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

ClinicalTrials.gov processed this record on April 17, 2014