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 31, 2005
Results First Posted : November 17, 2011
Last Update Posted : April 4, 2018
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Single Arm
Interferon beta 1a, oral doxycycline
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 ]
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|