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Completed Phase 3 Interventional Results available

Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)

ClinicalTrials.gov ID: NCT01997229

Public ClinicalTrials.gov record NCT01997229. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 2:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Study identification

NCT ID
NCT01997229
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Alexion Pharmaceuticals, Inc.
Industry
Enrollment
125 participants

Conditions and interventions

Interventions

  • Eculizumab Biological
  • Placebo Drug

Biological · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2013
Primary completion
Jan 31, 2016
Completion
May 31, 2016
Last update posted
Jul 15, 2019

2013 – 2016

United States locations

U.S. sites
41
U.S. states
23
U.S. cities
38
Facility City State ZIP Site status
University of Alabama Birmingham Alabama 35233
University of California San Francisco-Fresno Fresno California 93720
University of Southern California Los Angeles California 90033
University of California-Irvine Orange California 92868
University of California Davis Health System Sacramento California 95765
California Pacific Medical Center San Francisco California 94115
Stanford University School of Medicine Stanford California 94305
Yale New Haven Hospital New Haven Connecticut 06510
University of Florida Health Science Center Jacksonville Florida 32209
University of Miami School of Medicine Miami Florida 33136
University of South Florida Tampa Florida 33612
Georgia Regents University Augusta Georgia 30912
Medical Associates of North Georgia Canton Georgia 30114
Southern Illinois University School of Medicine Springfield Illinois 62702
Indiana University Indianapolis Indiana 46202
University of Iowa College of Medicine Iowa City Iowa 52242
University of Kansas Medical Center Kansas City Kansas 66160
University of Maryland Medical Center Baltimore Maryland 21201
Johns Hopkins University School Of Medicine Baltimore Maryland 21287-0876
Massachusetts General Hospital Boston Massachusetts 02114
Brigham and Women's Hospital Boston Massachusetts 02115
Lahey Clinic Inc. Burlington Massachusetts 01805
Wayne State University School of Medicine Detroit Michigan 48201
Las Vegas Clinic Las Vegas Nevada 89145
Buffalo General Hospital Buffalo New York 14203
Hospital For Special Surgery/New York Presbyterian Hospital Cornell Campus New York New York 10021
Mount Sinai School of Medicine New York New York 10029
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599
Carolinas Healthcare System Charlotte North Carolina 28207
Duke University Health System Durham North Carolina 27705
Ohio State University Medical Center Columbus Ohio 43210
Oregon Health & Science University Portland Oregon 97239
University of Pennsylvania Philadelphia Pennsylvania 19104
Rhode Island Hospital Providence Rhode Island 02905
Wesley Neurology Clinic Cordova Tennessee 38018
Vanderbilt Medical Center Nashville Tennessee 37232
UT Southwestern Dallas Texas 75390
Methodist Neurological Institute Houston Texas 77030
University of Texas Health Science Center at San Antonio San Antonio Texas 78229
University of Vermont Medical Center Burlington Vermont 05405
University of Washington Seattle Washington 98195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 73 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01997229, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 15, 2019 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01997229 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →