Ignite Creation Date:
2024-05-06 @ 1:44 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01888354
Status:
COMPLETED
Last Update Posted:
2014-09-16
First Post:
2013-05-16
Brief Title:
Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous SQVersus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous SQ Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study is designed as a prospective cohort study to determine whether standard subcutaneous SQ Highly-Purified HP Acthar Gel 14 days is superior to SQ HP Acthar Gel 5 days in the treatment of relapses or attacks in multiple sclerosis MS
Detailed Description:
Evaluations and treatment will be administered as an outpatient in the Neurology Clinic Each subject will be seen for MS relapse or exacerbation in the Neurology Clinic during a routine or semi-emergent visit Patients will be offered an FDA approved treatment ACTHar Gel for MS attacks under a standard 14 day SQ protocol standard 14 day SQ protocol 80 IU x 14 days or a 5 day SQ protocol - 5 day subcutaneous protocol 80 IU x 5 days Both protocols are within package insert guidelines The subjects will be evaluated for Extended Disability Status Scales EDSS a standardized measure of clinical status in MS and the initial visit and 28 days later and 90 days later We will compare the change in EDSS outcomes between day 0 and day 28 day 90 to determine if the 14 days is superior to 5 day protocol may be clinically equivalent Patients will also be evaluated for walking upper extremity function 9 hole peg test cognition and vision
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None