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Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients

NCT ID: NCT00262314

Last Updated: 2013-11-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

509 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-10-31

Study Completion Date

2008-09-30

Brief Summary

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The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.

Detailed Description

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This phase IV, multicenter, prospective, open-label tolerability and safety monitoring study will enroll a select cohort of 500 multiple sclerosis patients receiving commercially available Novantrone®. The patients will be assessed every 3 months during treatment followed by annual assessment for a total of five (5) years.

The select cohort of MS patients enrolled will have secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose neurological status is significantly abnormal between relapses).

The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:
* Platelet count \>100,000 cells/µL
* Granulocyte count \> 2000 cells/µL
* Age 18-65 years
* Negative pregnancy test for female patients who are biologically capable of becoming pregnant, even if they are taking birth control
* For patients of reproductive age, agreement to practice effective contraception throughout the study and for 6 months following the last administration of Novantrone®
* Signed Inform Consent.

Exclusion Criteria

* To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
* Presence of cardiac risk factors:
* History of congestive heart failure
* LVEF \< 50% determined by echocardiography or MUGA
* Previous treatment with Novantrone®, other anthracenediones, or anthracyclines
* Prior mediastinal radiotherapy or total lymphoidal irradiation
* AST, ALT, bilirubin \> 2x upper limits of normal
* Severe untreated infection (including current urinary tract infection)
* Nursing or pregnant women)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMD Serono

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Randy Bennett

Role: STUDY_DIRECTOR

EMD Serono

Locations

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Registrat Inc

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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19-297

Identifier Type: -

Identifier Source: secondary_id

24293

Identifier Type: -

Identifier Source: org_study_id

NCT00016614

Identifier Type: -

Identifier Source: nct_alias