Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with a relapsing disease course.
- 2.EDSS 0.0 - 6.5 inclusive
- 18 to 55 years of age
- 1 or more T1 Gadolinium-enhancing lesions but no more than 15 lesions
- Able and willing to sign and date an informed consent form
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00203073
Start Date
June 1 2003
End Date
April 1 2005
Last Update
April 14 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.