NCT00624468

Atacicept in Subjects With Optic Neuritis

A Two-arm, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Evaluate Safety and Tolerability and to Explore the Neuroprotective Effect of Atacicept as Assessed by Optical Coherence Tomography (OCT) in Subjects With Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) Over a 36-week Treatment Course

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Optic Neuritis

Interventions

Type	Name	Description
DRUG	Atacicept	Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
DRUG	Placebo matched to atacicept	Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-09-01
• Completion: 2011-01-01
• First posted: 2008-02-27
• Last updated: 2016-02-17
• Results posted: 2016-02-17

Locations

28 sites across 11 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Lebanon, Spain, Switzerland, United Kingdom