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NCT05359653 · ClinicalTrials.gov registry record · Phase 1
Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy
A Phase 1 study of Multiple Sclerosis (Relapsing Remitting) and Multiple Sclerosis, Primary Progressive, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT05359653 is a Phase 1 study of Multiple Sclerosis (Relapsing Remitting) and Multiple Sclerosis, Primary Progressive that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 74 participants, below the 560-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05359653, a Phase 1 study of Multiple Sclerosis (Relapsing Remitting) and Multiple Sclerosis, Primary Progressive, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study Summary
The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with chronic inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments. No reparative therapies exist for the treatment of multiple sclerosis. 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 chronic 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 chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis. 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 chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis and compare it to the other assessments.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Clemastine Fumarate
Study Locations (1)
California
- Sandler Neurosciences Building, Neurological Clinical Research Unit - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05359653
The ClinicalTrials.gov registry entry for NCT05359653 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 560-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (87% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Multiple Sclerosis (Relapsing Remitting) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05359653 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05359653 about?
NCT05359653 is a clinical study titled "Assessing Changes in Multi-parametric MRI in MS Patients 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 chronic inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments. No reparative therapies exist for the treatment of multiple sclerosis....
What is the current status of trial NCT05359653?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2023-08-01. Estimated completion is 2026-06-01.
What conditions does trial NCT05359653 study?
This clinical trial studies the following conditions: Multiple Sclerosis (Relapsing Remitting), Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, MS, Multiple Sclerosis Relapse, Multiple Sclerosis, Chronic Progressive.
What interventions are being tested in trial NCT05359653?
The interventions under investigation include: Placebo (DRUG), Clemastine Fumarate (DRUG).
Who is sponsoring clinical trial NCT05359653?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05359653 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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