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

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
Alireza Minagar, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier:
NCT00246324
First received: October 27, 2005
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: Interferon beta 1a, oral doxycycline
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center Shreveport:

Primary Outcome Measures:
  • Gadolinium-enhancing (Gd+)Lesion Number Change. [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    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:
  • Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    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.

  • Determine Safety and Tolerability of Combination Therapy With Avonex Plus Doxycycline [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • Determine Pre- and On-treatment Cytokine ELISA, MMP ELISA and Bioassay [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: December 2003
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246324

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

Publications:
Responsible Party: Alireza Minagar, Assistant Professor Department of Neurology, 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: April 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Doxycycline
Interferon beta 1a
Interferon-beta
Interferons
Adjuvants, Immunologic
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014