Atacicept in Optic Neuritis, Phase II - Full Text View

Sponsors and Collaborators:	EMD Serono ZymoGenetics
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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Frederic Monnot, PharmD

+41 22 414 3376

Frederic.monnot@merckserono.net

Locations

United States, Massachusetts
EMD Serono	Recruiting
Rockland, Massachusetts, United States, 02370
Contact: US Local Med Info 888-275-7376
Canada, British Columbia
Research Site	Recruiting
Vancouver, British Columbia, Canada
Canada, Ontario
Research Site	Recruiting
Ottawa, Ontario, Canada
Canada, Quebec
Research Site	Recruiting
Montreal, Quebec, Canada
Lebanon
Research Site	Recruiting
Beyrouth, Lebanon
Research Site	Recruiting
Rabieh, Lebanon
Spain
Research Site	Recruiting
Barcelona, Spain
Research Site	Recruiting
Sevilla, Spain

Sponsors and Collaborators

EMD Serono

ZymoGenetics

Investigators

Study Director:

Bruno Musch, MD PhD

Merck Serono International, SA, an affiliate of Merck KgaA, Darmstadt, Germany

More Information

Responsible Party:	Merck Serono International S.A. An affiliate of Merck KGaA, Darmstadt, Germany ( Frederic Monnot )
Study ID Numbers:	28156
Study First Received:	February 15, 2008
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00624468
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Papillitis
Neuromuscular Diseases
Eye Diseases
Peripheral Nervous System Diseases

Optic Nerve Diseases
Optic nerve disorder
Optic Neuritis
Neuritis

Additional relevant MeSH terms:

Nervous System Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on January 16, 2009