EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001151-12-AT

Enrollment

132

Registered

2014-02-14

Start date

2014-07-23

Completion date

Unknown

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuromyelitis Optica MedDRA version: 20.0 Level: LLT Classification code 10029322 Term: Neuromyelitis optica System Organ Class: 100000004852

Interventions

Trade Name: SOLIRIS Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ECULIZUMAB CAS Number: 219685-50-4 Current Sponsor code: h5G1.1-mAb Concentration unit: mg/ml millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female patient = 18 years old - Patient who completed the ECU-NMO-301 trial - Patients who completed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 119 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13

Exclusion criteria

Exclusion criteria: - Patient withdrew 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 - Any medical condition or circumstances that, in the opinion of the Investigator, might interfere with the patient’s participation in the trial, pose any added risk for the patient, or confound the assessment of the patients.

Design outcomes

Primary

Measure	Time frame
Main Objective: Long-term safety of eculizumab in patients with relapsing NMO. ;Secondary Objective: Long-term efficacy of eculizumab in patients with relapsing NMO Describe the pharmacokinetics (PK) and pharmacodynamics (PD) of eculizumab in relapsing NMO patients. ;Primary end point(s): - Safety: Trial emergent adverse effects;Timepoint(s) of evaluation of this end point: Trial period	—

Secondary

Measure	Time frame
Secondary end point(s): - On-Trial relapse - EDSS and mRS score change from baseline - FSS score - Quality of life;Timepoint(s) of evaluation of this end point: Evaluation at: - Blind induction phase (day 1, week 4) - Open label phase (week 8, 12, 26, 40, 52, 66, 78, 92, 116, 130, 144, 170, 182, 196) - Relapse Evaluation Visits (within 48 hours, and at week +1, 4 weeks, 6 weeks after relapse) - End of trial visit (week 104 or 156 or 208)	—

Measure

Time frame

Secondary end point(s): - On-Trial relapse - EDSS and mRS score change from baseline - FSS score - Quality of life;Timepoint(s) of evaluation of this end point: Evaluation at: - Blind induction phase (day 1, week 4) - Open label phase (week 8, 12, 26, 40, 52, 66, 78, 92, 116, 130, 144, 170, 182, 196) - Relapse Evaluation Visits (within 48 hours, and at week +1, 4 weeks, 6 weeks after relapse) - End of trial visit (week 104 or 156 or 208)

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Republic of, Netherlands, Peru, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom, United States

Contacts

Public ContactEuropean Clinical Trial Information

ALEXION EUROPE SAS

clinicaltrials.eu@alexion.com+33147100615

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026