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

Sponsor:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00203073

Purpose

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	Intervention	Phase
Relapsing Remitting Multiple Sclerosis	Drug: glatiramer acetate 20 mg Drug: glatiramer acetate 20 mg, with mitoxantrone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Mitoxantrone Mitoxantrone hydrochloride Copolymer 1

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	40
Study Start Date:	June 2003
Study Completion Date:	April 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203073

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

Siyu Liu, MD

Teva Neuroscience, Inc.

More Information

Additional Information:

For further information concerning Multiple Sclerosis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Siyu Liu, VP, NA Innovative R&D, Teva Neuroscience
ClinicalTrials.gov Identifier:	NCT00203073 History of Changes
Other Study ID Numbers:	NC-100
Study First Received:	September 13, 2005
Last Updated:	April 13, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Mitoxantrone
Copolymer 1

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012