Trial | NCT01906684  Report issue

Official Title

Comprehensive Analysis of Relapse in Multiple Sclerosis

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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.
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 Started
Aug 31
2013
Primary Completion
Jan 31
2014
Anticipated
Study Completion
Jan 31
2015
Anticipated
Last Update
Aug 01
2013
Estimate

Drug 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.

Acthar Gel Experimental

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.

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
No Results Posted