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| Descriptive Information Fields | |||||
| 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 | ||||
| Brief Summary | The purpose of this study is to determine if combining an antibiotic to the normal regimen of interferon in multiple sclerosis patients will decrease the gad-ehancing lesions on MRI imaging |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | to determine whether the combination of doxycycline with Avonex will reduce the mean number of new GD+ lesions | ||||
| Secondary Outcome Measure † | to determine pre- and on-treatment relapse rate,proportion relapse free, %free of new MRI activity, and % experencing greater than 25% reduction in new MRI activity determine safety and tolerability of combination therapy with Avonex plus doxycycline determine pre- and on-treatment cytokine ELISA, MMP ELISA and bioassay |
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| Condition † | Multiple Sclerosis | ||||
| Intervention † | Drug: Doxycycline | ||||
| MEDLINE PMIDs | |||||
| Links | Related Info ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | |||||
| Start Date † | December 2003 | ||||
| Completion Date | March 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00246324 | ||||
| Organization ID | H04-090 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Louisiana State University - Shreveport | ||||
| Collaborators †† | Biogen Idec | ||||
| Investigators † |
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| Information Provided By | Louisiana State University - Shreveport | ||||
| Verification Date | December 2004 | ||||
| First Received Date † | October 27, 2005 | ||||
| Last Updated Date | February 6, 2008 | ||||