Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy, safety, and tolerability of combination therapy with intramuscular interferon beta-1a and oral doxycycline, a potent inhibitor of matrix metalloproteinases, in patients with relapsing remitting multiple sclerosis (RRMS) having breakthrough disease activity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Louisiana State University Health Sciences Center Shreveport
• Collaborator: Biogen
• Treatments: Doxycycline; Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• age 18-55

• Relapsing-Remitting Multiple Sclerosis (RRMS)

• Avonex therapy for 6 months prior continuous

• annualized relapse rate >2 during Avonex therapy

• most recent relapse within 60 days of baseline

• entry Expanded Disability Status Scale (EDSS) 1.5-4.5

• one or more gadolinium (Gd+) MRI lesions on a baseline MRI

• no history of immune modulator or immunosuppressant therapy used in combination with Avonex (other then GSC administer for clinical relapses)

• not participating in any other study of ms therapeutics

• Serum neutralizing antibodies (NABs) titer to Avonex <20

Exclusion Criteria:

• Medical or Psychiatric conditions that will affect patients ability to provide informed consent

• inability to undergo MRI

• clinically serious medical conditions or significantly abnormal labs

• no use of these medications or procedures within six months prior to study:

*monoclonal antibodies,total lymphoid radiation,systemic steroids,cytotoxic or immunosuppressive medications such as mitoxantrone or cyclophosphamide or any other investigational drugs

• Interferon neutralizing antibody titers >20

• no breast feeding or pregnant

• no patients with any systemic illness,psychiatric condition or other disorder that would concern safety of patient to complete procedures of protocol

• abnormal blood test

• clinically significant abnormality on chest x-ray (CXR)