The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in adult subjects with Relapsing Forms of Multiple Sclerosis (RMS).
An interventional, open label, randomized design will be used to test safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in 50 patients ≥ 18 and ≤ 55 years of age with documented RMS. There will be a screening period of up to 28 days, 168 days treatment period, and 28 days follow-up.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
25 mg OD during the first 28 Days of the trial
25 mg BID during the first 28 Days of the trial
After 28 Days of treatment with 25 mg OD, patients will escalate to 50 mg OD up to the end of the trial
North Central Neurology Associates
Cullman, Alabama, United States
Fullerton Neurology and Headache Center
Fullerton, California, United States
Accel Research Sites - Brain and Spine Institute of Port Orange
Port Orange, Florida, United States
St. Vincent's Hospital
Melbourne, Victoria, Australia
Incidence and severity of Treatment Emergent Adverse Events
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments
Time frame: 168 days (24 weeks)
Brain lesion activity measured by MRI
Time frame: 168 days (24 weeks)
Disease progression measured by MS Functional Composite (MSFC)
The MSFC consists of three assessments of walking speed, processing speed and finger dexterity. The scores are combined to provide a Z-score (number of standard deviations away from mean of a normal population) with lower scores representing greater abnormality
Time frame: 168 days (24 weeks)
Disease progression measured by Expanded Disability Status Scale (EDSS)
The EDSS is an ordinal scale used for assessing neurological impairment of MS based on a neurological examination. It consists of scores in each of seven functional systems (FS) and an ambulation score that are then combined to determine the EDSS \[ranging from 0 (normal) to 10 (death due to MS)\]. The FSs are the Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel \& Bladder, and Cerebral functions. The FSs and EDSS steps will be assessed in a standardized manner
Time frame: 168 days (24 weeks)
Disease progression measured by Symbol Digit Modalities Test (SDMT)
The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution
Time frame: 168 days (24 weeks)
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After 28 Days of treatment with 25 mg BID, patients will escalate to 50 mg BID up to the end of the trial
Disability status measured by MS Functional Composite (MSFC)
The MSFC consists of three assessments of walking speed, processing speed and finger dexterity. The scores are combined to provide a Z-score (number of standard deviations away from mean of a normal population) with lower scores representing greater abnormality
Time frame: 168 days (24 weeks)
Disability status measured by Expanded Disability Status Scale (EDSS)
The EDSS is an ordinal scale used for assessing neurological impairment of MS based on a neurological examination. It consists of scores in each of seven functional systems (FS) and an ambulation score that are then combined to determine the EDSS \[ranging from 0 (normal) to 10 (death due to MS)\]. The FSs are the Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel \& Bladder, and Cerebral functions. The FSs and EDSS steps will be assessed in a standardized manner
Time frame: 168 days (24 weeks)
Disability status measured by Symbol Digit Modalities Test (SDMT)
The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution
Time frame: 168 days (24 weeks)
Time to first relapse
Time frame: 168 days (24 weeks)
Preliminary Annualized Relapse Rate (ARR)
Time frame: 168 days (24 weeks)
Percent of patients who experience a relapse
Time frame: 168 days (24 weeks)
Proportion of patients who remain qualified as relapse-free
Time frame: 168 days (24 weeks)
Change in blood levels of neurofilament light chain (NfL)
Time frame: Baseline, 28 Days, 56 Days, 84 Days, 112 Days, 140 Days, 168 Days