Recruitment

Recruitment Status
Unknown status

Summary

Conditions
Multiple Sclerosis
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Min Age
19
Max Age
65
Gender
Both

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 manifestation: Acute onset or worsening of any of the manifestations of CNS relapses (excluding spinal cord) ...

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 manifestation: Acute onset or worsening of any of the manifestations of CNS relapses (excluding spinal cord) including: Brain stem syndrome Optic neuritis Cerebellar syndromes If they choose to participate, subjects will be asked to: Meet at the Clinic 4 times: Initial visit 5 days after baseline visit 14 days after baseline visit 30 days after baseline visit Meet with neurologist for neurological exam that will include a: Review of neurological status Review of new and ongoing symptoms Review of symptom resolution Review of any side effects or adverse events Resolution of any patient questions and concerns Provide a 40cc whole blood sample At each of the 4 visits Consent to Acthar Gel treatment for their relapse for 14 days (or as required for their relapse) Ss will agree to be trained in self-administration of Acthar First dose administered at Baseline visit Self-administered days 2-14 of participation Complete 4 psychometric instruments At baseline and 30 day visit Cognitive assessment using the Brief International Cognitive Assessment for MS (Benedict 2012) Administered by Tanner Center Staff specially trained in this assessment Quality of Life assessments: self-administered MSQoL (Cella et al, 1006) Psychological Adjustment to Illness Survey (Rodrigue et al 2000) Coping Skills Inventory (Liveneh, 2003) Participate in a brief semi-structured interview, at Day 5 visit

Locations

Birmingham, Alabama, 35209
Birmingham, Alabama, 35209

Tracking Information

NCT #
NCT01906684
Collaborators
  • Mallinckrodt
  • Auburn University MRI Research Center
  • iReportoire Inc
Investigators
  • Principal Investigator: Emily S Riser, MD Tanner Center for MS
  • Emily S Riser, MD Tanner Center for MS