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Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis
This study is ongoing, but not recruiting participants.
Study NCT00246324   Information provided by Louisiana State University - Shreveport
First Received: October 27, 2005   Last Updated: February 6, 2008   History of Changes

October 27, 2005
February 6, 2008
December 2003
 
to determine whether the combination of doxycycline with Avonex will reduce the mean number of new GD+ lesions
Same as current
Complete list of historical versions of study NCT00246324 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis
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

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

 
Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Multiple Sclerosis
Drug: Doxycycline
 
Minagar A, Alexander JS, Schwendimann RN, Kelley RE, Gonzalez-Toledo E, Jimenez JJ, Mauro L, Jy W, Smith SJ. Combination therapy with interferon beta-1a and doxycycline in multiple sclerosis: an open-label trial. Arch Neurol. 2008 Feb;65(2):199-204. Epub 2007 Dec 10.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
March 2006
 

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00246324
 
H04-090
Louisiana State University - Shreveport
Biogen Idec
Principal Investigator: Alireza Minagar, MD LSU Health Sciences Center -Shreveport
Louisiana State University - Shreveport
December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP