Clinical trial NCT00624468: Atacicept in Subjects With Optic Neuritis
Official title: A Two-arm, Randomized, 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Optic Neuritis
Keywords: atacicept
neuritis
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2008-02-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of unilateral symptomatic optic neuritis as first clinical manifestation within 28 days between onset of symptoms and study Day 1
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Pre treatment with immunosuppressants and immunomodulating drugs
* Relevant cardiac, hepatic and renal diseases
* Clinical significant abnormalities in blood cell counts and immunoglobulin levels
* Clinical significant acute or chronic infections
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)
timeFrame: Baseline, LOV (Week 48)
Secondary outcomes:
measure: Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye
timeFrame: Weeks 12, 24 and 36
measure: Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24
timeFrame: Baseline, Weeks 12 and 24
measure: Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36
timeFrame: Baseline, Weeks 12, 24 and 36
measure: Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36
timeFrame: Baseline, Weeks 12, 24 and 36
measure: Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36
timeFrame: Baseline, Weeks 12, 24 and 36
measure: Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified
timeFrame: Weeks 12, 24 and 36
measure: Contrast Sensitivity: Total Number of Letters Correctly Identified
timeFrame: Weeks 12, 24 and 36
measure: Contrast Sensitivity: Score Line
timeFrame: Weeks 12, 24 and 36
measure: Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack
timeFrame: From baseline (Study Day 1) up to Week 36
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Fairfield
country: United States
facility: Research Site
state: Connecticut
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: East Lansing
country: United States
facility: Research Site
state: Michigan
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Houston
country: United States
facility: Research Site
state: Texas
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Parkville
country: Australia
facility: Research Site
state: Victoria
city: Bruxelles
country: Belgium
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Munich
country: Germany
facility: Research Site
city: Tübingen
country: Germany
facility: Research Site
city: Würzburg
country: Germany
facility: Research Site
city: Beyrouth
country: Lebanon
facility: Research Site
city: Dbayeh
country: Lebanon
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: