Clinical trial NCT03963232: A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Galcanezumab in Patients With Episodic Migraine-the Persist Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Episodic Migraine
Keywords: prevention
prophylactic
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-05-24
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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or another calcitonin gene-related peptide (CGRP) antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody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

Primary outcomes:
measure: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
timeFrame: Baseline, 3 Months
Secondary outcomes:
measure: 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.
timeFrame: 3 Months
measure: 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.
timeFrame: Baseline, 3 Months
measure: 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.
timeFrame: Baseline, 3 Months
measure: Overall Mean Change From Baseline in the Number of Monthly Headache Days During the Double-blind Treatment Phase.
timeFrame: Baseline, 3 Months
measure: Percentage of Participants Who Maintain 50% Response Criteria During the Double-blind Treatment Phase.
timeFrame: Month 1 to Month 3
measure: Overall Mean Change From Baseline in Number of Monthly Migraine Attacks During the Double-blind Treatment Phase.
timeFrame: Baseline, 3 Months
measure: Overall Mean Change From Baseline in Number of Monthly Migraine Headache Hours During the Double-blind Treatment Phase.
timeFrame: Baseline, 3 Months
measure: Overall Mean Change From Baseline in Number of Monthly Headache Hours During the Double-blind Treatment Phase.
timeFrame: Baseline, 3 Months
measure: Overall Mean Change From Baseline in Severity of Migraine Headaches During the Double-blind Treatment Phase.
timeFrame: Baseline, 3 Months
measure: Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score at Month 3 During the Double-blind Treatment Phase.
timeFrame: Baseline, Month 3
measure: Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 During the Double-blind Treatment Phase.
timeFrame: Baseline, Month 3
measure: Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) During the Double-blind Treatment Phase.
timeFrame: Baseline to Month 3
measure: Pharmacokinetics (PK): Serum Concentration of Galcanezumab During the Double-blind Treatment Phase.
timeFrame: Month 3
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital-Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guiyang
country: China
facility: The Affiliated Hospital of Guiyang Medical College
state: Guizhou
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou Universtiy
state: Henan
city: Wu Han
country: China
facility: Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Suzhou
country: China
facility: The First Affliated Hospital of Soochow University
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Changchun City
country: China
facility: No.2 Hospital Affiliated to Jilin University
state: Jilin
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Jinnan District
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Nanjing
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Rizhao
country: China
facility: People's hospital of Rizhao
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: HuaShan Hospital Affiliated To Fudan University
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Baotou
country: China
facility: Bao Tou Central Hospital
state: Zizhiqu
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Apollo Hospitals International Ltd.
state: Gujarat
city: Gurgaon
country: India
facility: Artemis Hospital
state: Haryana
city: Mangalore
country: India
facility: Mangala Hospitals & Mangala Kidney Foundation
state: Karnataka
city: Indore
country: India
facility: CHL - Apollo Hospital
state: Madh Prad
city: Nagpur
country: India
facility: Getwell Hospital & Research Institute
state: Maharashtra
city: Nashik
country: India
facility: HCG Manavata Cancer Centre
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Maharashtra
city: New Delhi
country: India
facility: Gobind Ballabh Pant Hospital
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. Sechenov
city: Moscow
country: Russian Federation
facility: University Headache Clinic
city: Nizhny Novgorod
country: Russian Federation
facility: OOO "Medis"
city: St-Petersburg
country: Russian Federation
facility: Academician I.P. Pavlov First St-Petersburg State Medical University
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Hu 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.