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A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.

This study has been completed.
Information provided by:
Teva Pharmaceutical Industries Identifier:
First received: September 13, 2005
Last updated: April 13, 2011
Last verified: April 2011
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.

Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: glatiramer acetate 20 mg
Drug: glatiramer acetate 20 mg, with mitoxantrone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis.

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Determine if short-term immunosuppression with mitoxantrone (Novantrone®) followed by chronic treatment with Glatiramer Acetate (GA) in comparison to treatment with GA for the same period of time but without immunosuppression is well-tolerated and safe [ Time Frame: 15 months ]

Enrollment: 40
Study Start Date: June 2003
Study Completion Date: April 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Copaxone 20 mg
Copaxone 20 mg
Drug: glatiramer acetate 20 mg
glatiramer acetate 20 mg
Other Name: Copaxone
Active Comparator: Copaxone 20mg with Novantrone induction
Copaxone 20mg with Novantrone induction
Drug: glatiramer acetate 20 mg, with mitoxantrone
glatiramer acetate 20 mg, with mitoxantrone
Other Name: Copaxone, Novantrone


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with a relapsing disease course.
  2. 2.EDSS 0.0 - 6.5 inclusive
  3. 18 to 55 years of age
  4. 1 or more T1 Gadolinium-enhancing lesions but no more than 15 lesions
  5. Able and willing to sign and date an informed consent form

Exclusion Criteria:

  1. Patients ever treated with Glatiramer Acetate or Mitoxantrone.
  2. Patients treated with interferons or IV immunoglobulins (IV Ig) in the previous 4 weeks prior to screening visits.
  3. Patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits.
  4. Patients ever treated with cyclophosphamide or Total Lymphoid Irradiation (TLI), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy.
  5. Patients treated with intravenous or oral steroids within 28 days prior to initial MRI.
  6. Female patients must be non-pregnant, non-lactating, have a negative screening pregnancy test, and must use contraceptive methods deemed reliable by the investigator.
  7. Male patients and their partners must use contraceptive methods deemed reliable by the investigator
  8. LVEF < 50%
  9. Patients using catheters or Foley catheters
  10. 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
  11. Patients with immune deficiency or other medical condition that would preclude treatment with Mitoxantrone or Glatiramer Acetate
  12. 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

  13. Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
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Please refer to this study by its identifier: NCT00203073

Sponsors and Collaborators
Teva Pharmaceutical Industries
Study Director: Siyu Liu, MD Teva Neuroscience, Inc.
  More Information

Additional Information:
Responsible Party: Siyu Liu, VP, NA Innovative R&D, Teva Neuroscience Identifier: NCT00203073     History of Changes
Other Study ID Numbers: NC-100
Study First Received: September 13, 2005
Last Updated: April 13, 2011

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Glatiramer Acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Sensory System Agents
Peripheral Nervous System Agents
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 25, 2017