Multiple Sclerosis Clinical Trial
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.
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT02845635 -
MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
|