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OpenTrials
Completed

NCT Number: NCT00203073

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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.

Treatment and study plan

glatiramer acetate 20 mg

Drug

glatiramer acetate 20 mg

Other names: Copaxone

glatiramer acetate 20 mg, with mitoxantrone

Drug

glatiramer acetate 20 mg, with mitoxantrone

Other names: Copaxone, Novantrone

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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