Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)|
- Gadolinium-enhancing (Gd+)Lesion Number Change. [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Determine Pre- and On-treatment Cytokine ELISA, MMP ELISA and Bioassay [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2003|
|Study Completion Date:||October 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Drug: Interferon beta 1a, oral doxycycline
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246324
|United States, Louisiana|
|LSU Health Sciences Center Shreveport|
|Shreveport, Louisiana, United States, 71103|
|Principal Investigator:||Alireza Minagar, MD||LSU Health Sciences Center -Shreveport|