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ECU-MG-302: An Extension Trial of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis

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ClinicalTrials.gov Identifier: NCT02301624
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Brief Summary:
To evaluate the safety and efficacy of eculizumab in the treatment of refractory gMG as an extension trial for the subjects who have participated in the ECU-MG-301 trial.

Condition or disease Intervention/treatment Phase
Refractory Generalized Myasthenia Gravis Biological: Eculizumab Phase 3

Detailed Description:
Trial ECU-MG-302 is an extension trial designed to provide the subjects who participated in the ECU-MG-301 trial an opportunity to receive eculizumab and to collect clinical data that will provide long term safety and efficacy information on eculizumab in subjects with refractory gMG.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ECU-MG-302, 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)
Study Start Date : November 2014
Actual Primary Completion Date : March 8, 2019
Actual Study Completion Date : March 8, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Eculizumab

Arm Intervention/treatment
Experimental: Eculizumab
See interventions
Biological: Eculizumab
Open-Label eculizumab 1200mg IV every 2 weeks




Primary Outcome Measures :
  1. Long-term safety and tolerability of eculizumab (assessed based on adverse events, vital signs, laboratory assessments, physical exams and ECGs) [ Time Frame: End of Study (Week 208) - Duration of Study ]
    The safety of eculizumab will be assessed based on adverse events, vital signs, laboratory assessments, physical exams and ECGs


Secondary Outcome Measures :
  1. Total MG-ADL score [ Time Frame: End of Study (Week 208) - Duration of Study ]
    Improvement or maintenance of the MG-ADL Score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301624


Sponsors and Collaborators
Alexion Pharmaceuticals
Investigators
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Study Director: Marcus Yountz, MD Alexion Pharmaceuticals

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02301624     History of Changes
Other Study ID Numbers: ECU-MG-302
2013-002191-41 ( EudraCT Number )
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Keywords provided by Alexion Pharmaceuticals:
gMG
Myasthenia Gravis
safety
efficacy
Additional relevant MeSH terms:
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Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases