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

Multiple Sclerosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246324
• Other study ID #: H04-090
• Status: Completed
• Phase: Phase 4
• Start date: December 2003
• Est. completion date: October 2009

Study information

• Verified date: October 2022
• Source: Louisiana State University Health Sciences Center Shreveport
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

• 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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	LSU Health Sciences Center Shreveport	Shreveport	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center Shreveport	Biogen

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gadolinium-enhancing (Gd+)Lesion Number Change.	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.	8 months
Secondary	Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes	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.	8 months