Comprehensive Analysis of Relapse in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title: Comprehensive Analysis of Relapse in Multiple Sclerosis

Status Not yet recruiting

Clinical Trial 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 outcomes in subjects with relapsing-remitting multiple sclerosis who are treated with Acthar Gel.

Clinical Trial 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) 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 ;

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

• NCT number: NCT01906684
• Study type: Interventional
• Source: Tanner Foundation for Multiple Sclerosis
• Contact: Ritalinda D Lee, PhD
• Phone: 256-714-0683
• Email: rlee@tannerms.org
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2013
• Completion date: January 2015