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

NCT00203073 | Completed Phase 2

• 1 other identifier: NC-100
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

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

  15 months

Study Arms (2)

Copaxone 20 mg

ACTIVE COMPARATOR

Copaxone 20 mg

Drug: glatiramer acetate 20 mg

Copaxone 20mg with Novantrone induction

ACTIVE COMPARATOR

Copaxone 20mg with Novantrone induction

Drug: glatiramer acetate 20 mg, with mitoxantrone

Interventions

glatiramer acetate 20 mg DRUG

glatiramer acetate 20 mg

Also known as: Copaxone

Copaxone 20 mg

glatiramer acetate 20 mg, with mitoxantrone DRUG

glatiramer acetate 20 mg, with mitoxantrone

Also known as: Copaxone, Novantrone

Copaxone 20mg with Novantrone induction

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Glatiramer Acetate; Mitoxantrone

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds

Study Officials

• Siyu Liu, MD

  Teva Neuroscience, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2003
• Primary Completion: January 1, 2005
• Study Completion: April 1, 2005
• Last Updated: April 14, 2011

Record last verified: 2011-04