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Enrolling by Invitation

NCT Number: NCT04886492

CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)

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.

Enrolling by Invitation

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Physician reported- MFIS

    Time frame: every 6 months for 10 years

  2. Physician reported-PD-Q

    Time frame: every 6 months for 10 years

  3. Physician reported-EQ-5D-5L

    Time frame: every 6 months for 10 years

  4. Physician reported-SF-MPQ-2

    Time frame: every 6 months for 10 years

  5. Physician reported-Pain Severity NRS

    Time frame: every 6 months for 10 years

  6. Physician reported-PHQ-2

    Time frame: every 6 months for 10 years

  7. Physician reported-Caregiver status

    Time frame: every 6 months for 10 years

  8. Physician reported - NMOSD Disability Index

    Time frame: every 6 months for 10 years

  9. Physician reported - NEI VFQ-UI

    Time frame: every 6 months for 10 years

  10. Physician reported - TSQM-9

    Time frame: every 6 months for 10 years

  11. Patient reported - EDSS-NMOSD Module

    Time frame: every 6 months for 10 years

  12. Patient reported - MoCA

    Time frame: every 6 months for 10 years

  13. Percentage of patients with history of comorbidities

    Time frame: every 6 months for 10 years

  14. Relapse History

    Time frame: every 6 months for 10 years

Sponsors and collaborators

Lead sponsor

CorEvitas

Network

Registry information

Important dates

Study start
2021
Primary completion
2099
Study completion
2099
First posted
May 14, 2021
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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