Official Title: “An Open Label Trial of Safety and Efficacy of Combination Therapy With Interferon-B-1a and Oral Doxycycline in Patients With Relapsing-Remitting Multiple Sclerosis”

The purpose of this study is to determine if combining an antibiotic to the normal regimen of interferon in multiple sclerosis patients will decrease the gad-ehancing lesions on MRI imaging

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Doxycycline

Primary Measures

• to determine whether the combination of doxycycline with Avonex will reduce the mean number of new GD+ lesions

Secondary Measures

• to determine pre- and on-treatment relapse rate,proportion relapse free, %free of new MRI activity, and % experencing greater than 25% reduction in new MRI activity
• determine safety and tolerability of combination therapy with Avonex plus doxycycline
• determine pre- and on-treatment cytokine ELISA, MMP ELISA and bioassay

Inclusion Criteria:

• age 18-55
• RRMS
• Avonex therapy for 6 months prior continous
• annualized relapse rate >2 during Avonex therapy
• most recent relapse within 60 days of baseline
• entry EDSS 1.5-4.5
• one or more 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 CXR

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Louisiana State University - Shreveport

Overall Clinical Trial Officials and Contacts

Alireza Minagar, MD Principal Investigator LSU Health Sciences Center -Shreveport  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00246324

Study ID Number: H04-090

ClinicalTrials.gov Identifier: NCT00246324

Health Authority: United States: Institutional Review Board