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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])
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00624468
First received: February 15, 2008
Last updated: April 22, 2011
Last verified: April 2011
History of Changes
  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 2

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 June 17, 2013