Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Multiple Sclerosis (Relapsing Remitting) and Multiple Sclerosis, Primary Progressive, sponsored by University of California, San Francisco.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
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.
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 |
What NCT05359653 shows while recruiting
NCT05359653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 560-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis (Relapsing Remitting)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05359653's enrollment target sits among peer trials
74 17th of 29 higher than 13 of 29 other Multiple Sclerosis (Relapsing Remitting) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis (Relapsing Remitting) 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
-
Safety of RG2077 in Patients With Multiple Sclerosis
COMPLETED · Phase 1
-
Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis
COMPLETED · Phase 1
-
Motor Learning of Fall Resistant Skills Through Slip and Trip Exposure in Multiple Sclerosis
RECRUITING · NA
-
Intermittent Hypoxia in Persons With Multiple Sclerosis
RECRUITING · NA
-
Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation
RECRUITING · NA
-
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03422731 · 74 participants · Early Phase 1
Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
- NCT03804853 · 74 participants · NA
Rehabilitation Following Reverse Total Shoulder Arthroplasty
- NCT04065776 · 74 participants · NA
Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma
- NCT04771156 · 74 participants · Phase 4
Ketorolac in Palatoplasty
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI