Clinical trial NCT00246324: Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2005-10-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Gadolinium-enhancing (Gd+)Lesion Number Change.
timeFrame: 8 months
Secondary outcomes:
measure: Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes
timeFrame: 8 months
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: LSU Health Sciences Center Shreveport
state: Louisiana
Study officials:
affiliation: LSU Health Sciences Center -Shreveport
name: Alireza Minagar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1001/archneurol.2007.41. Epub 2007 Dec 10.