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drug2425 | Repository Corticotropin Injection Wiki | 1.00 |
drug2122 | Placebo Wiki | 0.05 |
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D012598 | Scoliosi NIH | 0.30 |
D009103 | Multiple Sclerosis NIH | 0.29 |
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There is one clinical trial.
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.
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 42Description: 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 42Description: Data will be summarized for each visit.
Measure: Change from Baseline in diastolic/systolic blood pressures Time: Baseline and Up to Day 42Description: 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 42Description: 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 21Description: 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