Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis
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)
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 multiple-sclerosis
Started Dec 2003
Longer than P75 for phase_4 multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 27, 2005
CompletedFirst Posted
Study publicly available on registry
October 31, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
November 17, 2011
CompletedNovember 8, 2022
October 1, 2022
5.7 years
October 27, 2005
May 5, 2011
October 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
8 months
Secondary Outcomes (1)
Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes
8 months
Study Arms (1)
Single Arm
EXPERIMENTALInterferon beta 1a, oral doxycycline
Interventions
Patients took intramuscular interferon beta 1a, 30 micrograms, for 3 months then added oral doxycycline, 100 daily with the interferon for 4 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LSU Health Sciences Center Shreveport
Shreveport, Louisiana, 71103, United States
Related Publications (1)
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.
PMID: 18071030RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alireza Minagar, MD
- Organization
- LSU Health Sciences Center in Shreveport Department of Neurology
Study Officials
- PRINCIPAL INVESTIGATOR
Alireza Minagar, MD
LSU Health Sciences Center -Shreveport
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2005
First Posted
October 31, 2005
Study Start
December 1, 2003
Primary Completion
August 1, 2009
Study Completion
October 1, 2009
Last Updated
November 8, 2022
Results First Posted
November 17, 2011
Record last verified: 2022-10