Back to resultsA Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine (REBUILD-2)
Primary Purpose
Chronic Migraine
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Galcanezumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Migraine focused on measuring pediatric, children, prevention, prophylaxis, headache, pediatric migraine
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3 according to ICHD-3 [2018]), that is, a headache occurring on 15 or more days per month for at least the last 3 months, which has the features of migraine headache on at least 8 days per month.
Exclusion Criteria:
- Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.). Prior use of therapeutic antibodies is allowed if that use was more than 12 months prior to baseline, except for antibodies to CGRP or its receptor, which are not allowed at any time prior to study entry.
- Known hypersensitivity monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
- Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody. Participant must also not have prior oral CGRP antagonist use within 30 days prior to baseline.
- History of IHS ICHD-3 diagnosis of new daily persistent headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine).
- History of significant head or neck injury within 6 months prior to screening; or traumatic head injury at any time that is associated with significant change in the quality or frequency of their headaches, including new onset of migraine following traumatic head injury.
- Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.
Sites / Locations
- Rehabilitation & Neurological ServicesRecruiting
- Xenoscience
- Velocity Clinical Research, ProvidenceRecruiting
- Velocity Clinical Research, ProvidenceRecruiting
- Miller Children's & Women's Hospital Long BeachRecruiting
- Wr-McCr, LlcRecruiting
- Children's Hospital ColoradoRecruiting
- Clinical Neuroscience Solutions, Inc. dba CNS HealthcareRecruiting
- Wellness Clinical ResearchRecruiting
- University of Miami Don Suffer Clinical Research BuildingRecruiting
- Ezy Medical ResearchRecruiting
- Private Practice - Dr. Laszlo J. MateRecruiting
- Sensible Healthcare, LLCRecruiting
- Avanza Medical Research CenterRecruiting
- USF HealthRecruiting
- ForCare Clinical ResearchRecruiting
- Rare Disease Research, LLC
- Medical Research PartnersRecruiting
- Northwest Clinical TrialsRecruiting
- Velocity Clinical Research, BoiseRecruiting
- St. Alexius Medical CenterRecruiting
- University of Kentucky Chandler Medical CenterRecruiting
- Pharmasite Research, Inc.Recruiting
- ActivMed Practices and ResearchRecruiting
- MedVadis Research CorporationRecruiting
- Minneapolis Clinic of Neurology - Burnsville OfficeRecruiting
- Children's Mercy HospitalRecruiting
- Dent Neurologic InstituteRecruiting
- Cohen Children's Northwell Health Physician Partners - Pediatric NeurologyRecruiting
- Velocity Clinical Research at Raleigh NeurologyRecruiting
- Providence Health & Services
- UPMC Children's Hospital of PittsburghRecruiting
- Velocity Clinical Research, ProvidenceRecruiting
- Coastal Pediatric ResearchRecruiting
- Pain and Headache Centers of TexasRecruiting
- Northwest Clinical Research CenterRecruiting
- Seattle Children's HospitalRecruiting
- Orange County Research Institute - OntarioRecruiting
- Sanos Clinic - NordjyllandRecruiting
- Herlev and Gentofte HospitalRecruiting
- Assistance Publique Hôpitaux de Marseille - Hôpital de la TimoneRecruiting
- Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger SalengroRecruiting
- Centre Hospitalier Universitaire EstaingRecruiting
- CHU d'Amiens-Picardie - Hôpital SudRecruiting
- Praxis Dr. Astrid Gendolla
- G.B. Pant Institute of Postgraduate Medical Education & ResearchRecruiting
- Sir Ganga Ram HospitalRecruiting
- Apollo Hospitals AhmedabadRecruiting
- Artemis hospitalRecruiting
- Mangala Hospital & Mangala Kidney FoundationRecruiting
- P.D. Hinduja Hospital and Medical Research CentreRecruiting
- Lillestol ResearchRecruiting
- All India Institute of Medical Sciences (AIIMS) - NagpurRecruiting
- Medipoint Hospitals Pvt. Ltd.
- Atmaram Child CareRecruiting
- Apollo Gleneagles Hospitals KolkataRecruiting
- Policlinico Umberto IRecruiting
- Ospedale Pediatrico Bambino Gesù
- Konan HospitalRecruiting
- Tokyo Medical University HospitalRecruiting
- Tanaka Neurosurgical ClinicRecruiting
- Umenotsuji ClinicRecruiting
- Tatsuoka Neurology ClinicRecruiting
- Tominaga HospitalRecruiting
- Tokyo Headache ClinicRecruiting
- Hospital Infantil de Mexico Federico GomezRecruiting
- PanAmerican Clinical Research - GuadalajaraRecruiting
- Clinica De Enfermedades Cronicas y Procedimientos EspecialesRecruiting
- Centro de Investigacion Medica AguascalientesRecruiting
- Unidad de Investigación en SaludRecruiting
- Isala, locatie ZwolleRecruiting
- Ponce Medical School Foundation Inc.Recruiting
- Barbara Diaz-Hernandez MD Research, Inc.Recruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Hospital Universitario La Paz-NEURORecruiting
- Hospital Universitario Virgen Del RocioRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Galcanezumab
Placebo
Arm Description
Galcanezumab administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.
Placebo administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.
Outcomes
Primary Outcome Measures
Change from Baseline in the Number of Monthly Migraine Headache Days
Change from Baseline in the Number of Monthly Migraine Headache Days
Secondary Outcome Measures
Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting
Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting
Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia
Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia
Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms
Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms
Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken
Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken
Patient Global Impression-Improvement (PGI-I) Rating
PGI-I Rating
Change from Baseline in the Severity of Remaining Migraine Headaches per Month
Change from Baseline in the Severity of Remaining Migraine Headaches per Month
Change from Baseline in the Number of Monthly Headache Days
Change from Baseline in the Number of Monthly Headache Days
Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score
Change from Baseline on the PedsQL Total Score
Change from Baseline on the Pediatric Migraine Disability Assessment test (PedMIDAS) Total Score
Change from Baseline on the PedMIDAS Total Score
Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the C-SSRS Score
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
PK: Serum Concentration of Galcanezumab
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Plasma Concentration of CGRP
Percentage of Participants Developing Anti-Drug Antibodies
Percentage of Participants Developing Anti-Drug Antibodies
Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase
Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase
Full Information
NCT ID
NCT04616326
First Posted
November 3, 2020
Last Updated
October 18, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT04616326
Brief Title
A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine
Acronym
REBUILD-2
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age With Chronic Migraine - the REBUILD-2 Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
March 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
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 main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
Detailed Description
The study includes a 3-month, randomized, double-blind treatment period in which participants receive either galcanezumab or placebo, followed by a 9-month open-label extension in which all participants receive galcanezumab. Enrollment in the European Union may also include participants 6 to 11 years of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
Keywords
pediatric, children, prevention, prophylaxis, headache, pediatric migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Galcanezumab
Arm Type
Experimental
Arm Description
Galcanezumab administered by SQ injection.
Participants may be eligible for optional open-label extension at the end of the double-blind period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered by SQ injection.
Participants may be eligible for optional open-label extension at the end of the double-blind period.
Intervention Type
Drug
Intervention Name(s)
Galcanezumab
Other Intervention Name(s)
LY2951742
Intervention Description
Administered SQ
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SQ
Primary Outcome Measure Information:
Title
Change from Baseline in the Number of Monthly Migraine Headache Days
Description
Change from Baseline in the Number of Monthly Migraine Headache Days
Time Frame
Baseline, 3 Months
Secondary Outcome Measure Information:
Title
Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Description
Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Time Frame
3 Months
Title
Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting
Description
Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting
Time Frame
Baseline, 3 Months
Title
Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia
Description
Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia
Time Frame
Baseline, 3 Months
Title
Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms
Description
Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms
Time Frame
Baseline, 3 Months
Title
Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken
Description
Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken
Time Frame
Baseline, 3 Months
Title
Patient Global Impression-Improvement (PGI-I) Rating
Description
PGI-I Rating
Time Frame
Month 1 to Month 3
Title
Change from Baseline in the Severity of Remaining Migraine Headaches per Month
Description
Change from Baseline in the Severity of Remaining Migraine Headaches per Month
Time Frame
Baseline, 3 Months
Title
Change from Baseline in the Number of Monthly Headache Days
Description
Change from Baseline in the Number of Monthly Headache Days
Time Frame
Baseline, 3 Months
Title
Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score
Description
Change from Baseline on the PedsQL Total Score
Time Frame
Baseline, 3 Months
Title
Change from Baseline on the Pediatric Migraine Disability Assessment test (PedMIDAS) Total Score
Description
Change from Baseline on the PedMIDAS Total Score
Time Frame
Baseline, 3 Months
Title
Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Description
Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the C-SSRS Score
Time Frame
Baseline through 3 Months
Title
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Description
PK: Serum Concentration of Galcanezumab
Time Frame
Baseline through 3 Months
Title
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Description
Plasma Concentration of CGRP
Time Frame
Baseline through 3 Months
Title
Percentage of Participants Developing Anti-Drug Antibodies
Description
Percentage of Participants Developing Anti-Drug Antibodies
Time Frame
Baseline through 3 Months
Title
Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase
Description
Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase
Time Frame
16 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3 according to ICHD-3 [2018]), that is, a headache occurring on 15 or more days per month for at least the last 3 months, which has the features of migraine headache on at least 8 days per month.
Exclusion Criteria:
Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.). Prior use of therapeutic antibodies is allowed if that use was more than 12 months prior to baseline, except for antibodies to CGRP or its receptor, which are not allowed at any time prior to study entry.
Known hypersensitivity monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody. Participant must also not have prior oral CGRP antagonist use within 30 days prior to baseline.
History of IHS ICHD-3 diagnosis of new daily persistent headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine).
History of significant head or neck injury within 6 months prior to screening; or traumatic head injury at any time that is associated with significant change in the quality or frequency of their headaches, including new onset of migraine following traumatic head injury.
Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Rehabilitation & Neurological Services
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belinda Savage-Edwards, MD
Facility Name
Xenoscience
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Completed
Facility Name
Velocity Clinical Research, Providence
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinesh Talwar
Facility Name
Velocity Clinical Research, Providence
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Duarte
Facility Name
Miller Children's & Women's Hospital Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmin Dao
Facility Name
Wr-McCr, Llc
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Simmons
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcy Yonker
Facility Name
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nandita Jones
Facility Name
Wellness Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucky Flores
Facility Name
University of Miami Don Suffer Clinical Research Building
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Horn
Facility Name
Ezy Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Paoli-Bruno
Facility Name
Private Practice - Dr. Laszlo J. Mate
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laszlo Mate
Facility Name
Sensible Healthcare, LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Nanette Taylor
Facility Name
Avanza Medical Research Center
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randall E Reese
Facility Name
USF Health
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
Kavita Kalidas
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seth Benjamin Forman
Facility Name
Rare Disease Research, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Phan
Facility Name
Medical Research Partners
City
Ammon
State/Province
Idaho
ZIP/Postal Code
83406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Reed Moore
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brock Aaron McConnehey
Facility Name
Velocity Clinical Research, Boise
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Alan Turner
Facility Name
St. Alexius Medical Center
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdul Mazin
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharoon Qaiser
Facility Name
Pharmasite Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Herts
Facility Name
ActivMed Practices and Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Shoeck
Facility Name
MedVadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David DiBenedetto
Facility Name
Minneapolis Clinic of Neurology - Burnsville Office
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajiv Aggarwal
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina Jones
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer McVige
Facility Name
Cohen Children's Northwell Health Physician Partners - Pediatric Neurology
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Pavkovic
Facility Name
Velocity Clinical Research at Raleigh Neurology
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Boyce
Facility Name
Providence Health & Services
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Christy
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
412-692-5055
First Name & Middle Initial & Last Name & Degree
Catalina Cleves-Bayon
Facility Name
Velocity Clinical Research, Providence
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David L. Fried
Facility Name
Coastal Pediatric Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Kummer Lehman
Facility Name
Pain and Headache Centers of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Ummat
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arifulla Khan, MD
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Blume
Facility Name
Orange County Research Institute - Ontario
City
Ontario
ZIP/Postal Code
91762
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosario Retino
Facility Name
Sanos Clinic - Nordjylland
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9362
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helene Rovsing
Facility Name
Herlev and Gentofte Hospital
City
Denmark
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
Phone
4538685131
First Name & Middle Initial & Last Name & Degree
Nanette Mol Debes
Facility Name
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Donnet
Facility Name
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
City
Lille
State/Province
Nord-Pas-de-Calais
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine AVEZ COUTURIER
Facility Name
Centre Hospitalier Universitaire Estaing
City
Clermont-Ferrand
State/Province
Puy-de-Dôme
ZIP/Postal Code
63100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine SARRET
Facility Name
CHU d'Amiens-Picardie - Hôpital Sud
City
Amiens
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Berquin
Facility Name
Praxis Dr. Astrid Gendolla
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45133
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
G.B. Pant Institute of Postgraduate Medical Education & Research
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debashish Chowdhury
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohtagi Anshu
Facility Name
Apollo Hospitals Ahmedabad
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
382428
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sucheta Mudgerikar
Facility Name
Artemis hospital
City
Gurugram
State/Province
Haryana
ZIP/Postal Code
122003
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumit Singh
Facility Name
Mangala Hospital & Mangala Kidney Foundation
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575003
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shankara Nellikunja
Facility Name
P.D. Hinduja Hospital and Medical Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400016
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
vrajesh prabhakar udani
Facility Name
Lillestol Research
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prafulla Keshaorao Shembalkar
Facility Name
All India Institute of Medical Sciences (AIIMS) - Nagpur
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
441108
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meenakshi Girish
Facility Name
Medipoint Hospitals Pvt. Ltd.
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411007
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pramod Jog
Facility Name
Atmaram Child Care
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208011
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinay Bajpai
Facility Name
Apollo Gleneagles Hospitals Kolkata
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ARIJIT CHATTOPADHYAY
Facility Name
Policlinico Umberto I
City
Roma
State/Province
Lazio
ZIP/Postal Code
161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
paola verdecchia
Facility Name
Ospedale Pediatrico Bambino Gesù
City
Roma
ZIP/Postal Code
165
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimiliano Valeriani
Facility Name
Konan Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
658-0064
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigekazu Kitamura
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaku Yamanaka
Facility Name
Tanaka Neurosurgical Clinic
City
Kagoshima
ZIP/Postal Code
892-0844
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeya Tanaka
Facility Name
Umenotsuji Clinic
City
Kochi
ZIP/Postal Code
780-8011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Yamada
Facility Name
Tatsuoka Neurology Clinic
City
Kyoto
ZIP/Postal Code
600-8811
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshihisa Tatsuoka
Facility Name
Tominaga Hospital
City
Osaka
ZIP/Postal Code
556-0017
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81120023812
First Name & Middle Initial & Last Name & Degree
Takao Takeshima
Facility Name
Tokyo Headache Clinic
City
Tokyo
ZIP/Postal Code
151-0051
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazutaka Shimizu
Facility Name
Hospital Infantil de Mexico Federico Gomez
City
Ciudad de Mexico
State/Province
Federal District
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Garcia Beristain
Facility Name
PanAmerican Clinical Research - Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ixiu del Carmen Cabrales Guerra
Facility Name
Clinica De Enfermedades Cronicas y Procedimientos Especiales
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58249
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
524433232828
First Name & Middle Initial & Last Name & Degree
Carlos Toledo
Facility Name
Centro de Investigacion Medica Aguascalientes
City
Aguascalientes
ZIP/Postal Code
20116
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarug Reyes Morales
Facility Name
Unidad de Investigación en Salud
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avril Molina Garcia
Facility Name
Isala, locatie Zwolle
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025 AB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jolita Bekhof
Facility Name
Ponce Medical School Foundation Inc.
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odette Olivieri Ramos
Facility Name
Barbara Diaz-Hernandez MD Research, Inc.
City
San Juan
ZIP/Postal Code
926
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ileana M Fumero-Perez
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
8041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Belvis Nieto
Facility Name
Hospital Universitario La Paz-NEURO
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34917277444
First Name & Middle Initial & Last Name & Degree
Manuel Lara Lara
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
carmen Gonzalez oria
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/1mozTDMc0KoyNzh7Twsl5c
Description
A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine (REBUILD-2)
Learn more about this trial
A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine
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