Status:
COMPLETED
Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis
Lead Sponsor:
Louisiana State University Health Sciences Center Shreveport
Collaborating Sponsors:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00246324
Start Date
December 1 2003
End Date
October 1 2009
Last Update
November 8 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
LSU Health Sciences Center Shreveport
Shreveport, Louisiana, United States, 71103