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Sponsored by: |
EMD Serono |
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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: Laurence Darmency | +41-22-4149799 | laurence.darmency@merckserono.net |
Study Director: | Dan Mikol, MD, PhD | EMD Serono |
Responsible Party: | Merck Serono S.A. - Geneva an Affiliate of Merck KGaA, Darmstadt, Germany ( Laurence Darmency ) |
Study ID Numbers: | 28156 |
Study First Received: | February 15, 2008 |
Last Updated: | August 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00624468 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Papillitis Neuromuscular Diseases Optic Nerve Disorder Eye Diseases |
Peripheral Nervous System Diseases Optic Nerve Diseases Optic Neuritis Neuritis |
Neuromuscular Diseases Eye Diseases Peripheral Nervous System Diseases Nervous System Diseases |
Optic Nerve Diseases Cranial Nerve Diseases Optic Neuritis Neuritis |