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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00203073
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 14, 2011
Information provided by:
Teva Pharmaceutical Industries

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00203073

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

Additional Information:
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Responsible Party: Siyu Liu, VP, NA Innovative R&D, Teva Neuroscience Identifier: NCT00203073     History of Changes
Other Study ID Numbers: NC-100
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Glatiramer Acetate
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Antirheumatic Agents