Atacicept in Optic Neuritis, Phase II

This study has been terminated.

( EMD Serono voluntarily decided to terminate this trial after observing increased MS disease activity in trial 28063 ATAMS [Please refer to ATAMS] )

First Received on February 15, 2008. Last Updated on April 22, 2011 History of Changes

Sponsor:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00624468

Purpose

This study is intended to evaluate the evaluate safety and tolerability of atacicept compared to placebo 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). The study is randomized. Study medication is administered via subcutaneous (under the skin) injections

Condition	Intervention	Phase
Optic Neuritis	Drug: Atacicept Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Two-arm, Randomised, 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

Further study details as provided by EMD Serono:

Primary Outcome Measures:

Change of RNFL thickness assessed by OCT. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measures of RNFL integrity and visual function [ Time Frame: weeks 12, 24, 36 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	March 2008
Study Completion Date:	January 2011
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Atacicept 150 mg	Drug: Atacicept Atacicept s.c. QW
Placebo Comparator: 2 Placebo	Drug: Placebo Matching Placebo

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of unilateral symptomatic optic neuritis as first clinical manifestation

Exclusion Criteria:

Other differential diagnoses

Pre treatment with immunosuppressants and immunomodulating drugs
Relevant cardiac, hepatic and renal diseases
Clinical significant abnormalities in blood cell counts and Ig Levels
Clinical significant acute or chronic infections

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624468

Show 28 Study Locations

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Dan Mikol, MD, PhD

EMD Serono

More Information

No publications provided

Responsible Party:	Laurence Darmency, Merck Serono S.A. - Geneva an Affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:	NCT00624468 History of Changes
Other Study ID Numbers:	28156
Study First Received:	February 15, 2008
Last Updated:	April 22, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases

Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012