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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Interferon beta 1a, oral doxycycline
Sponsored by
Louisiana State University Health Sciences Center Shreveport
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • LSU Health Sciences Center Shreveport

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Interferon beta 1a, oral doxycycline

Outcomes

Primary Outcome Measures

Gadolinium-enhancing (Gd+)Lesion Number Change.
Before treatment is the number of lesions per image from months -3, -2, -1, and 0. During treatment is the number of lesions from months 1,2, and 3. The mean number of Gd+ lesions during each treatment period was calculated for each patient as the total number of Gd+ lesions observed across all images divided by the number of images. Hence, the mean number of Gd+ lesions per patient represents the number of lesions per MRI.

Secondary Outcome Measures

Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes
Only 1 patient relapsed. Correlations between decrease serum metalloproteinase 9 levels and enhancing lesion activity reduction. Transendothelial migration of monocytes was suppressed. Adverse effects were mild. No adverse synergistic effects of combination therapy.

Full Information

First Posted
October 27, 2005
Last Updated
October 11, 2022
Sponsor
Louisiana State University Health Sciences Center Shreveport
Collaborators
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00246324
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 (RRMS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Louisiana State University Health Sciences Center Shreveport
Collaborators
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Interferon beta 1a, oral doxycycline
Intervention Type
Drug
Intervention Name(s)
Interferon beta 1a, oral doxycycline
Other Intervention Name(s)
Avonex
Intervention Description
Patients took intramuscular interferon beta 1a, 30 micrograms, for 3 months then added oral doxycycline, 100 daily with the interferon for 4 months.
Primary Outcome Measure Information:
Title
Gadolinium-enhancing (Gd+)Lesion Number Change.
Description
Before treatment is the number of lesions per image from months -3, -2, -1, and 0. During treatment is the number of lesions from months 1,2, and 3. The mean number of Gd+ lesions during each treatment period was calculated for each patient as the total number of Gd+ lesions observed across all images divided by the number of images. Hence, the mean number of Gd+ lesions per patient represents the number of lesions per MRI.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes
Description
Only 1 patient relapsed. Correlations between decrease serum metalloproteinase 9 levels and enhancing lesion activity reduction. Transendothelial migration of monocytes was suppressed. Adverse effects were mild. No adverse synergistic effects of combination therapy.
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Minagar, MD
Organizational Affiliation
LSU Health Sciences Center -Shreveport
Official's Role
Principal Investigator
Facility Information:
Facility Name
LSU Health Sciences Center Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18071030
Citation
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. doi: 10.1001/archneurol.2007.41. Epub 2007 Dec 10.
Results Reference
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Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis

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