Comprehensive Analysis of Relapse in Multiple Sclerosis

NCT ID: NCT01906684

Last Updated: 2013-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-01-31

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

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 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

Conditions

Multiple Sclerosis

Keywords

Acthar Gel; MS relapse; 7T MRI imaging; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acthar Gel

Acthar Gel is supplied as 5 mL multi-dose vial (63004-8710-1) containing 80 USP Units per mL. H.P. Acthar Gel (repository corticotropin injection). Acthar Gel will be administered as a subcutaneous daily dose of 80 units for up to 2 weeks.

Group Type: EXPERIMENTAL

Acthar Gel

Intervention Type: DRUG

Patients who present with MS relapse within 72 hours of onset will be recruited for study. Upon consent they will be administered Achtar Gel for 5-14 days as clinically appropriate.

Interventions

Acthar Gel

Patients who present with MS relapse within 72 hours of onset will be recruited for study. Upon consent they will be administered Achtar Gel for 5-14 days as clinically appropriate.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: collaborator

Auburn University MRI Research Center

UNKNOWN

Sponsor Role: collaborator

iReportoire Inc

UNKNOWN

Sponsor Role: collaborator

Tanner Foundation for Multiple Sclerosis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily S Riser, MD

Role: PRINCIPAL_INVESTIGATOR

Tanner Center for MS

Locations

Tanner Center for MS

Birmingham, Alabama, United States

Countries

United States

Central Contacts

Ritalinda D Lee, PhD

Role: CONTACT

Phone: 256-714-0683

Email: rlee@tannerms.org

Other Identifiers

TFMS:QP1-2013

Identifier Type: -

Identifier Source: org_study_id