Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT00246324 |
Recruitment Status :
Completed
First Posted : October 30, 2005
Results First Posted : November 17, 2011
Last Update Posted : July 22, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Drug: Interferon beta 1a, oral doxycycline | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | December 2003 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | October 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Single Arm
Interferon beta 1a, oral doxycycline
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Drug: Interferon beta 1a, oral doxycycline
Patients took intramuscular interferon beta 1a, 30 micrograms, for 3 months then added oral doxycycline, 100 daily with the interferon for 4 months.
Other Name: Avonex |
- Gadolinium-enhancing (Gd+)Lesion Number Change. [ Time Frame: 8 months ]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.
- Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes [ Time Frame: 8 months ]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.
- Determine Safety and Tolerability of Combination Therapy With Avonex Plus Doxycycline [ Time Frame: 8 months ]
- Determine Pre- and On-treatment Cytokine ELISA, MMP ELISA and Bioassay [ Time Frame: 8 months ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246324
United States, Louisiana | |
LSU Health Sciences Center Shreveport | |
Shreveport, Louisiana, United States, 71103 |
Principal Investigator: | Alireza Minagar, MD | LSU Health Sciences Center -Shreveport |
Responsible Party: | Louisiana State University Health Sciences Center Shreveport |
ClinicalTrials.gov Identifier: | NCT00246324 |
Other Study ID Numbers: |
H04-090 |
First Posted: | October 30, 2005 Key Record Dates |
Results First Posted: | November 17, 2011 |
Last Update Posted: | July 22, 2020 |
Last Verified: | July 2020 |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Interferons Interferon-beta Interferon beta-1a |
Doxycycline Antineoplastic Agents Antiviral Agents Anti-Infective Agents Anti-Bacterial Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |