Phase 2 Multiple Sclerosis Trial, Recruiting NCT05359653 Sponsor: University of California, San Francisco Condition: Multiple Sclerosis
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Phase 2 Multiple Sclerosis Trial, Recruiting

NCT05359653
Recruiting Phase 2

Who may 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 might be able to join this trial:

  • People who are able to give written consent before any assessments are done
  • People who have been diagnosed with relapsing remitting multiple sclerosis and have had the condition for less than 15 years
  • People aged 18 to 55 years old (inclusive)
  • Women who meet at least one of the following conditions around pregnancy prevention: have been through menopause for at least one year; have had a surgical procedure that prevents pregnancy (such as hysterectomy, removal of both ovaries, or tubal ligation); have a male partner who has had a vasectomy; are using a highly effective form of birth control for the full duration of the trial; are not currently in a heterosexual relationship but agree to use highly effective birth control if that changes; or are not sexually active in a way that could lead to pregnancy as part of their regular lifestyle (note: calendar or ovulation-tracking methods alone are not accepted)

Who may not be able to join:

  • People whose most recent MRI shows significant brain shrinkage for their age, as assessed by a specialist radiologist or the trial doctor
  • People who have a new lesion (area of damage) showing on an MRI taken within the last 3 months
  • People who have had an allergic reaction to clemastine, similar antihistamine medicines, or any ingredients in the trial medication
  • People who have been treated with corticosteroids (a type of anti-inflammatory medicine) in the 30 days before screening
  • People who score 4.5 or higher on a standard disability scale used to measure MS progression (confirm with trial site)
  • People with a history of a significant heart conduction problem (an issue with the electrical signals that control the heartbeat)
  • People with a history of cancer
  • People who have had thoughts of suicide or suicidal behaviour in the 6 months before the start of the trial
  • People who are pregnant, breastfeeding, or planning to become pregnant
  • People already taking part in another research study at the same time, unless the trial site has given prior approval
  • People currently using any other treatment intended to repair the myelin (protective coating on nerves), as decided by the trial doctor
  • People who have previously received total lymphoid irradiation, or T cell or T cell receptor vaccination
  • People who have previously been treated with alemtuzumab, mitoxantrone, or cyclophosphamide (specific medicines used in some MS or cancer treatments)
  • People whose recent blood test results (taken within 72 hours) show kidney or liver function outside of acceptable ranges (confirm specific values with trial site)
  • People with a history of drug or alcohol misuse within the past year
  • People with untreated vitamin B12 deficiency or untreated underactive thyroid, as confirmed by blood tests
  • People with other significant ongoing health conditions that, in the trial doctor's judgement, could affect the safety of participation or the interpretation of results
  • People who are unable to have an MRI scan, including those with severe claustrophobia
  • People who have dental braces or any permanent or non-removable metal in the jaw or face

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.
Last synced 19 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Ari J Green, MD, MCR, University of California, San Francisco

Phone: 415-745-1304

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

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 August 2023
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Corpus Callosum Myelin Water Fraction; Change from Baseline in Corpus Callosum Myelin Water Fraction at 3 Months; Change from Baseline in Corpus Callosum Myelin Water Fraction at 6 Months; Corpus Callosum T1 Relaxation Time; Change from Baseline in Corpus Callosum T1 Relaxation Time at 3 Months; Change from Baseline in Corpus Callosum T1 Relaxation Time at 6 Months; Corpus Callosum UTE Fraction; Change from Baseline in Corpus Callosum UTE Fraction at 3 Months; Change from Baseline in Corpus Callosum UTE Fraction at 6 Months

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 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.

View original record on ClinicalTrials.gov