkinson's disease symptoms and severity as compared to placebo. To evaluate the effects of pirepemat on postural dysfunction as compared to placebo. To evaluate the effects of pirepemat on cognitive function as compared to placebo. To evaluate the safety and tolerability of pirepemat;Primary end point(s): Change in falls frequency from baseline period (1 month prior to randomisation) to the end of treatment visit as assessed by falls diary (1 month prior to dose de-escalation).;Timepoint(s) of evaluation of this end point: at every visit during the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in the total score of MDS-UPDRS part 2 (M-EDL) from baseline to Week 11. Change in total score (Frequency*Severity) and Caregiver distress of NPI Item G (Apathy/Indifference) from baseline to Week 11. Safety objective: As measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs and physical examination clinical laboratory safety tests, and ECGs.;Timepoint(s) of evaluation of this end point: From baseline to Week 11: MoCA - V1, V2, V5, V8 MDS-UPDRS - V1, V2, V5, V8 NPI - V2, V5, V8 Safety objective timepoints: every visit | — |
Countries
France, Germany, Netherlands, Poland, Spain, Sweden
Contacts
Public ContactClinical Trial Information Desk
Integrative Research Laboratories Sweden AB (IRLAB)
Outcome results
None listed