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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.

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ClinicalTrials.gov Identifier: NCT00037115
Recruitment Status : Withdrawn (Lack of funding)
First Posted : May 17, 2002
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
Consultants in Neurology
Information provided by (Responsible Party):
Vernon D. Rowe III, MD, MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute

Tracking Information
First Submitted Date  ICMJE May 15, 2002
First Posted Date  ICMJE May 17, 2002
Last Update Posted Date April 12, 2018
Actual Study Start Date  ICMJE May 2002
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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.
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Demyelinating Disorders
  • Multiple Sclerosis
  • Optic Neuritis
  • Myelitis
  • Neuritis
Intervention  ICMJE
  • Drug: interferon beta 1a
  • Drug: methotrexate
  • Drug: methylprednisolone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 10, 2018)
0
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
20
Actual Study Completion Date  ICMJE December 2002
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00037115
Other Study ID Numbers  ICMJE MANI-MTX02-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vernon D. Rowe III, MD, MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
Study Sponsor  ICMJE MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
Collaborators  ICMJE Consultants in Neurology
Investigators  ICMJE Not Provided
PRS Account MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
Verification Date April 2018

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