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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Interferon beta 1a, oral doxycycline

Group Type EXPERIMENTAL

Interferon beta 1a, oral doxycycline

Intervention Type DRUG

Patients took intramuscular interferon beta 1a, 30 micrograms, for 3 months then added oral doxycycline, 100 daily with the interferon for 4 months.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Avonex

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes