Atacicept in Subjects With Optic Neuritis

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 2

Conditions: Optic Neuritis

Treatments: Drug: Placebo matched to atacicept; Drug: Atacicept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00624468

28156

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Atacicept

Experimental group

Treatment:

Drug: Atacicept

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matched to atacicept