Multiple Sclerosis Clinical Trial

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Atacicept in Subjects With Optic Neuritis

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Summary

This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.

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Eligibility Criteria

Inclusion Criteria:

Diagnosis of unilateral symptomatic optic neuritis as first clinical manifestation within 28 days between onset of symptoms and study Day 1
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Pre treatment with immunosuppressants and immunomodulating drugs
Relevant cardiac, hepatic and renal diseases
Clinical significant abnormalities in blood cell counts and immunoglobulin levels
Clinical significant acute or chronic infections
Other protocol defined exclusion criteria could apply

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

34

Study ID:

NCT00624468

Recruitment Status:

Terminated

Sponsor:

EMD Serono

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There is 1 Location for this study

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Research Site
Birmingham Alabama, , United States
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Aurora Colorado, , United States
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Fairfield Connecticut, , United States
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Jacksonville Florida, , United States
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East Lansing Michigan, , United States
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Philadelphia Pennsylvania, , United States
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Houston Texas, , United States
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Burlington Vermont, , United States
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Parkville Victoria, , Australia
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Bruxelles , , Belgium
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Vancouver British Columbia, , Canada
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Ottawa Ontario, , Canada
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Montreal Quebec, , Canada
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Hradec Kralove , , Czech Republic
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Olomouc , , Czech Republic
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Paris , , France
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Freiburg , , Germany
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Munich , , Germany
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Tübingen , , Germany
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Würzburg , , Germany
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Beyrouth , , Lebanon
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Dbayeh , , Lebanon
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Barcelona , , Spain
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Sevilla , , Spain
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Valencia , , Spain
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Lausanne , , Switzerland
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London , , United Kingdom
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Sheffield , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

34

Study ID:

NCT00624468

Recruitment Status:

Terminated

Sponsor:


EMD Serono

How clear is this clinincal trial information?

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