CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
1 other identifier
observational
800
1 country
1
Brief Summary
This is a Prospective, observational research study for patients with NMOSD under the care of a licensed neurologist. Approximately 800 patients and 35 clinical sites in North America will be recruited to participate with no defined upper limit for either target.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2021
CompletedFirst Submitted
Initial submission to the registry
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
May 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2099
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2099
February 9, 2026
January 1, 2026
77.7 years
May 10, 2021
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
NMO epidemiology, presentation, natural history, management, and outcomes
The major clinical outcomes include an assessment of the epidemiology of NMO; to better understand the presentation, natural history, management and outcomes.
A minimum of 10 years from last patient enrolled
Secondary Outcomes (14)
Physician reported- MFIS
every 6 months for 10 years
Physician reported-PD-Q
every 6 months for 10 years
Physician reported-EQ-5D-5L
every 6 months for 10 years
Physician reported-SF-MPQ-2
every 6 months for 10 years
Physician reported-Pain Severity NRS
every 6 months for 10 years
- +9 more secondary outcomes
Study Arms (1)
NMO
Pts presenting to enrolling sites across the northern America are invited to enroll if eligible
Eligibility Criteria
Patients are enrolled in the NMOSD Registry during regularly scheduled office visits. Selected neurologist are invited to participate as investigators in the Registry.
You may qualify if:
- Has a diagnosis of NMOSD at the time of enrollment according to the 2015 IPND consensus diagnostic criteria for NMOSD†.
- Age 18 years or older at the time of enrollment.
- Willing to provide Personal Information.
You may not qualify if:
- Has had a clinically confirmed NMOSD neuro-episode within the 12 weeks prior to enrollment.
- Is participating or planning to participate in a double-blind randomized trial for an NMOSD drug. Note: Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.
- All serology types (APQ4 +/- and MOG +/-) are eligible to enroll in the registry given they meet the 2015 IPND diagnostic criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CorEvitaslead
Study Sites (1)
CorEvitas, LLC
Waltham, Massachusetts, 02451, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 15 Years
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 14, 2021
Study Start
April 28, 2021
Primary Completion (Estimated)
January 1, 2099
Study Completion (Estimated)
January 1, 2099
Last Updated
February 9, 2026
Record last verified: 2026-01