Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis

This study has been completed.

Study NCT00246324 Information provided by Louisiana State University Health Sciences Center Shreveport

First Received on October 27, 2005. Last Updated on October 7, 2011 History of Changes

Results First Received: May 5, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Multiple Sclerosis
Intervention:	Drug: Interferon beta 1a, oral doxycycline

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Inteferon, Then Interferon With Doxycycline	Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.

Participant Flow: Overall Study

	Inteferon, Then Interferon With Doxycycline
STARTED	16
COMPLETED	15
NOT COMPLETED	1
Withdrawal by Subject	1

Baseline Characteristics

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Reporting Groups

	Description
Inteferon, Then Interferon With Doxycycline	Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.

Baseline Measures

	Inteferon, Then Interferon With Doxycycline
Number of Participants [units: participants]	16
Age [units: participants]
<=18 years	0
Between 18 and 65 years	16
>=65 years	0
Age [units: years] Mean ± Standard Deviation	44.5 ± 10.6
Gender [units: participants]
Female	12
Male	4
Region of Enrollment [units: participants]
United States	16

Outcome Measures

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1. Primary:

Gadolinium-enhancing (Gd+)Lesion Number Change. [ Time Frame: 8 months ]

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2. Secondary:

Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes [ Time Frame: 8 months ]

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3. Secondary:

Determine Safety and Tolerability of Combination Therapy With Avonex Plus Doxycycline [ Time Frame: 8 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

4. Secondary:

Determine Pre- and On-treatment Cytokine ELISA, MMP ELISA and Bioassay [ Time Frame: 8 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Alireza Minagar, MD
Organization: LSU Health Sciences Center in Shreveport Department of Neurology
phone: 318-813-1481
e-mail: aminag@lsuhsc.edu

Publications of Results:

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. Epub 2007 Dec 10.

Responsible Party:	Alireza Minagar, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier:	NCT00246324 History of Changes
Other Study ID Numbers:	H04-090
Study First Received:	October 27, 2005
Results First Received:	May 5, 2011
Last Updated:	October 7, 2011
Health Authority:	United States: Institutional Review Board