Neuromyelitis Optica Spectrum DisorderNCT04886492
CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
An observational study of Neuromyelitis Optica Spectrum Disorder, run by CorEvitas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorder
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to Jan 2099
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients are enrolled in the NMOSD Registry during regularly scheduled office visits. Selected neurologist are invited to participate as investigators in the Registry.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
The objective of the registry is to create a cohort of patients with NMOSD. Data collected will be used to prospectively study the natural history of NMOSD, real-word effectiveness and safety of medications used to treat NMOSD, and drug utilization treatment patterns. Additionally, the data will be used to systematically evaluate the burden for patients with NMOSD and the impact of therapies on quality of life. This will be done through real time capture and adjudication of relapses, the standardized collection of patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns.
Personal information is also collected from each consenting registry patient allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of NMOSD for the purposes of clinical, market, or outcomes research. This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and patient adherence.
Consent for additional ad hoc surveys will be solicited which can allow evaluation of additional aspects of the disease impact such as care giver burden or impact of disease on productivity.
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NMO | Pts presenting to enrolling sites across the northern America are invited to enroll if eligible |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A minimum of 10 years from last patient enrolled
Secondary outcomes (14)
Physician reported- MFIS
Measured: every 6 months for 10 years
Physician reported-PD-Q
Measured: every 6 months for 10 years
Physician reported-EQ-5D-5L
Measured: every 6 months for 10 years
Physician reported-SF-MPQ-2
Measured: every 6 months for 10 years
Physician reported-Pain Severity NRS
Measured: every 6 months for 10 years
Physician reported-PHQ-2
Measured: every 6 months for 10 years
Physician reported-Caregiver status
Measured: every 6 months for 10 years
Physician reported - NMOSD Disability Index
Measured: every 6 months for 10 years
Physician reported - NEI VFQ-UI
Measured: every 6 months for 10 years
Physician reported - TSQM-9
Measured: every 6 months for 10 years
Patient reported - EDSS-NMOSD Module
Measured: every 6 months for 10 years
Patient reported - MoCA
Measured: every 6 months for 10 years
Percentage of patients with history of comorbidities
Measured: every 6 months for 10 years
Relapse History
Measured: every 6 months for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start28 Apr 2021
- Primary completionJan 2099 (estimated)
- Study completionJan 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886492
- Sponsor's protocol ID
- NMOSD-750
- Status last verified
- Jan 2026
- First submitted
- 10 May 2021
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
- ClinicalTrials.gov ID
- NCT04886492
- Acronym / sponsor ID
- NMOSD-750
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- Jan 2099 (estimated)
- Study completion
- Jan 2099 (estimated)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of the registry is to create a cohort of patients with NMOSD. Data collected will be used to prospectively study the natural history of NMOSD, real-word effectiveness and safety of medications used to treat NMOSD, and drug utilization treatment patterns. Additionally, the data will be used to systematically evaluate the burden for patients with NMOSD and the impact of therapies on quality of life. This will be done through real time capture and adjudication of relapses, the standardized collection of patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns.
Personal information is also collected from each consenting registry patient allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of NMOSD for the purposes of clinical, market, or outcomes research. This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and patient adherence.
Consent for additional ad hoc surveys will be solicited which can allow evaluation of additional aspects of the disease impact such as care giver burden or impact of disease on productivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NMO | – | –Pts presenting to enrolling sites across the northern America are invited to enroll if eligible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients are enrolled in the NMOSD Registry during regularly scheduled office visits. Selected neurologist are invited to participate as investigators in the Registry.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NMO epidemiology, presentation, natural history, management, and outcomes
Time frame: A minimum of 10 years from last patient enrolled
The major clinical outcomes include an assessment of the epidemiology of NMO; to better understand the presentation, natural history, management and outcomes.
14 secondary outcomes
Physician reported- MFIS
Time frame: every 6 months for 10 years
Physician reported-PD-Q
Time frame: every 6 months for 10 years
Physician reported-EQ-5D-5L
Time frame: every 6 months for 10 years
Physician reported-SF-MPQ-2
Time frame: every 6 months for 10 years
Physician reported-Pain Severity NRS
Time frame: every 6 months for 10 years
Physician reported-PHQ-2
Time frame: every 6 months for 10 years
Physician reported-Caregiver status
Time frame: every 6 months for 10 years
Physician reported - NMOSD Disability Index
Time frame: every 6 months for 10 years
Physician reported - NEI VFQ-UI
Time frame: every 6 months for 10 years
Physician reported - TSQM-9
Time frame: every 6 months for 10 years
Patient reported - EDSS-NMOSD Module
Time frame: every 6 months for 10 years
Patient reported - MoCA
Time frame: every 6 months for 10 years
Percentage of patients with history of comorbidities
Time frame: every 6 months for 10 years
Relapse History
Time frame: every 6 months for 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromyelitis Optica Spectrum Disorder, run by CorEvitas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NMO epidemiology, presentation, natural history, management, and outcomes (time frame: A minimum of 10 years from last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.