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Report for D020529: Multiple Sclerosis, Relapsing-Remitting NIH

(Synonyms: Multiple Sclerosis, R, Multiple Sclerosis, Relap, Multiple Sclerosis, Relapsi, Multiple Sclerosis, Relapsing-Rem, Multiple Sclerosis, Relapsing-Remittin, Multiple Sclerosis, Relapsing-Remitting)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug2425 Repository Corticotropin Injection Wiki 1.00
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D012598 Scoliosi NIH 0.30
D009103 Multiple Sclerosis NIH 0.29

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple Sclerosis

This is a multicenter, multiple dose study to estimate the response rate, and examine the safety of H.P. Acthar® Gel (Acthar) in subjects with RRMS who have not responded to high dose steroids. Approximately 66 subjects will be randomized.

NCT03126760 Relapsing, Remitting Multiple Sclerosis Drug: Repository Corticotropin Injection Drug: Placebo
MeSH:Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis

Primary Outcomes

Description: The EDSS is a 10 step assessment of neurological impairment/disability in MS ranging from 0 (normal neurological examination) to 10 (death due to MS) that is completed by a blinded rater. The blinded rater will not be involved in any aspects of participant care and management other than performing the EDSS/FSS evaluations in participant in the study.

Measure: Response rate on Expanded Disability Status Scale (EDSS) at Day 42

Time: Day 42

Description: Data for AE and SAE will be presented.

Measure: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time: Up to Day 42

Description: Data will be summarized for each visit.

Measure: Change from Baseline in diastolic/systolic blood pressures

Time: Baseline and Up to Day 42

Measure: Change from Baseline in respiratory rate

Time: Baseline and Up to Day 42

Measure: Change from Baseline in heart rate

Time: Baseline and Up to Day 42

Measure: Change from Baseline in body temperature

Time: Baseline and Up to Day 42

Measure: Change from Baseline in Clinically Significant Laboratory Test Abnormalities - Hematology

Time: Baseline and Up to Day 42

Measure: Change from Baseline in Clinically Significant Laboratory Test Abnormalities - blood chemistry

Time: Baseline and Up to Day 42

Measure: Change from Baseline in Clinically Significant Laboratory Test Abnormalities -urinalysis

Time: Baseline and Up to Day 42

Secondary Outcomes

Description: The MSIS-29 measures the physical (20 items) and psychological (9 items) impact of MS from the participant's perspective. This validated questionnaire will result in a total score between 29 and 145 and can provide separate scores for physical and psychological impact. The MSIS-29 will be completed by the participant at all required times points during the study except on Study Day 14 when the MSIS-29 will be administered via telephone by a call center trained in the administration of the MSIS-29 or captured via a web portal.

Measure: The response rates on Multiple Sclerosis Impact Scale Version 1 (MSIS-29) and 90% confidence intervals (CIs)

Time: Days 7, 14, 21 and 42

Description: The EDSS is a 10 step assessment of neurological impairment/disability in MS ranging from 0 (normal neurological examination) to 10 (death due to MS) that is completed by a blinded rater. The blinded rater will not be involved in any aspects of participant care and management other than performing the EDSS/FSS evaluations in participant in the study.

Measure: The response rates on EDSS and 90% CIs on Day 7 and Day 21

Time: Days 7 and 21

Description: The CGI-I was developed for use in clinical research to provide a brief overview of the change in a participant's global function compared to baseline and regardless of study drug treatment. It requires a rating from 1 (very much improved) to 7 (very much worse).

Measure: Clinical Global Impression of Improvement Scale (CGI-I) mean scores and 90% CIs

Time: Days 7, 21 and 42


HPO Nodes