Phase 2 Multiple Sclerosis Trial, Not Yet Recruiting
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
- People who have given written consent to participate in the study.
- People who speak English.
- Men and women aged 18 to 60 years old (inclusive).
- People who have a confirmed diagnosis of relapsing or progressive multiple sclerosis (any form), as defined by the 2024 McDonald Diagnostic Criteria, confirmed at the time of the screening visit.
- People with a disability score (EDSS) between 0 and 6.5 (inclusive) — this is a standard MS disability scale (confirm with trial site).
- People with adequate vision and movement ability to take part in the study assessments.
- Women who are surgically sterilised (for example, via hysterectomy, removal of both ovaries, or tubal ligation) for at least 6 months, or who have not had any menstrual bleeding for at least 1 year (postmenopausal).
- Women who are not postmenopausal and agree to use two methods of contraception at the same time (one of which must be a barrier method, such as a condom plus an intrauterine device or spermicidal gel) starting 30 days before the first dose until 30 days after the last dose, and who have a negative pregnancy test at screening and each follow-up visit.
- Men who have not had a vasectomy and agree to use contraception (barrier method or abstinence) from 30 days before the first dose until 30 days after the last dose.
- People who have had at least one MS relapse, one new or active brain lesion on a specific type of MRI scan, or measurable worsening of disability in the past 12 months.
- People who are in reasonably good general health and whose MS has been neurologically stable for the past month, with no MS relapse during that time.
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.
- People currently being treated with any disease-modifying therapy for MS, or with systemic immune-suppressing treatment for other autoimmune or inflammatory conditions (such as rheumatoid arthritis, lupus, or inflammatory bowel disease).
- People with ongoing drug or alcohol misuse, or any other factor that might affect their ability to follow the study procedures.
- People with a history of cancer of any type in the past 5 years, with the exception of fully removed localised skin basal cell carcinoma or cervical cancer that had not spread.
- People with a history of liver disease or abnormal liver function, including Gilbert syndrome, acute or chronic liver disease, cirrhosis, any level of liver impairment, untreated hepatitis C, active hepatitis B, alcohol intake above recommended limits, or abnormal liver blood test results at the start of the study.
- People with a history of severe kidney disease or abnormal kidney function blood test results above a certain level.
- People who are pregnant or planning to become pregnant.
- People with a history of severe depression or suicidal thoughts or behaviour.
- People with certain abnormal blood test results at screening, including low red blood cells, low platelets, low white blood cells, low immune cell counts, or low antibody levels (confirm specific values with trial site).
- People with an active, clinically significant infection (bacterial, viral, parasitic, or fungal) at the time of screening, in the judgement of the investigator.
- People with a significant history of other serious nervous system conditions, such as stroke, traumatic brain injury, spinal cord disease, or a serious brain infection called progressive multifocal leukoencephalopathy.
- People who have had their spleen removed.
- People with a history of active or latent tuberculosis, confirmed by a positive QuantiFERON test at screening.
- People with a known immune deficiency condition, a drug-related immune deficiency, a hereditary immune deficiency, or a positive HIV test at screening.
- People with serious heart, kidney, liver, hormone, metabolic, blood, lung, or digestive disorders that the investigator believes could affect safety or interfere with the study results.
- People with a history or current diagnosis of certain heart rhythm problems, a family history of long QT syndrome, or heart rhythm conditions requiring treatment with specific anti-arrhythmic medications.
- People with a specific heart electrical measurement (QTcF interval) above a certain threshold on a resting ECG before screening (confirm specific values with trial site).
- People who require blood-thinning medication or dual anti-platelet therapy (low-dose aspirin up to 100 mg/day or clopidogrel up to 75 mg/day are permitted).
- People with a significant risk of bleeding or a history of clinically significant bleeding disorders.
- People using medications that reduce stomach acid, such as proton pump inhibitors or H2 blockers.
- People using certain medications or supplements that affect how the body processes drugs, including some antibiotics, antifungals, anti-seizure medications, St John's Wort, modafinil, grapefruit, or certain other drugs — or any herbal or dietary supplements within 8 weeks before the first dose or during the study (confirm specific medications with trial site).
- People who have received live vaccines within 6 weeks before screening, or who would need live vaccines at any point during the study.
- People who are unable to have an MRI scan with contrast dye, for any reason such as claustrophobia, a pacemaker, cochlear implant, incompatible metal implants, allergy to the contrast dye, or severe kidney disease.
- People who answer "yes" to certain questions about suicidal thoughts or behaviour on a standard assessment scale (C-SSRS) at screening.
- People whom the investigator considers to be at risk for any other reason, or whose participation might make the study results difficult to interpret.
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.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Principal Investigator: Moein Amin, MD, MS, The Cleveland Clinic
Phone: 216-636-1232
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Quantitative MRI volumetric measurements; Slowly expanding lesions (SELs); Paramagnetic rim lesions (PRLs) -- count; Paramagnetic rim lesions (PRLs) -- size; Paramagnetic rim lesions (PRLs) -- quantitative susceptibility measures; Myelin Water Fraction; Functional MRI (Default mode network); Microstructural tissue integrity; Leptomeningeal enhancement; Neuromelanin
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.