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

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: glatiramer acetate 20 mg; Drug: glatiramer acetate 20 mg, with mitoxantrone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00203073

NC-100

Details and patient eligibility

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: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Copaxone 20 mg

Active Comparator group

Description:

Copaxone 20 mg

Treatment:

Drug: glatiramer acetate 20 mg

Copaxone 20mg with Novantrone induction

Active Comparator group

Description:

Copaxone 20mg with Novantrone induction

Treatment:

Drug: glatiramer acetate 20 mg, with mitoxantrone