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.
Written informed consent must be obtained prior to any assessment being performed.
Patients diagnosed with relapsing remitting multiple sclerosis and a disease duration of < 15 years
Male or female patients aged 18-55 years (inclusive)
Post-menopausal for at least 1 year OR
Radiologic identification of marked brain atrophy relative to patients age based on recent MRI and interpretation of expert neuroradiologist or PI
New lesion in most recent MRI (within 3 months)
Hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients.
Treatment with corticosteroids within 30 days prior to screening.
Crossover
Clemastine Fumarate
Drug12 or 8 mg Clemastine tablet. Clemastine fumarate was approved by the Food and Drug Administration (FDA) for the treatment of allergic rhinitis (seasonal allergies) in 1977 and was approved for over-the-counter marketing in 1992. Clemastine is not FDA approved as a remyelinating therapy
Placebo
DrugMatched sugar tablet
Corpus Callosum Myelin Water Fraction
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 from Baseline in Corpus Callosum Myelin Water Fraction at 3 Months
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 %)
Change from Baseline in Corpus Callosum Myelin Water Fraction at 6 Months
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 %)
Corpus Callosum T1 Relaxation Time
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.
Optic Radiation Myelin Water Fraction
The efficacy of Clemastine relative to placebo at increasing the MWF (measured in %) of the optic radiation.
Change from Baseline in Optic Radiation Myelin Water Fraction at 3 Months
The efficacy of Clemastine relative to placebo at increasing the MWF (measured in %) of the optic radiation. Change = (3-month % - Baseline %)
Change from Baseline in Optic Radiation Myelin Water Fraction at 6 Months
The efficacy of Clemastine relative to placebo at increasing the MWF (measured in %) of the optic radiation. Change = (6-month % - Baseline %)
Corticospinal Tract Myelin Water Fraction
The efficacy of clemastine relative to placebo at increasing the MWF (measured in %) of the corticospinal tract.
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