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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00246324
Recruitment Status : Completed
First Posted : October 30, 2005
Results First Posted : November 17, 2011
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Alireza Minagar, Louisiana State University Health Sciences Center Shreveport

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Interferon beta 1a, oral doxycycline Phase 4

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : December 2003
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm
Interferon beta 1a, oral doxycycline
 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.
Other Name: Avonex


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


Secondary Outcome Measures :
  1. Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes [ Time Frame: 8 months ]
    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.

  2. Determine Safety and Tolerability of Combination Therapy With Avonex Plus Doxycycline [ Time Frame: 8 months ]
  3. Determine Pre- and On-treatment Cytokine ELISA, MMP ELISA and Bioassay [ Time Frame: 8 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246324


Locations
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United States, Louisiana
LSU Health Sciences Center Shreveport
Shreveport, Louisiana, United States, 71103
Sponsors and Collaborators
Louisiana State University Health Sciences Center Shreveport
Biogen
Investigators
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Principal Investigator: Alireza Minagar, MD LSU Health Sciences Center -Shreveport
More Information
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Publications of Results:

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Responsible Party: Alireza Minagar, Assistant Professor Department of Neurology, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT00246324    
Other Study ID Numbers: H04-090
First Posted: October 30, 2005    Key Record Dates
Results First Posted: November 17, 2011
Last Update Posted: April 4, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
 Doxycycline
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic