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Sponsors and Collaborators: |
EMD Serono ZymoGenetics |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00624468 |
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 |
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Optic Neuritis |
Drug: Atacicept Drug: Placebo |
Phase II |
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 |
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 |
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1: Experimental
Atacicept 150 mg
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Drug: Atacicept
Atacicept s.c. QW
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2: Placebo Comparator
Placebo
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Drug: Placebo
Matching Placebo
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other differential diagnoses
Contact: Frederic Monnot, PharmD | +41 22 414 3376 | Frederic.monnot@merckserono.net |
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 |
Study Director: | Bruno Musch, MD PhD | Merck Serono International, SA, an affiliate of Merck KgaA, Darmstadt, Germany |
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 |
Papillitis Neuromuscular Diseases Eye Diseases Peripheral Nervous System Diseases |
Optic Nerve Diseases Optic nerve disorder Optic Neuritis Neuritis |
Nervous System Diseases Cranial Nerve Diseases |