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

Tracking Information

First Received Date ^ICMJE

October 27, 2005

Last Updated Date

February 6, 2008

Start Date ^ICMJE

December 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

to determine whether the combination of doxycycline with Avonex will reduce the mean number of new GD+ lesions

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00246324 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

Drug: Doxycycline

Study Arms / Comparison Groups

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

March 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00246324

Responsible Party

Study ID Numbers ^ICMJE

H04-090

Study Sponsor ^ICMJE

Louisiana State University - Shreveport

Collaborators ^ICMJE

Biogen Idec

Investigators ^ICMJE

Principal Investigator:

Alireza Minagar, MD

LSU Health Sciences Center -Shreveport

Information Provided By

Louisiana State University - Shreveport

Verification Date

December 2004

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