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

This study is ongoing, but not recruiting participants.

First Received: October 27, 2005 Last Updated: February 6, 2008 History of Changes

Sponsor:	Louisiana State University - Shreveport
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium Interferons

U.S. FDA Resources

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Louisiana State University - Shreveport

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

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

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Antineoplastic Agents
Nervous System Diseases
Interferons
Sclerosis
Antiviral Agents
Multiple Sclerosis, Relapsing-Remitting

Pharmacologic Actions
Antimalarials
Anti-Bacterial Agents
Antiparasitic Agents
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Doxycycline

ClinicalTrials.gov processed this record on November 05, 2009