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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.

Sponsors and Collaborators: Louisiana State University - Shreveport
Biogen Idec
Information provided by: Louisiana State University - Shreveport
ClinicalTrials.gov Identifier: NCT00246324
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis
Drug: Doxycycline
Phase IV

MedlinePlus related topics:   Multiple Sclerosis  

ChemIDplus related topics:   Interferon alfa-2b   Interferons   Doxycycline   Doxycycline calcium   Doxycycline hyclate   Interferon beta   Interferon-beta  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   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

Further study details as provided by Louisiana State University - Shreveport:

Primary Outcome Measures:
  • to determine whether the combination of doxycycline with Avonex will reduce the mean number of new GD+ lesions

Secondary Outcome Measures:
  • 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

Study Start Date:   December 2003
Estimated Study Completion Date:   March 2006

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246324

Locations
United States, Louisiana
LSU Health Sciences Center Shreveport    
      Shreveport, Louisiana, United States, 71103

Sponsors and Collaborators
Louisiana State University - Shreveport
Biogen Idec

Investigators
Principal Investigator:     Alireza Minagar, MD     LSU Health Sciences Center -Shreveport    
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 

Publications indexed to this study:

Study ID Numbers:   H04-090
First Received:   October 27, 2005
Last Updated:   February 6, 2008
ClinicalTrials.gov Identifier:   NCT00246324
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon-beta
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Interferon Alfa-2b
Multiple Sclerosis, Relapsing-Remitting
Doxycycline
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Antimalarials
Anti-Infective Agents
Anti-Bacterial Agents
Antiparasitic Agents
Antiprotozoal Agents
Pathologic Processes
Immune System Diseases
Therapeutic Uses
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008




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