Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event. - Full Text View

Sponsor:	MidAmerica Neuroscience Institute
Collaborator:	Consultants in Neurology
Information provided by:	MidAmerica Neuroscience Institute
ClinicalTrials.gov Identifier:	NCT00037115

Purpose

The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and a one-time high dose intravenous methotrexate with Leucovorin rescue, along with the standard solumedrol treatment before beginning AVONEX® treatment.

Condition	Intervention	Phase
Demyelinating Disorders Multiple Sclerosis Optic Neuritis Myelitis Neuritis	Drug: interferon beta 1a Drug: methotrexate Drug: methylprednisolone	Phase IV

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 Pilot Study of Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event: Comparison With CHAMPS Results.

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Leucovorin Methotrexate Citrovorum factor Interferon beta Interferon-beta Medrol veriderm Methylprednisolone Interferon beta 1a Prednisolone sodium phosphate Leucovorin Calcium Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate Folinic acid calcium salt pentahydrate 6-Methylprednisolone Interferons

U.S. FDA Resources

Further study details as provided by MidAmerica Neuroscience Institute:

Estimated Enrollment:	20
Study Start Date:	May 2002

Detailed Description:

The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and a one-time high dose intravenous methotrexate with Leucovorin rescue, along with the standard solumedrol treatment before beginning AVONEX® treatment.

At study entrance, baseline lab work (complete blood count, platelet count, routine electrolytes, blood urea nitrogen, creatinine, liver function tests, 24 hour urine collection for creatinine clearance, urine pregnancy test, urinalysis and urine culture and sensitivity if needed), and an electrocardiogram (measurement of heart activity) will be done. A complete medical history, neurological and opthamological examination will be performed, including measurements of vital signs (heart rate and blood pressure), as well as magnetic resonance imaging (MRI), EDSS, and Visual Evoked Response test (VER's) to document status of disease. A Multiple Sclerosis Functional Composite Score (MSFC) consists of the Timed 25 Foot Walk, Nine Hole Peg Test (9HPT), and Paced Auditory Serial Addition Test 3 (PASAT3) will be performed at screen as well. At months 6, 12, 18, 24, 30 and 36 the tests and evaluations will include MRI, MSFC, VER's and blood tests of immune cells. Other safety evaluations (previously mentioned blood and urine tests) will be conducted according to the date of treatment. These tests include a laboratory test (methotrexate level) two days following treatment, as well as routine lab tests 2 weeks following the methotrexate treatment. This treatment would be under the supervision of Dr. Rowe.

The patients will continue their AVONEX® intramuscular injections of 30 micrograms (administered by patient or caregiver) on a weekly basis. The methylprednisolone treatment and methotrexate infusion will be performed in our outpatient infusion center. The patient will be required to complete a patient diary during the course of the trial, participate in and keep all scheduled appointments, and to inform the research staff and physician of any change in concomitant medications or adverse events that they may experience.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

To be eligible for entry into this study, candidates must meet the following eligibility criteria at the time of enrollment, which are the same as in the CHAMPS study [1]:

Between the ages of 18 and 50 years, inclusive.
As in the CHAMPS study [1] patients must have had a first isolated, well-defined neurologic event consistent with demyelination and involving the optic nerve (unilateral optic neuritis), spinal cord (incomplete transverse myelitis), or brain stem or cerebellum (brain stem or cerebella syndrome). They must also have two or more clinically silent lesions of the brain that were at least 3 mm in diameter on MRI scans and were characteristic of MS (at least one lesion must be periventricular or ovoid).
The onset of the visual or neurological symptoms must have occurred no more than twelve days before the MTX treatment, so that the methylprednisolone treatment is begun no more than fourteen days after the onset of symptoms, as in CHAMPS.
Patients must give written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037115

Locations

United States, Missouri
MidAmerica Neuroscience Institute
Kansas City, Missouri, United States, 64108

Sponsors and Collaborators

MidAmerica Neuroscience Institute

Consultants in Neurology

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00037115 History of Changes
Other Study ID Numbers:	MANI-MTX02-001
Study First Received:	May 15, 2002
Last Updated:	November 20, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by MidAmerica Neuroscience Institute:

Demyelinating
Multiple Sclerosis
Myelitis
Neuritis
Optic Neuritis
AVONEX
methotrexate
methylprednisolone

interferon beta 1a
demyelination
central nervous system
brain
nerve
lesions
enhancement
enhancing

Additional relevant MeSH terms:

Demyelinating Diseases
Multiple Sclerosis
Myelitis
Neuritis
Optic Neuritis
Sclerosis
Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases

Spinal Cord Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Pathologic Processes
Interferon-beta
Interferons
Methotrexate
Interferon beta 1a
Methylprednisolone Hemisuccinate
Prednisolone
Leucovorin
Methylprednisolone acetate

ClinicalTrials.gov processed this record on February 12, 2012