Status and phase
Conditions
Treatments
About
It is thought that treating multiple sclerosis with Novantrone for a short period of time prior to treatment with Copaxone may enhance the onset effect of Copaxone.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Patients ever treated with Glatiramer Acetate or Mitoxantrone.
Patients treated with interferons or IV immunoglobulins (IV Ig) in the previous 4 weeks prior to screening visits.
Patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits.
Patients ever treated with cyclophosphamide or Total Lymphoid Irradiation (TLI), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy.
Patients treated with intravenous or oral steroids within 28 days prior to initial MRI.
Female patients must be non-pregnant, non-lactating, have a negative screening pregnancy test, and must use contraceptive methods deemed reliable by the investigator.
Male patients and their partners must use contraceptive methods deemed reliable by the investigator
LVEF < 50%
Patients using catheters or Foley catheters
Patients who have any other known significant systemic medical disease which may confound the evaluation of the study results such as: ALS, cervical spondylitic myelopathy, syphilis, arteritis, cerebellar syndrome (i.e., due to heredodegeneration), B12/folate deficiency, lyme disease, HTLV 1-myelopathy
Patients with immune deficiency or other medical condition that would preclude treatment with Mitoxantrone or Glatiramer Acetate
Abnormal screening blood tests exceeding any of the limits defined below:
Alanine transaminase (ALT) - twice the upper limit of normal Aspartate transaminase (AST) - twice the upper limit of normal Total white blood cell count < 2.3 x 103/uL Baseline neutrophil counts of < 1.5 x103/uL Platelet count < 80 x 103/uL Creatinine >1.5 mg/dL Prothrombin time greater than 150% upper limit of normal
Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal