Atacicept in Subjects With Optic Neuritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00624468
• Date of registration: 15/02/2008
• Prospective Registration: Yes
• Primary sponsor: EMD Serono
• Public title: Atacicept in Subjects With Optic Neuritis
• Scientific 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
• Date of first enrolment: June 2008
• Target sample size: 34
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00624468
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Canada, Czech Republic, France, Germany, Lebanon, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Medical Responsible
• Affiliation: EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Optic Neuritis

Intervention(s)

Drug: Placebo matched to atacicept

Drug: Atacicept

Primary Outcome(s)

Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV) [Time Frame: Baseline, LOV (Week 48)]

Secondary Outcome(s)

Contrast Sensitivity: Score Line [Time Frame: Weeks 12, 24 and 36]

Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack [Time Frame: From baseline (Study Day 1) up to Week 36]

Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 [Time Frame: Baseline, Weeks 12, 24 and 36]

Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 [Time Frame: Baseline, Weeks 12, 24 and 36]

Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24 [Time Frame: Baseline, Weeks 12 and 24]

Contrast Sensitivity: Total Number of Letters Correctly Identified [Time Frame: Weeks 12, 24 and 36]

Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye [Time Frame: Weeks 12, 24 and 36]

Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36 [Time Frame: Baseline, Weeks 12, 24 and 36]

Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified [Time Frame: Weeks 12, 24 and 36]

Secondary ID(s)

28156

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck KGaA

Results

• Results available: Yes
• Date Posted: 17/02/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00624468