Status:
TERMINATED
Atacicept in Subjects With Optic Neuritis
Lead Sponsor:
EMD Serono
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Optic Neuritis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00624468
Start Date
June 1 2008
End Date
January 1 2011
Last Update
February 17 2016
Active Locations (28)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Aurora, Colorado, United States
3
Research Site
Fairfield, Connecticut, United States
4
Research Site
Jacksonville, Florida, United States