Status:
COMPLETED
An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Alexion Pharmaceuticals, Inc.
Conditions:
Neuromyelitis Optica
Devic's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if the drug eculizumab reduces the attack rate and improves outcome in patients with neuromyelitis optica.
Detailed Description
It has been shown in some scientific studies that the the antibody marker specific for neuromyelitis optica (NMO), known as NMO-Immunoglobulin G (IgG), causes inflammation in brain tissues by activati...
Eligibility Criteria
Inclusion
- Diagnosis of NMO, as defined by 2006 criteria OR NMO seropositive spectrum disorder (Recurrent ON or longitudinally extensive transverse myelitis (LETM)). All patients must be NMO-IgG seropositive.
- Clinical evidence of at least 2 relapses in last 6 months or 3 relapses in the last 12 months (with at least 1 relapse occurring in the preceding 6 months).
- Age ≥18 years
- Corrected visual acuity 20/100 or better in at least one eye. If fails item # 4 then entry allowed but only if last attack was myelitis and only attacks of myelitis are considered as outcome measurement.
- Ambulatory (with or without walker). If fails item # 5 then entry allowed but only if last attack was ON and only attacks of ON are considered as outcome measurement.
- Provision of written informed consent (see attached) to participate in the study.
- N. meningitidis vaccination at least 14 days prior to receiving the first eculizumab infusion. If patient in midst of an acute relapse, then relapse will be treated with standard therapy and vaccination given only after a minimum of 4 weeks post attack onset.
Exclusion
- Candidates will be excluded from study entry if any of the following criteria are met at the time of randomization:
- Progressive neurological deterioration unrelated to relapses of ON or myelitis.
- Pregnant, breastfeeding, or intending to conceive during the course of the study
- Patients will not participate in any other clinical therapeutic study or will not have participated in any other experimental treatment study within 30 days of screening
- Patients with a history of splenectomy, because of a potential increased risk of developing meningococcal infection.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00904826
Start Date
April 1 2009
End Date
December 1 2011
Last Update
November 4 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic
Rochester, Minnesota, United States, 55905