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

Relapsing Remitting Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203073
• Other study ID #: NC-100
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: April 13, 2011
• Start date: June 2003
• Est. completion date: April 2005

Study information

• Verified date: April 2011
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• glatiramer acetate 20 mg
glatiramer acetate 20 mg
• glatiramer acetate 20 mg, with mitoxantrone
glatiramer acetate 20 mg, with mitoxantrone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		15 months	Yes

External Links

•   For further information concerning Multiple Sclerosis