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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
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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
June 1, 2008
Primary Completion Date
September 1, 2009
Completion Date
January 1, 2011
Last Updated
February 17, 2016
34
ACTUAL participants
Atacicept
DRUG
Placebo matched to atacicept
DRUG
Lead Sponsor
EMD Serono
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03401879