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

NCT05258071 | Completed Phase 2 DMC

• 1 other identifier: IRL752C003
• Study Type: interventional
• Target: 104
• Locations: 6 countries
• Sites: 37

Brief 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.

Conditions

Parkinson Disease

Keywords

Frequent fallers

Outcome Measures

Primary Outcomes (1)

• Change in falls frequency with Pirepemat compared to placebo as assessed with fall diary from baseline period (4 weeks prior to randomization) to the end of treatment.

  Falls being recorded using a paper fall diary (Patient Reported Outcome, PRO)

  Baseline to end of treatment (week 12)

Secondary Outcomes (3)

• Change in the total score of MDS-UPDRS part 2 (M-EDL) from baseline to end of full dose treatment (with pirepemat compared to placebo).

  Baseline to end of full dose treatment (week 11)

• Change in total score (Frequency*Severity) of NPI Item G (Apathy/Indifference) from baseline to end of full dose treatment (with pirepemat compared to placebo).

  Baseline to end of full dose treatment (week 11)

• Change in Caregiver distress of NPI Item G (Apathy/Indifference) from baseline to end of full dose treatment (with pirepemat compared to placebo).

  Baseline to end of full dose treatment (week 11)

Study Arms (3)

Pirepemat dose 1

EXPERIMENTAL

Pirepemat tablets, dose 1 (mg), 2 tablets t.i.d. for 84 days.

Drug: Pirepemat

Pirepemat dose 2

EXPERIMENTAL

Pirepemat tablets, dose 2 (mg), 2 tablets t.i.d. for 84 days.

Drug: Pirepemat

Placebo

PLACEBO COMPARATOR

Placebo tablets, 2 tablets t.i.d. for 84 days.

Drug: Placebo

Interventions

Pirepemat DRUG

Oral use

Also known as: IRL752

Pirepemat dose 1; Pirepemat dose 2

Placebo DRUG

Oral use

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 55-85 years of age, inclusive.
• Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease Society Brain Bank criteria.
• Montreal Cognitive Assessment (MoCA) score of ≥10 and \<26 at screening.
• A modified Hoehn \& Yahr score of ≥2.5 in "on".
• Having experienced recurrent falls during the past 3 months (based on interview with the patient and/or caregiver) and at least 2 falls during the past 4 weeks before baseline.
• On a stable regimen of anti-Parkinson's medications for at least 30 days prior to baseline, and willing to continue the same doses and regimens during study participation.
• Able to cooperate and participate in study related procedures. This includes the ability to accurately complete a fall diary. The fall diary may also be completed by a responsible caregiver. For patients meeting DSM-IV TR criteria for Parkinson's disease dementia, the fall diary should be completed by the caregiver.
• Availability of a responsible caregiver at least five days per week at least 2 hours per day. For patients meeting DSM-IV TR criteria for Parkinson's disease dementia, availability of a responsible live-in caregiver is required.
• Female patients must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea \[in questionable cases a blood sample with simultaneous follicle stimulation hormone (FSH) 25-140 IE/L and oestradiol \<200 pmol/L is confirmatory\]).
• Fertile male patients must be willing to use condom and refrain from donating sperm during the study and until 3 months after last dosing of IMP and ensure that their fertile female partners are using contraceptive methods to prevent pregnancy .
• Written informed consent for participation in the study given by the patient and the responsible caregiver.

You may not qualify if:

• Any of the following potential hepatic conditions:
• known history of alcohol abuse, chronic liver or biliary disease, with the exception of Gilbert's syndrome
• total bilirubin greater than the upper limit of the normal range (unless associated with isolated instances of suspected Gilbert's syndrome)
• alkaline phosphatase (ALP) greater than 1.5 times the upper limit of the normal range
• aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2 times the upper limit of the normal range
• history of repeated unexplained upper right quadrant abdominal pain and/or nausea, or jaundice
• A positive Hepatitis B surface antigen or a positive Hepatitis C antibody result.
• A score of 5 (wheelchair bound or bedridden) in the "on"-state on the modified Hoehn \& Yahr scale.
• Uncontrolled symptomatic orthostatic hypotension.
• Clinically significant polyneuropathy.
• Weight \<55 kg at Screening.
• Patients with current or past treatment with deep brain stimulation (DBS) or patients with previous history of stereotaxic brain surgery for PD.
• A current diagnosis of any primary neurodegenerative disorder other than idiopathic PD.
• A current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin B12 or folate deficiency) that is verified by the investigator to be the cause of dementia.
• A current diagnosis of a major depressive episode according to DSM-IV criteria.

Sponsors & Collaborators

• Integrative Research Laboratories AB: lead

Study Sites (37)

Hôpital Neurologique Pierre Wertheimer

Bron, France

Location

Hopital de la Timone

Marseille, France

Location

Hôpital Laennec - Centre d'investigation clinique de Neurologie

Nantes, France

Location

CHU Charles Nicolle

Rouen, France

Location

CHU Toulouse - Hôpital Purpan

Toulouse, France

Location

Charite Universitatsmedizin Berlin - Klinik fuer neurologie mit experimenteller neurologie

Berlin, Germany

Location

Praxis Dr.med. Christian Oehlwein Facharzt für Neurologie und Psychiatrie

Gera, Germany

Location

Universitätsmedizin Göttingen - Klinik für Neurologie

Göttingen, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, Germany

Location

Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Neurologie

Leipzig, Germany

Location

Philipps-Universitaet Marburg

Marburg, Germany

Location

Kliniken Kreis Muehldorf a. Inn

Mühldorf, Germany

Location

Universitysklinikum Münster - Klinik für neuroligie

Münster, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, Germany

Location

RKU - Universitäts- und Rehabilitationskliniken Ulm Klinik für Neurologie

Ulm, Germany

Location

Radboud Universitair Medisch Centrum (Radboudumc)

Nijmegen, Netherlands

Location

Silmedic sp. z o.o

Katowice, Poland

Location

Diamond Clinic sp. z o.o.

Krakow, Poland

Location

Krakowska Akademia Neurologii Sp. z o.o.

Krakow, Poland

Location

Pratia MCM Krakow

Krakow, Poland

Location

ETYKA Osrodek Badan Klinicznych

Olsztyn, Poland

Location

Instytut Zdrowia

Oświęcim, Poland

Location

Centrum Medyczne HCP SP Z OO

Poznan, Poland

Location

Neuro-Care Clinic

Siemianowice Śląskie, Poland

Location

RCMed

Sochaczew, Poland

Location

Centrum Medyczne NeuroProtect

Warsaw, Poland

Location

Singua Sp. z o.o.

Warsaw, Poland

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Hospital de Sant Pau

Barcelona, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital General Universitario de Elche

Elche, Spain

Location

Hospital Infanta Sofia

Madrid, Spain

Location

Hospital Universitario del Henares

Madrid, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

Institute of Neuroscience and Physiology

Gothenburg, Sweden

Location

Skane University Hospital - Division of Neurology

Lund, Sweden

Location

Karolinska Universitetssjukhuset - Neurologiska kliniken

Stockholm, Sweden

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Joakim Tedroff

  Integrative Research Laboratories AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 28, 2022
• Study Start: June 15, 2022
• Primary Completion: December 4, 2024
• Study Completion: January 9, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

SE (3); PL (11); ES (7); NL (1); FR (5); DE (10)