Phase 4
Completed N=16
Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis
Source: ClinicalTrials.gov NCT00246324 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcomePrimary: Gadolinium-enhancing (Gd+)Lesion Number Change. — 4.0 Gd+ lesions
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 relapsing remitting multiple sclerosis (RRMS) having breakthrough disease activity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gadolinium-enhancing (Gd+)Lesion Number Change. |
4.0 | — |
| SECONDARY Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes |
15 | — |
Eligibility Criteria
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
- 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)
Data sourced from ClinicalTrials.gov (NCT00246324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.