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

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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.
Information provided by Louisiana State University - Shreveport

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Multiple Sclerosis

Intervention ^†

Drug: Doxycycline

MEDLINE PMIDs

Links

Related Info This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

December 2003

Completion Date

March 2006

Eligibility 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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00246324

Organization ID

H04-090

Secondary IDs ^††

Study Sponsor ^†

Louisiana State University - Shreveport

Collaborators ^††

Biogen Idec

Investigators ^†

Principal Investigator:

Alireza Minagar, MD

LSU Health Sciences Center -Shreveport

Information Provided By

Louisiana State University - Shreveport

Verification Date

December 2004

First Received Date ^†

October 27, 2005

Last Updated Date

February 6, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.