CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 16 enrolled
Drug / intervention
Interferon beta 1a, oral doxycyclinedrug
Likely dose
Interferon beta-1a 30 micrograms intramuscularly for 3 months, then oral doxycycline 100 mg daily added for 4 monthsAI-extracted
Key inclusion· 8
  • Age 18-55 years
  • Diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS)
  • At least 6 months continuous treatment with Avonex prior to study entry
  • Annualized relapse rate >2 during Avonex therapy
Key exclusion· 8
  • Interferon neutralizing antibody titers ≥20
  • Prior use of monoclonal antibodies within 6 months of study entry
  • Prior systemic steroids within 6 months of study entry
  • Prior cytotoxic or immunosuppressive medications (e.g. mitoxantrone, cyclophosphamide) within 6 months of study entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00246324
NCT00246324Phase 4Completed

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)

Louisiana State University Health Sciences Center Shreveport·interventional·Posted Oct 31, 2005·Updated Nov 8, 2022

In Brief

A Phase 4 clinical trial evaluating Interferon beta 1a, oral doxycycline for Multiple Sclerosis. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsBiogen

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 31, 2005
Enrollment StartDec 1, 2003
Primary CompletionAug 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 20.7 years ago

Interventions

Interferon beta 1a, oral doxycyclinedrug

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