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Parkinson DiseasePhase 2NCT05258071

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

A Phase 2 study testing Pirepemat in people with Parkinson Disease, run by Integrative Research Laboratories AB at 37 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Parkinson Disease
What is being tested?
Pirepemat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
37 sitesin 6 countries
Study dates
15 Jun 2022to 9 Jan 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.
  • Patient has delirium.
  • Any history of a heart condition, including prolonged QTc (>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.
  • 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.
  • History of seizures within two years of screening.
  • 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.
  • 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.
  • Creatinine clearance <30 mL/min (calculated according to the Cockroft-Gault formula).
  • Treatment with Warfarin within three months before study treatment.
  • Treatment with Amantadine within 6 weeks before study treatment.
  • Treatment with Selegiline within 6 weeks before study treatment.
  • 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.
  • Current or history of drugs of abuse according to DSM-IV criteria.
  • Any planned major surgery within the duration of the study.
  • Any other condition or symptoms preventing the patient from entering the study, according to the Investigator's judgement.

Trial locations and contacts

37 sites in 6 countries.

37 sites in 6 countries

Poland11 sites

  • Silmedic sp. z o.o

    Katowice

  • Diamond Clinic sp. z o.o.

    Krakow

  • Krakowska Akademia Neurologii Sp. z o.o.

    Krakow

  • Pratia MCM Krakow

    Krakow

  • ETYKA Osrodek Badan Klinicznych

    Olsztyn

  • Instytut Zdrowia

    Oświęcim

  • Centrum Medyczne HCP SP Z OO

    Poznan

  • Neuro-Care Clinic

    Siemianowice Śląskie

  • RCMed

    Sochaczew

  • Centrum Medyczne NeuroProtect

    Warsaw

  • Singua Sp. z o.o.

    Warsaw

Other trials in Poland

Germany10 sites

  • Charite Universitatsmedizin Berlin - Klinik fuer neurologie mit experimenteller neurologie

    Berlin

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

    Gera

  • Universitätsmedizin Göttingen - Klinik für Neurologie

    Göttingen

  • Klinische Forschung Hamburg GmbH

    Hamburg

  • Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Neurologie

    Leipzig

  • Philipps-Universitaet Marburg

    Marburg

  • Kliniken Kreis Muehldorf a. Inn

    Mühldorf

  • Universitysklinikum Münster - Klinik für neuroligie

    Münster

  • Klinische Forschung Schwerin GmbH

    Schwerin

  • RKU - Universitäts- und Rehabilitationskliniken Ulm Klinik für Neurologie

    Ulm

Other trials in Germany

Spain7 sites

  • Hospital Clinic Barcelona

    Barcelona

  • Hospital de Sant Pau

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital General Universitario de Elche

    Elche

  • Hospital Infanta Sofia

    Madrid

  • Hospital Universitario del Henares

    Madrid

  • Clinica Universitaria de Navarra

    Pamplona

Other trials in Spain

France5 sites

  • Hôpital Neurologique Pierre Wertheimer

    Bron

  • Hopital de la Timone

    Marseille

  • Hôpital Laennec - Centre d'investigation clinique de Neurologie

    Nantes

  • CHU Charles Nicolle

    Rouen

  • CHU Toulouse - Hôpital Purpan

    Toulouse

Other trials in France

Sweden3 sites

  • Institute of Neuroscience and Physiology

    Gothenburg

  • Skane University Hospital - Division of Neurology

    Lund

  • Karolinska Universitetssjukhuset - Neurologiska kliniken

    Stockholm

Other trials in Sweden

Netherlands1 site

  • Radboud Universitair Medisch Centrum (Radboudumc)

    Nijmegen

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
Pirepemat, Placebo
Keywords
Frequent fallers
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PirepematDrug

    Also called IRL752

    Oral use

  • PlaceboDrug

    Oral use

Study groups in NCT05258071
Study groupRoleWhat they receive
Pirepemat dose 1ExperimentalPirepemat tablets, dose 1 (mg), 2 tablets t.i.d. for 84 days.
Receives: Drug: Pirepemat
Pirepemat dose 2ExperimentalPirepemat tablets, dose 2 (mg), 2 tablets t.i.d. for 84 days.
Receives: Drug: Pirepemat
PlaceboPlacebo comparatorPlacebo tablets, 2 tablets t.i.d. for 84 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Falls Frequency 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). Change in falls is reported as relative fall rate (fall rate at evaluation period / fall rate at baseline period).

    The baseline period is defined as the period with complete fall diary data (for at least 4 weeks, i.e. 28 days) prior to first dose day.

    The evaluation period is defined as the last 28 days during which the participant was taking full dose treatment.

    Measured: Baseline to end of full dose treatment (up to Day 84).

Secondary outcomes (3)

  1. 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).

    The total scoring range is 0-52, where a higher score indicates more severe impact on Motor Aspects of Experiences of Daily Living (M-EDL).

    Measured: Baseline to end of full dose treatment (week 11)

  2. 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).

    The total scoring range is 1-12, where a higher score indicates a higher degree of apathy/indifference.

    The change in NPI-Apathy total score was also a key secondary endpoint, but was not considered evaluable due to > 50% missing data. The missing data is due to absence of apathy in some participants and thus no available score. Therefore, the statistical analysis will not be reported.

    Measured: Baseline to end of full dose treatment (week 11)

  3. Change in Caregiver Distress of NPI Item G (Apathy/Indifference) From Baseline to End of Full Dose Treatment (With Pirepemat Compared to Placebo).

    The scoring range is 0-5, where a higher score indicates a more severe caregiver distress.

    The change in NPI-Apathy total score was also a key secondary endpoint, but was not considered evaluable due to > 50% missing data. The missing data is due to absence of apathy and thus no available score. Therefore, the statistical analysis is not reported.

    Measured: Baseline to end of full dose treatment (week 11)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2022
  2. Study start15 Jun 2022
  3. Primary completion4 Dec 2024
  4. Study completion9 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05258071
Sponsor's protocol ID
IRL752C003
Status last verified
Jun 2026
First submitted
10 Feb 2022
Last updated
9 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pirepemat in people with Parkinson Disease, run by Integrative Research Laboratories AB at 37 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Poland, Germany, Spain, France, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Falls Frequency as Assessed With Fall Diary From Baseline Period (4 Weeks Prior to Randomization) to the End of Treatment. (time frame: Baseline to end of full dose treatment (up to Day 84).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05258071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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