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CTRI Number  CTRI/2026/01/101202 [Registered on: 15/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   This study is to evaluate Migraine(Severe Headache) from 6 years to 17 Years of age. 
Scientific Title of Study   A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age with Episodic Migraine – the REBUILD-1 Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
I5Q-MC-CGAS version (i) dated 04-Aug-2023   DCGI 
NCT03432286  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manish Mistry  
Designation  Medical Director 
Affiliation  Eli Lilly and Company(India) pvt.Ltd 
Address  Plot No-92,Sec-32,Institutional Area,Gurgaon-122001 India

Gurgaon
HARYANA
122001
India 
Phone  9820234897  
Fax    
Email  manish.mistry@lilly.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Mistry  
Designation  Medical Director 
Affiliation  Eli Lilly and Company(India) pvt.Ltd 
Address  Plot No-92,Sec-32,Institutional Area,Gurgaon-122001 India

Gurgaon
HARYANA
122001
India 
Phone  9820234897  
Fax    
Email  manish.mistry@lilly.com   
 
Details of Contact Person
Public Query  
Name  Dr Rajeev Sharan Shrivastava 
Designation  Associate Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd.  
Address  Plot No-92,Sec-32,Institutional Area,Gurgaon-122001 India

Gurgaon
HARYANA
122001
India 
Phone  9810308697  
Fax    
Email  shrivastava_rajeev_sharan@lilly.com   
 
Source of Monetary or Material Support  
Eli Lilly and Company (India) Pvt Ltd, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001 
 
Primary Sponsor  
Name  Eli Lilly and Company India Pvt Ltd  
Address  Plot No. 92, Sector-32, Gurgaon, Haryana - 122001  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Pharmaceutical Research Associates India Private Limited  Level 3 & 4, Prestige Blue Chip Software Park, Municipal No. 9, Hosur Road, Adugodi, Madiwala Range, Ward No. 63, Bangalore, Tavarekere, Bangalore South, Bangalore- 560029, Karnataka, India  
 
Countries of Recruitment     Denmark
Germany
India
Italy
Japan
Mexico
Netherlands
Spain
United States of America  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Meenakshi Girish   All India Institute of Medical Sciences   Plot no. 2, Sector 20, Sumthana, MIHAN, Nagpur, 441108 Maharashtra Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA 		 91-9823084604

meenakshimgirish@gmail.com  
Dr Amarjeet Wagh   Central India Cardiology and Research Institute  Gawande Layout, Khamla Ring Road, Opp Sawarkar Garden, Plot No 1, Pioneer Co-Op Operating Society, Khamla, Nagpur, Maharashtra, India, 440015 Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA 		 7776871744

amarjeet.wagh2001@gmail.com  
Dr Nellikunja Shankara   Mangala Hospitals & Mangala Kidney Foundation   VAJRA HILS, KADRI ROAD, Mangalore 575003 Karnataka India Bangalore KARNATAKA
Bangalore
KARNATAKA 		 8242443088

dr.shankara.mnc@gmail.com  
Dr Pramod Jog  Medipoint Hospitals Private Limited   241/1 New D.P. Road, Aundh, Pune, Maharashtra, India, 411007 Pune MAHARASHTRA
Pune
MAHARASHTRA 		 91-9422309677

drpramod.medipoint@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee for Clinical Trial, All India Institute of Medical Sciences   Approved 
Institutional Ethics Committee, Rughwani Child Care Centre & Hospital  Approved 
Mangala Institutional Ethics Committee   Approved 
Penta-Med Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G431||Migraine with aura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Galcanezumab  The main 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. 
Comparator Agent  Placebo  The study addendum is a stand-alone study of galcanezumab pharmacokinetics and safety in a group of participants separate from those in the main study. The study addendum includes a 5-month evaluation period after a single injection of galcanezumab, followed by a 9-month open-label extension. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Have a diagnosis of migraine with or without aura as defined by the IHS ICHD-3 guidelines (1.1 or 1.2 according to ICHD-3 [2018]), with a history of migraine headaches of at least the last 6 months prior to screening. 
 
ExclusionCriteria 
Details  1. 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, other than antibodies to calcitonin gene-related peptide (CGRP) or its receptor, is allowed if that use was more than 12 months prior to baseline.
2. Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
3. 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.
4. History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine) as defined by IHS ICHD-3.
5. 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.
6. Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Change from Baseline in the Number of Monthly Migraine Headache Days   Baseline, 3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of Participants with Reduction from Baseline greater than or equal to 50%, greater than or equal to 75% and 100% in Monthly Migraine Headache Days   3 months  
1. Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting
2. Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia
3. Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms
4. Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken
 		 Baseline, 3 Months  
Patient Global Impression-Improvement (PGI-I) Rating   Month 1 to Month 3  
1. Change from Baseline in the Severity of Remaining Migraine Headaches per Month
2. Change from Baseline in the Number of Monthly Headache Days
3. Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score
4. Change from Baseline on the Pediatric Migraine Disability Assessment test (PedMIDAS) Total Score
 		 Baseline, 3 Months  
1. Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score
2. Pharmacokinetics (PK): Serum Concentration of Galcanezumab
3. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
4. Percentage of Participants Developing Anti-Drug Antibodies
 		 Baseline through 3 Months  
Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase   16 months  
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   09/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/03/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="10"
Days="2" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  -www.vivli.org

  6. For how long will this data be available start date provided 28-10-2021 and end date provided 27-04-2022?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The main purpose of this study is to evaluate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. 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.  
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