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NCT06065670 · ClinicalTrials.gov registry record · Phase 1
Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy
A Phase 1 study, sponsored by University of California, San Francisco.
- Not yet
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT06065670: Clinical Trial Phase 1 study, sponsored by University of California, San Francisco.
NCT06065670 is a Phase 1 study that has not yet begun recruiting, run by University of California, San Francisco. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06065670, a Phase 1 study, has not yet begun recruiting, sponsored by University of California, San Francisco.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with acute inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments. No reparative therapies exist for the treatment of acute demyelinating lesions. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at the University of California, San Francisco (UCSF). Following in vivo validation, an FDA IND exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577. This study seeks to follow up on that study and examine clemastine fumarate's protective and reparative effects in the context of acute demyelinating brain lesions as imaged by multi-parametric MRI assessments. The investigators will be assessing the effects of clemastine fumarate as a remyelinating therapy and assessing its effect on MRI metrics of lesions found in patients with a confirmed diagnosis of acute inflammatory injury-causing demyelination. In addition to using conventional multi-parametric MRI assessments, this study will also evaluate a new MRI technique called Ultrashort Echo Time (UTE) MRI to assess the effects of clemastine fumarate as a remyelinating therapy of acute lesions found in patients with a confirmed diagnosis of acute inflammatory injury-causing demyelination and compare it to the other assessments.
Primary Outcome
The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum.
Interventions
- DRUG Placebo
- DRUG Clemastine Fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2026-09-15 |
| Est. Completion | 2028-10-30 |
| Phase | Phase 1 |
What is known before NCT06065670 opens enrollment
NCT06065670 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06065670 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06065670 about?
NCT06065670 is a clinical study titled "Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy". The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with acute inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments. No reparative therapies exist for the treatment of acute demyelinating l...
What is the current status of trial NCT06065670?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2026-09-15. Estimated completion is 2028-10-30.
What interventions are being tested in trial NCT06065670?
The interventions under investigation include: Placebo (DRUG), Clemastine Fumarate (DRUG).
Who is sponsoring clinical trial NCT06065670?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06065670's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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