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Trial · NCT06065670

Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy

NCT06065670, Phase 1, Phase 2, Not yet recruiting, University of California, San Francisco

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy. Trials, record NCT06065670. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06065670

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy
NCT number
NCT06065670
Status
Not yet recruiting
Phases
Phase 1, Phase 2
Enrollment
44 participants, estimated
Lead sponsor
University of California, San Francisco
Conditions
Demyelinating Diseases, Demyelination; Corpus Callosum, Multiple Sclerosis Brain Lesion, Multiple Sclerosis Acute and Progressive, Clinically Isolated Syndrome, CNS Demyelinating
Interventions
Clemastine Fumarate, Placebo
First posted
2023-10-04
Last updated
2026-03-11

Source ClinicalTrials.gov

Registered outcomes48

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCorpus Callosum Myelin Water FractionThis will be assessed at the baseline visit.The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum.
PrimaryChange from Baseline in Corpus Callosum Myelin Water Fraction at 3 MonthsThis will be assessed at the baseline and 3 month visits.The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum. Change = (3-month % - Baseline %)
PrimaryChange from Baseline in Corpus Callosum Myelin Water Fraction at 6 MonthsThis will be assessed at the baseline and 6 month visits.The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum. Change = (6-month % - Baseline %)
PrimaryCorpus Callosum T1 Relaxation TimeThis will be assessed at the baseline visit.The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI.
PrimaryChange from Baseline in Corpus Callosum T1 Relaxation Time at 3 MonthsThis will be assessed at the baseline and 3-month visits.
The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI. (3-month time - Baseline time)
PrimaryChange from Baseline in Corpus Callosum T1 Relaxation Time at 6 MonthsThis will be assessed at the baseline and 6-month visits.
The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI. (6-month time - Baseline time)
PrimaryCorpus Callosum UTE FractionThis will be assessed at the baseline visit.The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum.
PrimaryChange from Baseline in Corpus Callosum UTE Fraction at 3 MonthsThis will be assessed at the baseline and 3-month visits.
The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum. Change = (3-month % - Baseline %)
PrimaryChange from Baseline in Corpus Callosum UTE Fraction at 6 MonthsThis will be assessed at the baseline and 6-month visits.
The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum. Change = (6-month % - Baseline %)
SecondaryOptic Radiation Myelin Water FractionThis will be assessed at the baseline visit.The efficacy of Clemastine relative to placebo at increasing the MWF (measured in %) of the optic radiation.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
17308868BACKGROUNDPubMed
19819338BACKGROUNDPubMed
24997607BACKGROUNDPubMed
27155128BACKGROUNDPubMed
29029896BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06065670

GET https://conductscience.org/api/trials/v1/NCT06065670/registered?page=2