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

Condition(s) targeted: Multiple Sclerosis

Intervention: Doxycycline (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Louisiana State University - Shreveport

Official(s) and/or principal investigator(s):
Alireza Minagar, MD, Principal Investigator, Affiliation: LSU Health Sciences Center -Shreveport

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

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

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

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

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

LSU Health Sciences Center Shreveport, Shreveport, Louisiana 71103, United States

Starting date: December 2003
Ending date: March 2006
Last updated: February 6, 2008