Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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28 February 2019 |
Main ID: |
EUCTR2013-002191-41-BE |
Date of registration:
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02/09/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS
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Scientific title:
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A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) |
Date of first enrolment:
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17/10/2014 |
Target sample size:
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92 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002191-41 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Induction blinded phase followed by an open label maintenance phase
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Canada
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Greece
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Hungary
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Ireland
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Italy
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Japan
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Netherlands
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Norway
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Spain
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Sweden
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Switzerland
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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European Clinical Trial Information
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Address:
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1-15 avenue Edouard Belin
92500
Rueil-Malmaison
France |
Telephone:
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+33147100606 |
Email:
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clinicaltrials.eu@alxn.com |
Affiliation:
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ALEXION EUROPE SAS |
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Name:
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European Clinical Trial Information
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Address:
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1-15 avenue Edouard Belin
92500
Rueil-Malmaison
France |
Telephone:
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+33147100606 |
Email:
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clinicaltrials.eu@alxn.com |
Affiliation:
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ALEXION EUROPE SAS |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Subject has completed the ECU-MG-301 trial.
2. Subject has given written informed consent.
3. Subject is willing and able to comply with the protocol requirements for the duration of the trial.
4. Female subjects of child-bearing potential must have a negative pregnancy test (serum human chorionic gonadotropin [HCG]). All subjects must practice an effective, reliable and medically approved contraceptive regimen during the trial and for up to 5 months following discontinuation of treatment. 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 83 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria: 1. Subjects who withdrew from the ECU-MG-301 trial as a result of an AE related to trial drug.
2. Female subjects who are pregnant, breastfeeding or intend to conceive during the course of the trial.
3. Any medical condition or circumstances that, in the opinion of the Investigator, might interfere with the subject’s participation in the trial, pose any added risk for the subject, or confound the assessment of the subjects.
4. Unresolved meningococcal infection
5. Hypersensitivity to murine proteins or to one of the excipeints of eculizumab
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Generalized Myasthenia Gravis
MedDRA version: 18.0
Level: HLT
Classification code 10071942
Term: Myasthenia gravis and related conditions
System Organ Class: 100000004859
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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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 milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Secondary Objective: - To evaluate the long-term efficacy of eculizumab in subjects with refractory gMG as measured by the improvement or maintenance of the MG-specific Activities of Daily Living profile (MG-ADL). - To evaluate the long-term efficacy of eculizumab by additional efficacy measures including: Quantitative Myasthenia Gravis (QMG) score, Myasthenia Gravis Composite (MGC) score, and Improvement or maintenance in primary symptoms that are most clinically meaningful to the subjects. - To characterize the effect of eculizumab on quality of life measures. - To describe the pharmacokinetics (PK) and pharmacodynamics (PD) of eculizumab in subjects with gMG.
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Primary end point(s): Change from baseline in the MG-ADL total score.
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Timepoint(s) of evaluation of this end point: From week 1 to 182
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Main Objective: To evaluate the long-term safety of eculizumab in subjects with refractory gMG.
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Secondary Outcome(s)
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Secondary end point(s): 1. Change from baseline in QMG total score.
2. Proportion of subjects with at least a 3-point reduction in the MG-ADL total score from baseline and with no rescue therapy.
3. Proportion of subjects with at least a 5-point reduction in the QMG total score from baseline and with no rescue therapy.
4. Change from baseline in the MGC scale total score.
5. Change from baseline in MG-QOL-15.
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Timepoint(s) of evaluation of this end point: From week 1 to 182
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Secondary ID(s)
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2013-002191-41-GB
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ECU-MG-302
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Source(s) of Monetary Support
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ALEXION PHARMACEUTICALS INC
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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