Idiopathic Parkinson DiseasePhase 1NCT05832775

Study to Assess the Safety of MRx0029 or MRx0005 Compared to Placebo, in People With Parkinson's

A Phase 1 study testing MRx0029 and MRx0005 in people with Idiopathic Parkinson Disease, run by 4D pharma plc.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Idiopathic Parkinson Disease
What is being tested?: MRx0029 and MRx0005
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: May 2022to Apr 2023
Phase: Phase 1
Are there results?: None posted in the registry

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 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of idiopathic PD according to the UKPDS-BBCDC
Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions.
Male or female participants age ≥ 40 or ≤ 85 years of age.
BMI ≥ 18.0 to ≤ 35.0 kg/m2, inclusive, where BMI (kg/m2) is calculated by body weight (kg)/height2 (m2).
Hoehn \& Yahr (H\&Y) Stage I to II (if on levodopa the participant should be classed as Stage I to II in an 'ON' period)
A documented diagnosis of PD

Show all 10Show fewer

If presently being medically treated for PD, they should be on a stable dose unchanged within the 30 days prior to screening and not be expected to require any adjustments or start any new PD medication for the duration of their participation in the study.
No clinically relevant abnormal medical history, or abnormal findings on physical examination, vital signs, ECG, or laboratory tests
Has been fully vaccinated with an approved Covid-19 vaccine
Male and female participants are eligible to enter provided they follow the contraception criteria for the study.

Who cannot join

Participants with significant motor fluctuations
Parkinson syndromes
Known carriers of familial PD genes
History and/or current presence of clinically significant CNS disease other than PD.
Montreal Cognitive Assessment (MoCA) <24
No history of spontaneous constipation since diagnosis

Show all 35Show fewer

Participants who are <70% compliant to completing their e-daily assessed at Treatment Period 1, Day 1.
Are non-compliant with prescribed PD medication
Comorbidities that have not been optimally controlled for the last 3 months prior to screening.
Participants with known Type 1 or Type 2 diabetes mellitus or a HbAlc result. indicative of diabetes/pre-diabetes.
Have an active or recent malignant disease or any concomitant end-stage organ disease.
Participants with known GI fistula, feeding tubes, or inflammatory bowel disease.
Participants who had recent abdominal surgery (6 months before the screening visit).
Participants with GI disease resulting in an inability to take oral medication, malabsorption syndrome, prior surgical procedures affecting absorption, uncontrolled GI disease
Participants with conditions that may increase the risk of generalized peritonitis
Dysphagia to the extent it would affect the participant's ability to swallow the IMP during their participation
Anything which in the opinion of the investigator prevents the participant being able to give urine or stool samples.
Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus antibodies (anti HIV) 1/2 at screening.
Previous history or current active tuberculosis (TB), or taking medication for the treatment of TB.
Participant has severe or moderate renal impairment (defined as creatinine clearance <60 mL/min) estimated using Cockcroft-Gault Equation.
Participants taking anti-cholinergic medication or amantadine.
Participants with congenital, acquired or drug-related immunodeficiency.
Participants who use systemic corticosteroids or systemic immunosuppressants for any reason within 30 days prior to screening.
Participants taking ad hoc anti-inflammatory medication within 30 days of screening are excluded.
Participants taking dopamine antagonists, such as the neuroleptics or metoclopramide are excluded.
Participants who are allergic to the following antibiotics: amoxicillin/clavulanic acid, ampicillin, chloramphenicol, clarithromycin, clindamycin, imipenem, or metronidazole.
Participants who have completed a course of systemic antibiotics in the 30 days prior to screening.
Participants using prebiotic and probiotic supplements
Donation or loss of 500 mL blood during the 3 months before screening.
Current or history of alcohol or drug abuse or other dependence (except nicotine dependence) within the last 2 years prior to IMP administration.
Positive urine drug screen (if not due to concomitant medication) or alcohol breath test.
Receipt of a positive COVID-19 test result
Participant is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or study drug(s), or participant receiving other investigational agent(s).
Received a live vaccine within 4 weeks prior to enrolling in this trial or plan for any such vaccination during the trial or within 4 months after study drug administration. Administration of inactivated vaccines (for example, inactivated influenza vaccines is allowed.).
Legal incapacity or limited legal capacity.

About this study

Official title: A First-in-human, Double-blind, Placebo-controlled, Multicentre, Cross-over, Phase I Study to Assess Safety and Tolerability of Repeat Oral Administrations of MRx0029 OR MRx0005 in Adult Participants With Idiopathic Parkinson's Disease

This is a first-in-human study to evaluate the safety and tolerability of repeat oral administrations of MRx0029 (20 participants) or MRx0005 (20 participants) in participants diagnosed with idiopathic PD. Participants who are successfully screened will be randomized to 1 of 2 treatment sequences (TS) within their cohort (10 participants per sequence). Each treatment period will be separated by a washout period of 4 to 6 weeks.

Cohort A Treatment Sequence 1: MRx0029 (1 capsule bid) for 4 weeks; 4-to 6-week washout period; placebo (1 capsule bid) for 4 weeks.

Cohort A Treatment Sequence 2: Placebo (1 capsule bid) for 4 weeks; 4-to 6-week washout period; MRx0029 (1 capsule bid) for 4 weeks.

Cohort B Treatment Sequence 1 MRx0005 (1 capsule bid) for 4 weeks; 4- to 6-week washout period; placebo (1 capsule bid) for 4 weeks.

Cohort B Treatment Sequence 2: Placebo (1 capsule bid) for 4 weeks; 4-to 6-week washout period; MRx0005 (1 capsule bid) for 4 weeks

Cohort A will be randomized first and when all participants have been randomized to Cohort A, Cohort B enrollment will begin.

Read the detailed description

There will be a total of 10 visits which will include a screening visit, 8 treatment period visits, and a Follow-up Visit. Three telephone calls will be made during the study to assess the participant's health status and confirm eDiary compliance. Participants will be screened for eligibility between Day -28 to Day -2 (Visit 1, screening). Informed consent will be obtained before performing any study-related procedures.

Following randomization, participants will be provided with enough study medication to administer at home for 4 weeks (+/-2 days). The participants will discontinue treatment for 4 to 6 weeks. The participants will return to the site for the second period of study treatment and will again be provided with enough study medication to administer at home for 4 weeks (+/-2 days).

Frequency of the AEs monitored throughout the study, and changes in laboratory values, vital signs, ECGs, and physical examinations will be assessed at the beginning and at the end of each treatment period.

Gut permeability will be assessed with administration of a sugar solution and subsequent 24 hour urine collection.

During the study, participants will report their daily bowel habits, including stool consistency, with the use of an electronic diary (the Bristol Stool Chart diary). The participants will also provide a stool sample on Day 1 and Day 29 of each treatment period and at the Follow-up Visit.

PD symptoms will be assessed with the use of MDS-UPDRS and MDS-NMS to confirm that MRx0005 and MRx0029 do not adversely impact a participant's Parkinson's symptoms.

Participants will report their dietary habits by filling out a Food Frequency Questionnaire at the clinic visits beginning (Day 1) and at the end of each treatment period, and at the Follow-up Visit.

For the participants who are on stable immediate release formulations of levodopa, PK of levodopa will be assessed at the beginning (Day 1, prior to the first IMP dosing) and at the end (Day 29) of each treatment period.

Fecal microbiome, as well as plasma/serum, fecal and urine biomarkers will be assessed, on Day 1 prior to the start of each treatment (baseline) period and at the end of each treatment period (Day 29), and at the Follow-up Visit.

Participants will undergo a 4- to 6-week washout between treatment periods. Approximately 4 to 6 weeks after their second EOT visit, the participants will attend the clinic for their Follow-up Visit.

Conditions: Idiopathic Parkinson Disease
Being tested: MRx0029, MRx0005
Keywords: Microbiome
Medical subject headings: Parkinson Disease

What participants receive

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

MRx0029Biological
Megasphaera massiliensis MRx0029 (Treatment A) and Placebo
MRx0005Biological
Parabacteroides distasonis MRx0005 (Treatment B) and Placebo

Study groups in NCT05832775
Study group	Role	What they receive
MRx0029 Treatment Sequence 1	Experimental	Patients will receive MRx0029 in the first treatment period and then placebo in the second treatment period Receives: Biological: MRx0029
MRx0029 Treatment Sequence 2	Experimental	Patients will receive placebo in the first treatment period and then MRx0029 in the second treatment period Receives: Biological: MRx0029
MRx0005 Treatment Sequence 1	Experimental	Patients will receive MRx0005 in the first treatment period and then placebo in the second treatment period Receives: Biological: MRx0005
MRx0005 Treatment Sequence 2	Experimental	Patients will receive placebo in the first treatment period and then MRx0005 in the second treatment period Receives: Biological: MRx0005

What is being measured

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

Incidence of treatment-emergent adverse events (TEAEs)
Number of TEAEs after 4-weeks of treatment with MRx0029 vs 4-weeks of placebo in participants with idiopathic PD
Measured: Baseline to Follow-up Visit (up to 24 weeks)
Incidence of treatment-emergent adverse events (TEAEs)
Number of TEAEs after 4 weeks of treatment with MRx0005 vs 4-weeks of placebo in participants with idiopathic PD
Measured: Baseline to Follow-up Visit (up to 24 weeks)
Incidence of Serious Adverse Events (SAEs)
Number of SAEs after 4 weeks of treatment with MRx0029 vs 4-weeks of placebo in participants with idiopathic PD
Measured: Baseline to Follow-up Visit (up to 24 weeks)
Incidence of Serious Adverse Events (SAEs)
Number of SAEs after 4 weeks of treatment with MRx0005 vs 4-weeks of placebo in participants with idiopathic PD
Measured: Baseline to Follow-up Visit (up to 24 weeks)

Timeline

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

May 2022Apr 2023

First posted27 Apr 2023
Study startMay 2022 (estimated)
Primary completionApr 2023 (estimated)
Study completionApr 2023 (estimated)

Why it stopped: Sponsor insolvency

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05832775
Sponsor's protocol ID: INNOVATE-LBP 1.0
Status last verified: Apr 2023
First submitted: 8 Mar 2022
Last updated: 27 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
Recruiting
MediPD: An Online Mediterranean Diet Program for People Living With Parkinson's Disease
Parkinson Disease, Idiopathic
Recruiting
Video-oculography and Parkinson's Disease
Parkinson Disease, Idiopathic

All Idiopathic Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A First-in-human, Double-blind, Placebo-controlled, Multicentre, Cross-over, Phase I Study to Assess Safety and Tolerability of Repeat Oral Administrations of MRx0029 OR MRx0005 in Adult Participants With Idiopathic Parkinson's Disease
ClinicalTrials.gov ID: NCT05832775
Acronym / sponsor ID: INNOVATE-LBP 1.0
Conditions: Idiopathic Parkinson Disease
Keywords: Microbiome
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Sponsor insolvency
Enrolment: 0 participants (actual)
Lead sponsor: 4D pharma plcIndustry (pharma, biotech, devices)
Collaborators: Labcorp Corporation of America Holdings, Inc, ICON plc
Study start: May 2022 (estimated)
Primary completion: Apr 2023 (estimated)
Study completion: Apr 2023 (estimated)
First posted: 27 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Cohort A Treatment Sequence 1: MRx0029 (1 capsule bid) for 4 weeks; 4-to 6-week washout period; placebo (1 capsule bid) for 4 weeks.

Cohort A Treatment Sequence 2: Placebo (1 capsule bid) for 4 weeks; 4-to 6-week washout period; MRx0029 (1 capsule bid) for 4 weeks.

Cohort B Treatment Sequence 1 MRx0005 (1 capsule bid) for 4 weeks; 4- to 6-week washout period; placebo (1 capsule bid) for 4 weeks.

Cohort B Treatment Sequence 2: Placebo (1 capsule bid) for 4 weeks; 4-to 6-week washout period; MRx0005 (1 capsule bid) for 4 weeks

Cohort A will be randomized first and when all participants have been randomized to Cohort A, Cohort B enrollment will begin.

Detailed description

Gut permeability will be assessed with administration of a sugar solution and subsequent 24 hour urine collection.

PD symptoms will be assessed with the use of MDS-UPDRS and MDS-NMS to confirm that MRx0005 and MRx0029 do not adversely impact a participant's Parkinson's symptoms.

Participants will report their dietary habits by filling out a Food Frequency Questionnaire at the clinic visits beginning (Day 1) and at the end of each treatment period, and at the Follow-up Visit.

Participants will undergo a 4- to 6-week washout between treatment periods. Approximately 4 to 6 weeks after their second EOT visit, the participants will attend the clinic for their Follow-up Visit.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
MRx0029 Treatment Sequence 1	Experimental	Biological: MRx0029Patients will receive MRx0029 in the first treatment period and then placebo in the second treatment period
MRx0029 Treatment Sequence 2	Experimental	Biological: MRx0029Patients will receive placebo in the first treatment period and then MRx0029 in the second treatment period
MRx0005 Treatment Sequence 1	Experimental	Biological: MRx0005Patients will receive MRx0005 in the first treatment period and then placebo in the second treatment period
MRx0005 Treatment Sequence 2	Experimental	Biological: MRx0005Patients will receive placebo in the first treatment period and then MRx0005 in the second treatment period

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Diagnosis of idiopathic PD according to the UKPDS-BBCDC
Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions.
Male or female participants age ≥ 40 or ≤ 85 years of age.
BMI ≥ 18.0 to ≤ 35.0 kg/m2, inclusive, where BMI (kg/m2) is calculated by body weight (kg)/height2 (m2).
Hoehn \& Yahr (H\&Y) Stage I to II (if on levodopa the participant should be classed as Stage I to II in an 'ON' period)

Key exclusion criteria (35 listed)

Participants with significant motor fluctuations
Parkinson syndromes
Known carriers of familial PD genes
History and/or current presence of clinically significant CNS disease other than PD.
Montreal Cognitive Assessment (MoCA) <24

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MRx0029Megasphaera massiliensis MRx0029 (Treatment A) and Placebo	Biological	MRx0029 Treatment Sequence 1, MRx0029 Treatment Sequence 2
MRx0005Parabacteroides distasonis MRx0005 (Treatment B) and Placebo	Biological	MRx0005 Treatment Sequence 1, MRx0005 Treatment Sequence 2

Primary outcome

Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline to Follow-up Visit (up to 24 weeks)
Number of TEAEs after 4-weeks of treatment with MRx0029 vs 4-weeks of placebo in participants with idiopathic PD
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline to Follow-up Visit (up to 24 weeks)
Number of TEAEs after 4 weeks of treatment with MRx0005 vs 4-weeks of placebo in participants with idiopathic PD
Incidence of Serious Adverse Events (SAEs)
Time frame: Baseline to Follow-up Visit (up to 24 weeks)
Number of SAEs after 4 weeks of treatment with MRx0029 vs 4-weeks of placebo in participants with idiopathic PD
Incidence of Serious Adverse Events (SAEs)
Time frame: Baseline to Follow-up Visit (up to 24 weeks)
Number of SAEs after 4 weeks of treatment with MRx0005 vs 4-weeks of placebo in participants with idiopathic PD

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
Individual participant dataSharing planned: No

Related trials for Idiopathic Parkinson Disease

Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
Recruiting
MediPD: An Online Mediterranean Diet Program for People Living With Parkinson's Disease
Parkinson Disease, Idiopathic
Recruiting
Video-oculography and Parkinson's Disease
Parkinson Disease, Idiopathic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MRx0029 and MRx0005 in people with Idiopathic Parkinson Disease, run by 4D pharma plc.

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 10 inclusion and 35 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: withdrawn, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Incidence of treatment-emergent adverse events (TEAEs) (time frame: Baseline to Follow-up Visit (up to 24 weeks)). The study lists 4 primary outcomes in all. 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 NCT05832775.

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 27 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.