Atacicept in Subjects With Optic Neuritis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Optic Neuritis

In brief

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.

Key facts

Study ID

NCT00624468

Run by

EMD Serono

People needed

34

Starts

2008-06-01

Expected to finish

2011-01-01

Last updated by the study team

2016-02-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Fairfield, Connecticut, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — East Lansing, Michigan, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Houston, Texas, United States
• Research Site — Burlington, Vermont, United States
• Research Site — Parkville, Victoria, Australia
• Research Site — Brussels, Belgium
• Research Site — Vancouver, British Columbia, Canada
• Research Site — Ottawa, Ontario, Canada
• Research Site — Montreal, Quebec, Canada
• Research Site — Hradec Králové, Czechia
• Research Site — Olomouc, Czechia
• Research Site — Paris, France
• Research Site — Freiburg im Breisgau, Germany
• Research Site — Munich, Germany
• Research Site — Tübingen, Germany
• Research Site — Würzburg, Germany
• Research Site — Beirut, Lebanon
• Research Site — Dbaïyé, Lebanon
• Research Site — Barcelona, Spain
• Research Site — Seville, Spain
• Research Site — Valencia, Spain

Full record on ClinicalTrials.gov

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