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

Louisiana State University Health Sciences Center Shreveport

Status and phase

Completed

Phase 4

Conditions

Multiple Sclerosis

Treatments

Drug: Interferon beta 1a, oral doxycycline

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00246324

H04-090

Details and patient eligibility

About

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.

Full 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, 30 micrograms and oral doxycycline, 100 mg daily.

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)