ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01906684
Previous Study | Return to List | Next Study

Comprehensive Analysis of Relapse in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01906684
Recruitment Status : Unknown
Verified July 2013 by Tanner Foundation for Multiple Sclerosis.
Recruitment status was:  Not yet recruiting
First Posted : July 24, 2013
Last Update Posted : August 1, 2013
Sponsor:
Collaborators:
Mallinckrodt
Auburn University MRI Research Center
iReportoire Inc
Information provided by (Responsible Party):
Tanner Foundation for Multiple Sclerosis

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Acthar Gel Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comprehensive Analysis of Relapse in Multiple Sclerosis
Study Start Date : August 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Changes in immunorepertoire, MRI imaging, clinical outcomes and patient reported quality of life [ Time Frame: within 1 month post initiation of treatment with Acthar Gel ]
    This study will observe changes in the activity of b cells and t cells as evidenced in the patient's immunorepertoire, as well as changes in 7T MRI images, physician-documented clinical outcomes in patients receiving Acthar Gel for treatment of MS relapse at four time points: baseline, 5, 14 and 30 days post initiation of treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906684


Contacts
Contact: Ritalinda D Lee, PhD 256-714-0683 rlee@tannerms.org

Locations
United States, Alabama
Tanner Center for MS Recruiting
Birmingham, Alabama, United States, 35209
Principal Investigator: Emily S Riser, MD         
Sponsors and Collaborators
Tanner Foundation for Multiple Sclerosis
Mallinckrodt
Auburn University MRI Research Center
iReportoire Inc
Investigators
Principal Investigator: Emily S Riser, MD Tanner Center for MS

Responsible Party: Tanner Foundation for Multiple Sclerosis
ClinicalTrials.gov Identifier: NCT01906684     History of Changes
Other Study ID Numbers: TFMS:QP1-2013
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: August 1, 2013
Last Verified: July 2013

Keywords provided by Tanner Foundation for Multiple Sclerosis:
Acthar Gel
MS relapse
7T MRI imaging
Quality of Life

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Recurrence
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs