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

October 27, 2005
April 13, 2012
December 2003
August 2009   (final data collection date for primary outcome measure)
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.
to determine whether the combination of doxycycline with Avonex will reduce the mean number of new GD+ lesions
Complete list of historical versions of study NCT00246324 on ClinicalTrials.gov Archive Site
  • 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 ]
  • to determine pre- and on-treatment relapse rate,proportion relapse free, %free of new MRI activity, and % experencing greater than 25% reduction in new MRI activity
  • determine safety and tolerability of combination therapy with Avonex plus doxycycline
  • determine pre- and on-treatment cytokine ELISA, MMP ELISA and bioassay
Not Provided
Not Provided
 
Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis
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)

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis
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
Not Provided
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 2007 Dec 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
October 2009
August 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00246324
H04-090
No
Alireza Minagar, Louisiana State University Health Sciences Center Shreveport
Louisiana State University Health Sciences Center Shreveport
Biogen Idec
Principal Investigator: Alireza Minagar, MD LSU Health Sciences Center -Shreveport
Louisiana State University Health Sciences Center Shreveport
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP