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A Study to Examine the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients With Symptomatic Generalized Myasthenia Gravis (NIMBLE)

Primary Purpose

Generalized Myasthenia Gravis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pozelimab + Cemdisiran
Cemdisiran
Placebo
Pozelimab
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Myasthenia Gravis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Male or female patients ≥18 years of age at screening (or ≥ legal age of adulthood based on local regulations, whichever is older)
  2. Patient with documented diagnosis of myasthenia gravis (MG) based on medical history and supported by previous evaluations as described in the protocol
  3. Documented prior history of positive serologic test or a positive result during screening of anti-acetylcholine receptor (AChR) antibodies or anti-LRP4 antibodies.
  4. Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IVa at screening
  5. Myasthenia Gravis-Activities of Daily Living (MG-ADL) score ≥6 at screening. Ocular items should not contribute more than 50% of MG-ADL total score
  6. Currently receiving an acetylcholinesterase inhibitor or documented reason for not using acetylcholinesterase inhibitor therapy per investigator 7. Currently receiving an immunosuppressive therapy (IST) for MG, or documented reason why the patient is not taking an IST per investigator

8. If currently receiving an IST, not anticipated to have IST dosage changed before randomization or during double-blind treatment period (DBTP).

Key Exclusion Criteria:

  1. Patients with antibody profile that is only positive for muscle specific tyrosine kinase (MuSK) (MuSK positivity is based on a documented prior history of positive serologic test for antibodies to MuSK or a positive result during screening
  2. History of thymectomy within 12 months prior to screening or planned during the study
  3. History of malignant thymoma (patients with stage 1 may be enrolled), or history of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer
  4. Myasthenic crisis or Myasthenia Gravis Foundation of America (MGFA) Class V within 1 month of screening
  5. No documented meningococcal vaccination within 5 years prior to screening visit unless vaccination will be administered during the screening period and prior to initiation of study treatment
  6. Known contraindication to meningococcal vaccines (group ACWY conjugate and group B vaccines) as described in the protocol
  7. Patients who require antibiotics for meningococcal prophylaxis and have a contraindication, warning, or precaution precluding the use of penicillin class and penicillin-alternative antibiotics planned to be used for prophylaxis, or a history of intolerance leading to the discontinuation of these antibiotics
  8. Positive hepatitis B surface antigen or hepatitis C virus ribonucleic acid (RNA) during screening. NOTE: Cases with unclear interpretation should be discussed with the medical monitor
  9. History of HIV infection or a positive test at screening per local requirements

NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Sites / Locations

  • HonorHealth NeurologyRecruiting
  • University of California, IrvineRecruiting
  • University of Southern CaliforniaRecruiting
  • Colorado Springs Neurological AssociatesRecruiting
  • SFM Clinical Research, LLCRecruiting
  • Diverse Clinical ResearchRecruiting
  • Collier Neurologic Specialists LLCRecruiting
  • Neurological Services of OrlandoRecruiting
  • Medsol Clinical Research Center IncRecruiting
  • University of South FloridaRecruiting
  • Northwestern University
  • NorthShore University Health SystemRecruiting
  • Prairie Education and Research CooperativeRecruiting
  • Northwest Neurology Ltd. - Clinedge - PPDS
  • Wayne State University School of MedicineRecruiting
  • Weill Cornell Medicine - Peripheral Neuropathy CenterRecruiting
  • Atrium Health Neurosciences Institute Charlotte, a facility of Carolinas Medical Center
  • Dayton center for neurological disordersRecruiting
  • University Of Cincinnati Gardner Neuroscience instituteRecruiting
  • Penn Medicine University CityRecruiting
  • Texas Institute for Neurological Disorders - ArlingtonRecruiting
  • Austin Neuromuscular CenterRecruiting
  • Nerve and Muscle Center of TexasRecruiting
  • Southern Neurology
  • Lyell McEwin Hospital
  • St Vincents Hospital Melbourne
  • Perron Institute for Neurological and Translational Science
  • UZ AntwerpenRecruiting
  • Chu Charleroi
  • AZ Sint-LucasRecruiting
  • Université Libre de Bruxelles - Hôpital Erasme
  • University of Alberta
  • London Health Sciences CentreRecruiting
  • Toronto General Hospital
  • Centre Hospitalier de l'Universite de Montreal (CHUM)
  • Fakultni Nemocnice Brno
  • Fakultni nemocnice Ostrava
  • Aalborg UniversitetshospitalRecruiting
  • Aarhus University HospitalRecruiting
  • Copenhagen Neuromuscular Clinic at RigshospitaletRecruiting
  • Odense Universitetshospital - Infektionsmedicinsk AfdelingRecruiting
  • Centre Hospitalier Universitaire (CHU) de NiceRecruiting
  • CHU BicêtreRecruiting
  • Hôpital de la Pitié SalpétrièreRecruiting
  • Centre Hospitalier Regional Universitaire (CHRU) de NancyRecruiting
  • Israeli-Georgian Medical Research Clinic HEALTHYCORE
  • LTD New Hospitals
  • Pineo Medical EcosystemRecruiting
  • LTD Academician N. Kipshidze Central University Clinic
  • Multiprofile Clinic Consilium Medulla
  • Friedrich-Baur-Institute Dep. of Neurology Klinikum Munchen
  • Universitatsklinikum MunsterRecruiting
  • Universitatsklinikum LeipzigRecruiting
  • Charite - Universitatsmedizin BerlinRecruiting
  • University Hospital Essen, Dep. of Neurology
  • Universitatsklinikum JenaRecruiting
  • Government General Hospital, GunturRecruiting
  • Institute Of NeuroSciencesRecruiting
  • Nizam's Institute of Medical Sciences (NIMS)
  • Kasturba Medical College (KMC) - UdupiRecruiting
  • Jubilee Mission HospitalRecruiting
  • Amrita Institute of Medical Sciences (AIMS) and Research CentreRecruiting
  • Deenanath Mangeshkar Hospital and Research CentreRecruiting
  • Seth G.S. Medical College & K.E.M. Hospital, MumbaiRecruiting
  • Polakulath Narayanan Renai Medicity Multi Specialty Hospital, Kochi
  • Christian Medical College & Hospital
  • Apex Hospital
  • City Neuro Centre, HyderabadRecruiting
  • Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
  • Bangalore Medical College and Research Institute (BMCRI) - Victoria HospitalRecruiting
  • Postgraduate Institute of Medical Education & ResearchRecruiting
  • All India Institute of Medical Sciences New DelhiRecruiting
  • Universita' Degli Studi La SapienzaRecruiting
  • Azienda Ospedaliera Sant'andreaRecruiting
  • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo BestaRecruiting
  • IRCCS Mondino Foundation
  • Azienda Ospedaliero Universitaria PisanaRecruiting
  • Azienda Ospedaliera Papa Giovanni XXIII
  • AORN Cardarelli Napoli
  • Kobe City Medical Center General HospitalRecruiting
  • Kochi Medical School HospitalRecruiting
  • Okinawa National HospitalRecruiting
  • Saitama Medical University, Saitama Medical CenterRecruiting
  • Showa General Hospital
  • Medical Hospital of Tokyo Medical and Dental UniversityRecruiting
  • Nihon University Itabashi HospitalRecruiting
  • Tokyo Medical University HospitalRecruiting
  • Yamaguchi University HospitalRecruiting
  • Chiba University HospitalRecruiting
  • Hiroshima City Hiroshima CitizRecruiting
  • Osaka Red Cross Hospital - NeurologyRecruiting
  • Okinawa Prefectural Nanbu Medical Center and Children's Medical CenterRecruiting
  • Samsung Medical Center - PPDSRecruiting
  • Kyungpook National University Chilgok HospitalRecruiting
  • Centrum Neurologii Klinicznej, Krakowska Akademia NeurologiiRecruiting
  • NeuroProtectRecruiting
  • Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital KlinicznyRecruiting
  • Gdanski Uniwersytet MedycznyRecruiting
  • NZOZ Neuro-kardRecruiting
  • Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia, Medic-R Spólka KomandytowaRecruiting
  • University Clinical Center of Serbia - PPDS
  • University Clinical Centre Nis
  • Hospital de La Santa Creu i Sant PauRecruiting
  • Hospital Universitario La Paz - PPDSRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • Shin Kong Wu Ho Su Memorial HospitalRecruiting
  • Chang Gung Memorial HospitalRecruiting
  • Dokuz Eylul University Medical FacultyRecruiting
  • Kocaeli University HospitalRecruiting
  • Ondokuz Mayis Universitesi Tip Fakultesi HastanesiRecruiting
  • Karadeniz Technical University Farabi HospitalRecruiting
  • Sheffield Teaching Hospital NHS Foundation Trust
  • University Hospital BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Placebo in DBTP; Re-randomized to Combination or Cemdisiran in ETP and OLTP

Combination regimen throughout the study

Cemdisiran throughout the study

Pozelimab monotherapy in DBTP followed by combination in ETP and OLTP

Outcomes

Primary Outcome Measures

Change in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score
The total MG-ADL score ranges from 0 to 24 points, with higher scores indicating greater functional impairment and disability

Secondary Outcome Measures

Change from baseline in Quantitative Myasthenia Gravis (QMG) score
QMG total scores range from 0 to 39, with higher scores representing greater impairment
Proportion of patients responding on the MG-ADL
≥3-point improvement
Proportion of patients responding on the QMG
≥5-point improvement
Proportion of patients with consistent response on the MG-ADL
At least a 2-point MG-ADL improvement on 2 or more consecutive assessments spanning 4 or more weeks during the DBTP
Proportion of patients with minimal symptom expression (MSE)
Score of 0 to 1 on the MG-ADL
Change from baseline in the Myasthenia Gravis Composite (MGC) total score
MGC score ranges from 0 to 50, with higher score indicating higher impairment
Change from baseline in Myasthenia Gravis Quality of Life (MG QOL15r) total score
Total score ranges from 0 to 30 points; a higher score represents greater impairment
Proportion of patients with improvement point thresholds on MG-ADL
≥2, 4, 5, 6, 7, 8, 9, or 10
Proportion of patients with improvement point thresholds on QMG
≥3, 4, 6, 7, 8, 9, or 10
Incidence and severity of treatment-related adverse events (TEAEs) in patients treated with pozelimab + cemdisiran or placebo
Incidence and severity of serious adverse events (SAEs) in patients treated with pozelimab + cemdisiran or placebo
Incidence and severity of adverse events of special interest (AESIs) in patients treated with pozelimab + cemdisiran or placebo
Concentrations of total pozelimab in serum
Concentrations of cemdisiran and its metabolites in plasma
Incidence of treatment-emergent anti-drug antibodies (ADAs) to pozelimab over time
Incidence of treatment-emergent ADAs to cemdisiran over time
Change in CH50 over time
Percent change in CH50 over time

Full Information

First Posted
September 27, 2021
Last Updated
October 12, 2023
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05070858
Brief Title
A Study to Examine the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients With Symptomatic Generalized Myasthenia Gravis
Acronym
NIMBLE
Official Title
Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Symptomatic Generalized Myasthenia Gravis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
August 14, 2024 (Anticipated)
Study Completion Date
May 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective is: To evaluate the effect of pozelimab + cemdisiran on daily functioning that is impacted by signs and symptoms in patients with symptomatic generalized myasthenia gravis (gMG) The secondary objectives of the study are: To evaluate the effect of pozelimab + cemdisiran (ie, combination) and cemdisiran monotherapy on: Clinician-assessed signs of myasthenia gravis (MG) and muscle strength Daily functioning that is impacted by signs and symptoms in patients with symptomatic gMG (cemdisiran monotherapy only). Proportion of patients with improvements in daily function that is impacted by signs and symptoms of MG Proportion of patients that have improvements in clinician-assessed signs of MG and muscle strength Health related quality of life Proportion of patients with minimal MG symptoms Patient- and clinician-reported signs and symptoms of MG To evaluate the safety and tolerability of pozelimab + cemdisiran and cemdisiran monotherapy To assess the concentration of total pozelimab in serum To assess the concentrations of cemdisiran and its metabolites in plasma To assess the immunogenicity of pozelimab To assess the concentration of total C5 in plasma To assess the immunogenicity of cemdisiran To study the effect of pozelimab + cemdisiran and cemdisiran monotherapy on complement activation
Detailed Description
DBTP- Double blind treatment plan (24 weeks) ETP - Extension treatment plan (28 weeks) OLTP- Open label treatment plan (68 weeks) Off-treatment follow up period (52 weeks)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Myasthenia Gravis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
235 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Placebo in DBTP; Re-randomized to Combination or Cemdisiran in ETP and OLTP
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Combination regimen throughout the study
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Cemdisiran throughout the study
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Pozelimab monotherapy in DBTP followed by combination in ETP and OLTP
Intervention Type
Drug
Intervention Name(s)
Pozelimab + Cemdisiran
Intervention Description
Subcutaneous administration as described in the protocol
Intervention Type
Drug
Intervention Name(s)
Cemdisiran
Other Intervention Name(s)
ALN-CC5
Intervention Description
SC administration as described in the protocol
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
SC administration as described in the protocol
Intervention Type
Drug
Intervention Name(s)
Pozelimab
Other Intervention Name(s)
REGN3918
Intervention Description
SC administration as described in the protocol
Primary Outcome Measure Information:
Title
Change in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score
Description
The total MG-ADL score ranges from 0 to 24 points, with higher scores indicating greater functional impairment and disability
Time Frame
From baseline to week 24
Secondary Outcome Measure Information:
Title
Change from baseline in Quantitative Myasthenia Gravis (QMG) score
Description
QMG total scores range from 0 to 39, with higher scores representing greater impairment
Time Frame
Week 24
Title
Proportion of patients responding on the MG-ADL
Description
≥3-point improvement
Time Frame
From baseline to week 24
Title
Proportion of patients responding on the QMG
Description
≥5-point improvement
Time Frame
From baseline to week 24
Title
Proportion of patients with consistent response on the MG-ADL
Description
At least a 2-point MG-ADL improvement on 2 or more consecutive assessments spanning 4 or more weeks during the DBTP
Time Frame
From baseline to week 24
Title
Proportion of patients with minimal symptom expression (MSE)
Description
Score of 0 to 1 on the MG-ADL
Time Frame
Week 24
Title
Change from baseline in the Myasthenia Gravis Composite (MGC) total score
Description
MGC score ranges from 0 to 50, with higher score indicating higher impairment
Time Frame
Week 24
Title
Change from baseline in Myasthenia Gravis Quality of Life (MG QOL15r) total score
Description
Total score ranges from 0 to 30 points; a higher score represents greater impairment
Time Frame
Week 24
Title
Proportion of patients with improvement point thresholds on MG-ADL
Description
≥2, 4, 5, 6, 7, 8, 9, or 10
Time Frame
From baseline to week 24
Title
Proportion of patients with improvement point thresholds on QMG
Description
≥3, 4, 6, 7, 8, 9, or 10
Time Frame
From baseline to week 24
Title
Incidence and severity of treatment-related adverse events (TEAEs) in patients treated with pozelimab + cemdisiran or placebo
Time Frame
Through week 24
Title
Incidence and severity of serious adverse events (SAEs) in patients treated with pozelimab + cemdisiran or placebo
Time Frame
Through week 24
Title
Incidence and severity of adverse events of special interest (AESIs) in patients treated with pozelimab + cemdisiran or placebo
Time Frame
Through week 24
Title
Concentrations of total pozelimab in serum
Time Frame
Through study duration, approximate 172 weeks
Title
Concentrations of cemdisiran and its metabolites in plasma
Time Frame
Through study duration, approximate 172 weeks
Title
Incidence of treatment-emergent anti-drug antibodies (ADAs) to pozelimab over time
Time Frame
Through study duration, approximately 172 weeks
Title
Incidence of treatment-emergent ADAs to cemdisiran over time
Time Frame
Through study duration, approximate 172 weeks
Title
Change in CH50 over time
Time Frame
Through study duration, approximately 172 weeks
Title
Percent change in CH50 over time
Time Frame
Through study duration, approximately 172 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male or female patients ≥18 years of age at screening (or ≥ legal age of adulthood based on local regulations, whichever is older) Patient with documented diagnosis of myasthenia gravis (MG) based on medical history and supported by previous evaluations as described in the protocol Documented prior history of positive serologic test or a positive result during screening of anti-acetylcholine receptor (AChR) antibodies or anti-LRP4 antibodies. Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IVa at screening Myasthenia Gravis-Activities of Daily Living (MG-ADL) score ≥6 at screening. Ocular items should not contribute more than 50% of MG-ADL total score Currently receiving an acetylcholinesterase inhibitor or documented reason for not using acetylcholinesterase inhibitor therapy per investigator 7. Currently receiving an immunosuppressive therapy (IST) for MG, or documented reason why the patient is not taking an IST per investigator 8. If currently receiving an IST, not anticipated to have IST dosage changed before randomization or during double-blind treatment period (DBTP). Key Exclusion Criteria: Patients with antibody profile that is only positive for muscle specific tyrosine kinase (MuSK) (MuSK positivity is based on a documented prior history of positive serologic test for antibodies to MuSK or a positive result during screening History of thymectomy within 12 months prior to screening or planned during the study History of malignant thymoma (patients with stage 1 may be enrolled), or history of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer Myasthenic crisis or Myasthenia Gravis Foundation of America (MGFA) Class V within 1 month of screening No documented meningococcal vaccination within 5 years prior to screening visit unless vaccination will be administered during the screening period and prior to initiation of study treatment Known contraindication to meningococcal vaccines (group ACWY conjugate and group B vaccines) as described in the protocol Patients who require antibiotics for meningococcal prophylaxis and have a contraindication, warning, or precaution precluding the use of penicillin class and penicillin-alternative antibiotics planned to be used for prophylaxis, or a history of intolerance leading to the discontinuation of these antibiotics Positive hepatitis B surface antigen or hepatitis C virus ribonucleic acid (RNA) during screening. NOTE: Cases with unclear interpretation should be discussed with the medical monitor History of HIV infection or a positive test at screening per local requirements NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Administrator
Phone
844-734-6643
Email
clinicaltrials@regeneron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
HonorHealth Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Levine
Phone
480-258-2863
Email
neuroscienceresearch@honorhealth.com
First Name & Middle Initial & Last Name & Degree
Todd Levine
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Said Beydoun
Phone
323-442-6221
Email
salma.akhter@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Said Beydoun
Facility Name
Colorado Springs Neurological Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907-5307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Adams
Phone
719-473-3272
Email
ladams@csneuro.com
First Name & Middle Initial & Last Name & Degree
Laurence Adams
Facility Name
SFM Clinical Research, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Feinberg
Phone
561-939-0313
Email
research@sfneurology.com
First Name & Middle Initial & Last Name & Degree
Marc Feinberg
Facility Name
Diverse Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Collier Neurologic Specialists LLC
City
Naples
State/Province
Florida
ZIP/Postal Code
34105-8523
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Justiz
Phone
239-529-6780
Email
william@aqualaneresearch.com
Facility Name
Neurological Services of Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-6264
Country
United States
Individual Site Status
Recruiting
Facility Name
Medsol Clinical Research Center Inc
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuan Vu
Phone
813-974-9413
Email
tvu6@usf.edu
First Name & Middle Initial & Last Name & Degree
Tuan Vu
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Withdrawn
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-3137
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandru Barboi
Phone
847-503-4333
Email
rvazquez@northshore.org
First Name & Middle Initial & Last Name & Degree
Alexandru Barboi
Facility Name
Prairie Education and Research Cooperative
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raghav Govindarajan
Phone
618-641-5803
Email
Raghav.govindarajan@hshs.org
First Name & Middle Initial & Last Name & Degree
Raghav Govindarajan
Facility Name
Northwest Neurology Ltd. - Clinedge - PPDS
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008-3154
Country
United States
Individual Site Status
Terminated
Facility Name
Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Rube
Phone
313-966-9407
Email
xjia@med.wayne.edu
Facility Name
Weill Cornell Medicine - Peripheral Neuropathy Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Vo
Phone
212-746-6757
Email
mlv9002@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Mary Vo
Facility Name
Atrium Health Neurosciences Institute Charlotte, a facility of Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Dayton center for neurological disorders
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Recruiting
Facility Name
University Of Cincinnati Gardner Neuroscience institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn Medicine University City
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Institute for Neurological Disorders - Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhagya Boggaram
Phone
903-893-5141
Ext
4924
Email
murbina@texasneurologyinstitute.com
Facility Name
Austin Neuromuscular Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yessar Hussain
Phone
512-920-0140
Email
yessar@austinneuromuscle.com
First Name & Middle Initial & Last Name & Degree
Yessar Hussain
Facility Name
Nerve and Muscle Center of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aziz Shaibani
Phone
713-795-0033
Email
ataher@aol.com
First Name & Middle Initial & Last Name & Degree
Aziz Shaibani
Facility Name
Southern Neurology
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Lyell McEwin Hospital
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Individual Site Status
Suspended
Facility Name
St Vincents Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Suspended
Facility Name
Perron Institute for Neurological and Translational Science
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Suspended
Facility Name
UZ Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Alonso-Jiménez
Phone
3238214423
Ext
3978
Email
alicia.alonso@uza.be
First Name & Middle Initial & Last Name & Degree
Alicia Alonso-Jiménez
Facility Name
Chu Charleroi
City
Lodelinsart
State/Province
Hainaut
ZIP/Postal Code
6042
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
AZ Sint-Lucas
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan De Bleecker
Phone
3292246530
Email
jan.debleecker@azstlucas.be
First Name & Middle Initial & Last Name & Degree
Jan De Bleecker
Facility Name
Université Libre de Bruxelles - Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vera Bril
Phone
416-340-3898
Email
Eduardo.ng@uhn.ca
Facility Name
Centre Hospitalier de l'Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X-0J1
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Fakultni Nemocnice Brno
City
Brno
State/Province
Jihomoravsky Kraj
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
State/Province
Moravskoslezský Kraj
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
Aalborg Universitetshospital
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Izabella Obal
Phone
4597666896
Email
anpp@rn.dk
First Name & Middle Initial & Last Name & Degree
Izabella Obal
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henning Andersen
Phone
4578454250
Email
hennanden@rm.dk
Facility Name
Copenhagen Neuromuscular Clinic at Rigshospitalet
City
Copenhagen
ZIP/Postal Code
3050
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Vissing
Phone
4535452562
Email
john.vissing@regionh.dk
Facility Name
Odense Universitetshospital - Infektionsmedicinsk Afdeling
City
Odense
ZIP/Postal Code
05000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire (CHU) de Nice
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
6002
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital de la Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Demeret
Phone
sophie.demeret@aphp.fr
Facility Name
Centre Hospitalier Regional Universitaire (CHRU) de Nancy
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Name
Israeli-Georgian Medical Research Clinic HEALTHYCORE
City
T'bilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
LTD New Hospitals
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
Pineo Medical Ecosystem
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD Academician N. Kipshidze Central University Clinic
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
Multiprofile Clinic Consilium Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
Friedrich-Baur-Institute Dep. of Neurology Klinikum Munchen
City
Munchen
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsklinikum Munster
City
Munster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Lünemann
Phone
+49 251 83 48165
Email
MS-Studienambulanz@ukmuenster.de
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Then Berg
Phone
+493419724320
Email
studienambulauz.neurologie@medizin.uni-leipzig.de
Facility Name
Charite - Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Essen, Dep. of Neurology
City
Essen
ZIP/Postal Code
45127
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Name
Government General Hospital, Guntur
City
Guntur
State/Province
Andhra Pradesh
ZIP/Postal Code
522001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
N.V. Sundarachary
Phone
9440257675
Email
sundarachary@yahoo.com
Facility Name
Institute Of NeuroSciences
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395001
Country
India
Individual Site Status
Recruiting
Facility Name
Nizam's Institute of Medical Sciences (NIMS)
City
Panjagutta
State/Province
Hyderabad
ZIP/Postal Code
500082
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Kasturba Medical College (KMC) - Udupi
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
576104
Country
India
Individual Site Status
Recruiting
Facility Name
Jubilee Mission Hospital
City
Thrissur
State/Province
Kerala
ZIP/Postal Code
680005
Country
India
Individual Site Status
Recruiting
Facility Name
Amrita Institute of Medical Sciences (AIMS) and Research Centre
City
Kochi
State/Province
Kerela
ZIP/Postal Code
682041
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sudheeran Kannoth
Phone
+91-9947340695
Email
sudheerank@aims.amrita.edu
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahul Kulkarni
Phone
+91 9822012588
Email
rahulneuro@gmail.com
Facility Name
Seth G.S. Medical College & K.E.M. Hospital, Mumbai
City
Parel
State/Province
Mumbai
ZIP/Postal Code
400012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangeeta Ravat
Phone
9967325639
Email
kemneurology@gmail.com
Facility Name
Polakulath Narayanan Renai Medicity Multi Specialty Hospital, Kochi
City
Kochi
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Christian Medical College & Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Apex Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Individual Site Status
Not yet recruiting
Facility Name
City Neuro Centre, Hyderabad
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500034
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rukmini Mridula
Phone
9966449650
Email
saisrimeka@gmail.com
Facility Name
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226014
Country
India
Individual Site Status
Withdrawn
Facility Name
Bangalore Medical College and Research Institute (BMCRI) - Victoria Hospital
City
Bangalore
ZIP/Postal Code
560002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Praveen Kumar
Phone
+919844252189
Email
Harryraykar@yahoo.com
Facility Name
Postgraduate Institute of Medical Education & Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish Modi
Phone
+91 7087572688
Email
priya7chd@gmail.com
Facility Name
All India Institute of Medical Sciences New Delhi
City
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vishnu Vy
Phone
011 2658 9999
Email
vishnuvy16@gmail.com
Facility Name
Universita' Degli Studi La Sapienza
City
Roma
State/Province
Lazio
ZIP/Postal Code
00185
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Inghilleri
Phone
390649914122
Email
maurizio.inghilleri@uniroma1.it
First Name & Middle Initial & Last Name & Degree
Maurizio Inghilleri
Facility Name
Azienda Ospedaliera Sant'andrea
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelangelo Maestri
Phone
39050995519
Email
m.maestri@ao-pisa.toscana.it
First Name & Middle Initial & Last Name & Degree
Michelangelo Maestri
Facility Name
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renato Mantegazza
Phone
390223942282
Ext
2255
Email
renato.mantegazza@istituto-besta.it
First Name & Middle Initial & Last Name & Degree
Renato Mantegazza
Facility Name
IRCCS Mondino Foundation
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
AORN Cardarelli Napoli
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michi Kawamoto
Phone
+80 78 302 4321
Facility Name
Kochi Medical School Hospital
City
Nankoku-shi
State/Province
Koti
ZIP/Postal Code
783-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okinawa National Hospital
City
Ginowan-Shi
State/Province
Okinawa
ZIP/Postal Code
901-2214
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University, Saitama Medical Center
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Showa General Hospital
City
Kodaira
State/Province
Tokoyo
ZIP/Postal Code
187-0002
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Medical Hospital of Tokyo Medical and Dental University
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoichiro Nishida
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Hospital
City
Shinjuku ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima City Hiroshima Citiz
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Red Cross Hospital - Neurology
City
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okinawa Prefectural Nanbu Medical Center and Children's Medical Center
City
Shimajiri-Gun
ZIP/Postal Code
901-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center - PPDS
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byoung Joon Kim
Phone
82234102297
Email
sohyunsh.lee@samsung.com
First Name & Middle Initial & Last Name & Degree
Byoung Joon Kim
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Sung Park
Phone
821025181957
Email
neurojspark@gmail.com
First Name & Middle Initial & Last Name & Degree
Jin-Sung Park
Facility Name
Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-505
Country
Poland
Individual Site Status
Recruiting
Facility Name
NeuroProtect
City
Warsaw
State/Province
Mazovian
ZIP/Postal Code
01-684
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Recruiting
Facility Name
Gdanski Uniwersytet Medyczny
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Neuro-kard
City
Poznan
State/Province
Wielkopolska
ZIP/Postal Code
61-853
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia, Medic-R Spólka Komandytowa
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
61-731
Country
Poland
Individual Site Status
Recruiting
Facility Name
University Clinical Center of Serbia - PPDS
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stojan Peric
Email
stojanperic@gmail.com
Facility Name
University Clinical Centre Nis
City
Nis
ZIP/Postal Code
700461
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gordana Djordjevic
Phone
3811841584
Email
gordanadjor@gmail.com
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Cortes Vicente
Phone
34935537115
Email
mvidalf@santpau.cat
First Name & Middle Initial & Last Name & Degree
Elena Cortes Vicente
Facility Name
Hospital Universitario La Paz - PPDS
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Javier Rodriguez de Rivera
Phone
34917277444
Email
frriveragarrido@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Francisco Javier Rodriguez de Rivera
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nai-Wen Tsai
Phone
886929106337
Email
sandy.liu1022@gmail.com
First Name & Middle Initial & Last Name & Degree
Nai-Wen Tsai
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuh-Cherng Guo
Phone
886912364490
Email
eddysue0703@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yuh-Cherng Guo
Facility Name
National Cheng Kung University Hospital
City
Tainan City
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Ting Sun
Phone
88662353535
Ext
3978
Email
lyctw2016@gmail.com
First Name & Middle Initial & Last Name & Degree
Yuan Ting Sun
Facility Name
Shin Kong Wu Ho Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiann-Horng Yeh
Phone
886984160500
Email
m001074@ms.skh.org.tw
First Name & Middle Initial & Last Name & Degree
Jiann-Horng Yeh
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Long-Sun Ro
Phone
886963676066
Email
cgrols333@gmail.com
First Name & Middle Initial & Last Name & Degree
Long-Sun Ro
Facility Name
Dokuz Eylul University Medical Faculty
City
Balcova
State/Province
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli University Hospital
City
Umuttepe
State/Province
Van
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hüsnü EFENDİ
Phone
0(532) 573 70 21
Email
husnuefendi@gmail.com
Facility Name
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
City
Samsun
ZIP/Postal Code
55239
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murat Terzi
Phone
905323156884
Email
mterzi@omu.edu.tr
First Name & Middle Initial & Last Name & Degree
Murat Terzi
Facility Name
Karadeniz Technical University Farabi Hospital
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Sheffield Teaching Hospital NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
511 9NE
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Channa Hewamadduma
Phone
01142711900
Email
c.hewamadduma@nhs.net
Facility Name
University Hospital Birmingham
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing Time Frame
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD Sharing Access Criteria
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD Sharing URL
https://vivli.org/

Learn more about this trial

A Study to Examine the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients With Symptomatic Generalized Myasthenia Gravis

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