Printed from Voxsanity (voxsanity.com.au) — NCT06330077 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Multiple Sclerosis Trial, Not Yet Recruiting
NCT06330077
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
For patients with MS:
- People who have signed a consent form at the pre-inclusion visit
- People aged between 18 and 55 years old at the time of the pre-inclusion visit
- People diagnosed with relapsing-remitting multiple sclerosis (a form of MS with flare-ups and periods of recovery) according to 2017 McDonald criteria at the pre-inclusion visit
- People who, in the investigator's judgment, are able to follow the study procedures and understand its purpose and risks
- People registered with French social security (AME holders are excluded) at the time of the pre-inclusion visit
- People who have a specific abnormal result on a visual evoked potential (a test measuring how fast the brain responds to what the eyes see) — specifically, at least one eye showing a P100 latency above 118ms at the pre-inclusion visit
- People whose qualifying eye has a retinal nerve fibre layer thickness above 70 μm on a specialised eye scan (OCT), to help ensure enough nerve fibres remain for the study's treatment to potentially work, at the pre-inclusion visit
- People who are either currently taking an approved MS disease-modifying therapy (first or second line) or not taking any MS therapy at the pre-inclusion visit
- People with an EDSS score (a scale measuring MS-related disability) of 6 or below at the pre-inclusion visit
- Women who could become pregnant must be using a highly effective form of contraception (such as the pill, an intrauterine device, hormonal device, sterilisation, or another method with a failure rate below 1%)
For healthy volunteers:
- People who have signed a consent form
- People aged between 18 and 55 years old
- Women who could become pregnant must be using a highly effective form of contraception (such as the pill, an intrauterine device, hormonal device, sterilisation, or another method with a failure rate below 1%)
- People who, in the investigator's judgment, are able to follow the study procedures
- People registered with French social security (AME holders are excluded)
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
For patients with MS:
- People who have had an acute optic neuritis (sudden inflammation of the eye nerve) in the 6 months before the pre-inclusion visit
- People who have had an MS relapse (other than optic neuritis) in the 6 months before the pre-inclusion visit
- People who have received methylprednisolone (a steroid given by drip) in the 4 weeks before the pre-inclusion visit
- People with known reasons they cannot take the study drug (ifenprodil or placebo) or the other substances used in the study (gadolinium contrast dye or a PET scan tracer called florbetaben)
- People who are unable to have an MRI scan for any reason, including but not limited to weighing 140 kg or more, having a pacemaker, cochlear implants, metal fragments in the eye, certain brain clips, recent surgery within 6 weeks, a coronary stent fitted within 8 weeks, or known allergy to gadolinium contrast dye (confirm with trial site for full list)
- People who have had a PET scan as part of clinical research in the past 12 months
- People with a known or newly discovered significant problem with the heart's electrical system (cardiac conduction block)
- People with a condition where blood pressure drops significantly upon standing up (a fall of more than 20 mmHg in the top number and/or more than 10 mmHg in the bottom number)
- People with known long QT syndrome, or in whom a long QT interval (above 450ms on a corrected reading) is found at the pre-inclusion visit — this relates to a specific heart rhythm measurement
- People with any uncontrolled serious health condition, including cancer, infection, blood disorders, liver problems, immune system issues, hormonal disorders, neurological conditions, skin conditions, psychiatric conditions, allergies, kidney disease, or heart disease
- People with reduced kidney function (creatinine clearance below 60 ml/min) at the pre-inclusion visit
- People with elevated liver enzyme levels (ASAT, ALAT, or alkaline phosphatase more than 3 times the upper normal limit) at the pre-inclusion visit
- People with known galactosaemia (inability to process a type of sugar), glucose malabsorption, or lactase deficiency (inability to digest lactose)
- People with known poor vein access, or in whom this is found to be a problem at the pre-inclusion visit
- People with a low platelet count (below 100,000/mm³), which affects blood clotting
- Women who are pregnant or breastfeeding
- People under legal guardianship or protected legal status (curatorship or tutorship)
- People who are detained or under a security measure
- People currently participating in another clinical trial involving a health product, any other randomised trial, or still within an exclusion period from a previous study
- People who refuse to be told about any clinically significant unexpected findings discovered during the MRI
- People being treated for high blood pressure with certain medicines that block the alpha-adrenergic system, either acting on the body (prazosine, urapidil, moxisylyte, labetalol) or the brain (clonidine, monoxidine, methyldopa)
For healthy volunteers:
- People who are unable to have an MRI scan for any reason, including but not limited to weighing 140 kg or more, having a pacemaker, cochlear implants, metal fragments in the eye, certain brain clips, recent surgery within 6 weeks, or a coronary stent fitted within 8 weeks (confirm with trial site for full list)
- People who cannot have a PET scan, including women who are pregnant, or people who have had nuclear medicine radiation as part of clinical research in the year before the baseline visit
- People with known reasons they cannot receive the PET scan tracer (florbetaben)
- People with any known neurological condition
- Women who are pregnant or breastfeeding
- People with poor vein access
- People with severe kidney disease (creatinine clearance below 60 ml/min)
- People under legal guardianship or protected legal status (curatorship or tutorship)
- People who are detained or under a security measure
- People currently participating in another clinical trial involving a health product, any other randomised trial, or still within an exclusion period from a previous study
- People who refuse to be told about any clinically significant unexpected findings discovered during the MRI
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Phone: 0171970659
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 March 2024
Est. completion
1 March 2027
Where this trial is recruiting
🇫🇷 France
Primary endpoints
Change in P100 latency according to visual evoked potential.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.