A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine
PERSIST
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Galcanezumab in Patients With Episodic Migraine-the Persist Study
2 other identifiers
interventional
520
3 countries
40
Brief Summary
The reason for this study is to see if the drug galcanezumab is safe and effective in participants with episodic migraine. The study will last about 53 weeks and may include up to 12 visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2019
Typical duration for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 24, 2019
CompletedStudy Start
First participant enrolled
July 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2022
CompletedResults Posted
Study results publicly available
August 19, 2022
CompletedMarch 28, 2023
March 1, 2023
2 years
May 16, 2019
June 29, 2022
March 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
MHD is a calendar day on which a migraine or probable migraine (a headache missing 1 of the migraine features) occurred. Per International Headache Society \[IHS\] International Classification of Headache Disorders 3rd edition \[ICHD-3\], migraine is defined as a headache, with or without aura, of ≥30 minutes duration with the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Overall mean is derived from the average of months 1 to 3 with Least square (LS) mean change calculated using mixed model repeat measures (MMRM) model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Baseline, 3 Months
Secondary Outcomes (13)
Overall Mean Percentage of Participants With ≥30%, ≥50%, ≥75%, 100% Reduction From Baseline in Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
3 Months
Overall Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality-of-Life Questionnaire Version 2.1 (MSQ v2.1) During the Double-blind Treatment Phase.
Baseline, 3 Months
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Headache During the Double-blind Treatment Phase.
Baseline, 3 Months
Overall Mean Change From Baseline in the Number of Monthly Headache Days During the Double-blind Treatment Phase.
Baseline, 3 Months
Percentage of Participants Who Maintain 50% Response Criteria During the Double-blind Treatment Phase.
Month 1 to Month 3
- +8 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATOR* Double-blind treatment phase: Participants received placebo once per month subcutaneously (SC) for 3 months. * Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they received 240 milligram (mg) loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months. * Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
Galcanezumab 120 mg
EXPERIMENTAL* Double-blind treatment phase: Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months. * Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months. * Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
Interventions
Eligibility Criteria
You may qualify if:
- Participants must have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 (1.1 or 1.2) (ICHD-3 2018) with a history of migraine of at least 1 year prior to screening and migraine onset prior to age 50
- Prior to screening, participants must have a history of 4-14 migraine headache days and at least 2 migraine attacks per month on average within the past 3 months
You may not qualify if:
- Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody
- Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (for example, adalimumab, infliximab, trastuzumab, bevacizumab, etc.)
- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab
- Women who are pregnant or nursing
- History of chronic migraine, daily persistent headache, cluster headache, medication overuse headache, migraine with brainstem aura, or hemiplegic migraine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Xuanwu Hospital-Capital Medical University
Beijing, Beijing Municipality, 100053, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
The First Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
The Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou, 550004, China
The First Affiliated Hospital of Zhengzhou Universtiy
Zhengzhou, Henan, 450052, China
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
Wuhan, Hubei, 430030, China
Xiangya Hospital, Central South University
Changsha, Hunan, 410008, China
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000, China
No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, 130041, China
Tianjin Huanhu Hospital
Tianjin, Jinnan District, 300350, China
Jiangsu Province Hospital
Nanjing, Nanjing, 210029, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
People's hospital of Rizhao
Rizhao, Shandong, 276826, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 20000, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
HuaShan Hospital Affiliated To Fudan University
Shanghai, Shanghai Municipality, 20040, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Zhejiang Hospital
Hangzhou, Zhejiang, 310013, China
Bao Tou Central Hospital
Baotou, Zizhiqu, 014040, China
Apollo Hospitals International Ltd.
Ahmedabad, Gujarat, 382428, India
Artemis Hospital
Gurgaon, Haryana, 122001, India
Mangala Hospitals & Mangala Kidney Foundation
Mangalore, Karnataka, 575003, India
CHL - Apollo Hospital
Indore, Madh Prad, 452008, India
Getwell Hospital & Research Institute
Nagpur, Maharashtra, 440012, India
HCG Manavata Cancer Centre
Nashik, Maharashtra, 422001, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
Gobind Ballabh Pant Hospital
New Delhi, 110002, India
First Moscow State Medical University n.a. Sechenov
Moscow, 119991, Russia
University Headache Clinic
Moscow, 121467, Russia
OOO "Medis"
Nizhny Novgorod, 603137, Russia
Academician I.P. Pavlov First St-Petersburg State Medical University
Saint Petersburg, 197022, Russia
Related Publications (2)
Zhou J, Zhong L, Chowdhury D, Skorobogatykh K, Luo G, Yang X, Zhang M, Sun L, Liu H, Qian C, Yu S. Galcanezumab in patients with episodic migraine: results from the open-label period of the phase 3 PERSIST study. J Headache Pain. 2023 Aug 4;24(1):103. doi: 10.1186/s10194-023-01613-1.
PMID: 37542222DERIVEDHu B, Li G, Li X, Wu S, Yu T, Li X, Zhao H, Jia Z, Zhuang J, Yu S. Galcanezumab in episodic migraine: the phase 3, randomized, double-blind, placebo-controlled PERSIST study. J Headache Pain. 2022 Jul 28;23(1):90. doi: 10.1186/s10194-022-01458-0.
PMID: 35896988DERIVED
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2019
First Posted
May 24, 2019
Study Start
July 30, 2019
Primary Completion
July 27, 2021
Study Completion
March 11, 2022
Last Updated
March 28, 2023
Results First Posted
August 19, 2022
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.