DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Interferon beta 1a, oral doxycycline (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Louisiana State University Health Sciences Center Shreveport

Official(s) and/or principal investigator(s):
Alireza Minagar, MD, Principal Investigator, Affiliation: LSU Health Sciences Center -Shreveport

Summary

To evaluate the efficacy, safety, and tolerability of combination therapy with intramuscular interferon beta-1a and oral doxycycline, a potent inhibitor of matrix metalloproteinases, in patients with relapsing remitting multiple sclerosis (RRMS) having breakthrough disease activity.

Clinical Details

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 (RRMS)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Gadolinium-enhancing (Gd+)Lesion Number Change.

Secondary outcome:

Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes

Determine Safety and Tolerability of Combination Therapy With Avonex Plus Doxycycline

Determine Pre- and On-treatment Cytokine ELISA, MMP ELISA and Bioassay

Detailed description: Eligible individuals were evaluated monthly for 3 months while taking intramuscular interferon beta-1a, 30 micrograms weekly, then monthly for 4 months while receiving intramuscular interferon beta-1a, 30 micrograms and oral doxycycline, 100 mg daily.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- age 18-55

- Relapsing-Remitting Multiple Sclerosis (RRMS)

- Avonex therapy for 6 months prior continuous

- annualized relapse rate >2 during Avonex therapy

- most recent relapse within 60 days of baseline

- entry Expanded Disability Status Scale (EDSS) 1. 5-4. 5

- one or more gadolinium (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 chest x-ray (CXR)

Locations and Contacts

LSU Health Sciences Center Shreveport, Shreveport, Louisiana 71103, United States
Additional Information

Starting date: December 2003
Last updated: April 13, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017