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

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 (RRMS)”

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.

Eligible individuals were evaluated monthly for 3 months while taking intramuscular interferon beta-1a, 30 micrograms weekly, then monthly for 4 months while receiving intramuscular interferon beta-1a, 30 micrograms and oral doxycycline, 100 mg daily.

Intervention(s) in this Clinical Trial

• Drug: Interferon beta 1a, oral doxycycline
  • Patients took intramuscular interferon beta 1a, 30 micrograms, for 3 months then added oral doxycycline, 100 daily with the interferon for 4 months.

Primary Measures

• Gadolinium-enhancing (Gd+)Lesion Number Change.
  • Time Frame: 8 months
    Safety Issue?: Yes

Secondary Measures

• Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes
  • Time Frame: 8 months
    Safety Issue?: Yes
• Determine Safety and Tolerability of Combination Therapy With Avonex Plus Doxycycline
  • Time Frame: 8 months
    Safety Issue?: Yes
• Determine Pre- and On-treatment Cytokine ELISA, MMP ELISA and Bioassay
  • Time Frame: 8 months
    Safety Issue?: Yes

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)

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 Investigator: Louisiana State University Health Sciences Center Shreveport Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

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