CompletedPhase 3

An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients

United States, Argentina, Australia119 participantsStarted 2015-01-12

Plain-language summary

The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient completed the ECU-NMO-301 trial
. Patient has given written informed consent

Exclusion criteria

. Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial drug
. Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

Timeframe: Baseline up to end of study (up to 6.5 years)

Number of Participants With At Least 1 Post Baseline Columbia-Suicide Severity Rating Scale (C-SSRS) Assessment (Suicide-Related Thoughts or Behaviours) Abnormality

Timeframe: Baseline up to end of study (up to 6.5 years)

Number of Participants With An On-trial Relapse as Determined by The Treating Physician

Timeframe: Baseline up to end of study (up to 6.5 years)

On-Trial Annualized Relapse Rate (ARR) as Determined by The Treating Physician

Timeframe: Baseline up to end of study (up to 6.5 years)

Trial details

NCT IDNCT02003144

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-12

Results submitted2022-06-13

View on ClinicalTrials.gov More Neuromyelitis Optica trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient completed the ECU-NMO-301 trial
. Patient has given written informed consent

Exclusion criteria

. Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial drug
. Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial

What they're measuring

Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

Timeframe: Baseline up to end of study (up to 6.5 years)

Number of Participants With At Least 1 Post Baseline Columbia-Suicide Severity Rating Scale (C-SSRS) Assessment (Suicide-Related Thoughts or Behaviours) Abnormality

Timeframe: Baseline up to end of study (up to 6.5 years)

Number of Participants With An On-trial Relapse as Determined by The Treating Physician

Timeframe: Baseline up to end of study (up to 6.5 years)

On-Trial Annualized Relapse Rate (ARR) as Determined by The Treating Physician

Timeframe: Baseline up to end of study (up to 6.5 years)