Status:
UNKNOWN
Comprehensive Analysis of Relapse in Multiple Sclerosis
Lead Sponsor:
Tanner Foundation for Multiple Sclerosis
Collaborating Sponsors:
Mallinckrodt
Auburn University MRI Research Center
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
This study will determine changes in: 1) the immune activity, characterized as the "immunorepertoire;" 2) 7 Tesla MRI brain images; 3) clinical outcomes; and 4) patient reported quality of life outcom...
Detailed Description
20 patients with documented Multiple Sclerosis, who have been diagnosed within 12 months of enrollment in the study and who are currently experiencing an MS relapse, defined as the following manifesta...
Eligibility Criteria
Inclusion
- Patients will be eligible to participate in the study if:
- They were diagnosed with Relapsing-Remitting Multiple Sclerosis within 1 year of their participation in the study Are established patients of the Tanner Center for MS Seek care for relapse within 72 hours of onset Are between the ages of 19 and 65 inclusively.
- Relapse will be confirmed and defined as the acute worsening of function that lasts for at least 24 hours with any of the manifestations of Central Nervous System relapses (excluding spinal cord) including:
- Brain stem syndrome Optic neuritis Cerebellar syndromes Hemi-motor/sensory events Males and Females are both eligible Patients of any race or ethnicity are eligible Are not pregnant (as confirmed by pregnancy test at the time of enrollment) or nursing Have no known contraindicating conditions (see exclusions)
Exclusion
- Potential participants will be excluded if they do not meet the above criteria, and also if:
- They are currently being treated for MS with the any of the following disease-modifying drugs: Tysabri, Gilenya, Aubagio, Tecfidera They have a history of experiencing significant adverse reactions to corticosteroids They are deemed by Dr Riser to be better served with an intervention other than Acthar Gel to treat their current MS relapse Are pregnant or nursing
- Are known to have any of the contraindicating conditions:
- Scleroderm Osteoporosis Systemic fungal infections Ocular herpes simplex Recent surgery History of or presence of peptic ulcer Congestive heart failure Uncontrolled hypertension Adreno-cortical insufficiency, hyper-function or sensitivity Sensitivity to proteins of porcine origin
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01906684
Start Date
August 1 2013
End Date
January 1 2015
Last Update
August 1 2013
Active Locations (1)
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1
Tanner Center for MS
Birmingham, Alabama, United States, 35209