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Episodic MigrainePhase 3PERSISTNCT03963232

A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine

A Phase 3 study testing Galcanezumab in people with Episodic Migraine, run by Eli Lilly and Company at 40 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Episodic Migraine
What is being tested?
Galcanezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
520 participants
Where
40 sitesin 3 countries
Study dates
30 Jul 2019to 11 Mar 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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or another calcitonin gene-related peptide (CGRP) antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody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

Trial locations and contacts

40 sites in 3 countries.

40 sites in 3 countries

China26 sites

  • Bao Tou Central Hospital

    Baotou, Zizhiqu, 014040

  • Xuanwu Hospital-Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • No.2 Hospital Affiliated to Jilin University

    Changchun, Jilin, 130041

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • The Affiliated Hospital of Guiyang Medical College

    Guiyang, Guizhou, 550004

  • Zhejiang Hospital

    Hangzhou, Zhejiang, 310013

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Jiangsu Province Hospital

    Nanjing, Nanjing, 210029

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337000

  • People's hospital of Rizhao

    Rizhao, Shandong, 276826

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 20000

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • HuaShan Hospital Affiliated To Fudan University

    Shanghai, Shanghai Municipality, 20040

  • The First Affliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

  • Tianjin Huanhu Hospital

    Tianjin, Jinnan District, 300350

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

  • Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

    Wuhan, Hubei, 430030

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • The First Affiliated Hospital of Zhengzhou Universtiy

    Zhengzhou, Henan, 450052

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212000

Other trials in China

India10 sites

  • Apollo Hospitals International Ltd.

    Ahmedabad, Gujarat, 382428

  • Artemis Hospital

    Gurgaon, Haryana, 122001

  • CHL - Apollo Hospital

    Indore, Madh Prad, 452008

  • Mangala Hospitals & Mangala Kidney Foundation

    Mangalore, Karnataka, 575003

  • Getwell Hospital & Research Institute

    Nagpur, Maharashtra, 440012

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra, 422001

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

  • Gobind Ballabh Pant Hospital

    New Delhi, 110002

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411004

Other trials in India

Russia4 sites

  • First Moscow State Medical University n.a. Sechenov

    Moscow, 119991

  • University Headache Clinic

    Moscow, 121467

  • OOO "Medis"

    Nizhny Novgorod, 603137

  • Academician I.P. Pavlov First St-Petersburg State Medical University

    Saint Petersburg, 197022

Other trials in Russia

About this study

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

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.

Being tested
Galcanezumab, Placebo
Keywords
prevention, prophylactic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalcanezumabDrug

    Also called LY2951742

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT03963232
Study groupRoleWhat they receive
PlaceboPlacebo 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.
Receives: Drug: Placebo
Galcanezumab 120 mgExperimental* 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.
Receives: Drug: Galcanezumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 3 Months

Secondary outcomes (13)

  1. 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.

    Participant having:

    • 30% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 30% response rate to treatment or "30% responder."
    • 50% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 50% response rate to treatment or "50% responder."
    • 75% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 75% response rate to treatment or "75% responder."
    • 100% reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 100% response rate to treatment or "100% responder." Overall mean is derived from the average of months 1 to 3 using generalized linear mixed model (GLIMMIX) with the fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariate of baseline value.

    Measured: 3 Months

  2. 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.

    MSQ v2.1 is a self-administered instrument that was developed to address physical, emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 3 domains: Role Function-Restrictive (items 1-7), Role Function- Preventive (items 8-11) and Emotional Function (items 12-14). All item responses ranges from 1 (none of the time) to 6 (all of the time). Total raw scores for each domain is the sum of the raw scores of each item in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using 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.

    Measured: Baseline, 3 Months

  3. 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.

    Number of monthly migraine headache days requiring medication for the acute treatment of headache is defined as the number of calendar days in a 30-day period on which migraine or probable migraine occurs and acute medication is used. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using 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.

    Measured: Baseline, 3 Months

  4. Overall Mean Change From Baseline in the Number of Monthly Headache Days During the Double-blind Treatment Phase.

    Number of monthly headache days is the number of calendar days in a 30-day period on which a headache occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using 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.

    Measured: Baseline, 3 Months

  5. Percentage of Participants Who Maintain 50% Response Criteria During the Double-blind Treatment Phase.

    Percentage of participants who maintained 50% response rate to treatment in all 3 months of the double-blind treatment phase.

    Measured: Month 1 to Month 3

  6. Overall Mean Change From Baseline in Number of Monthly Migraine Attacks During the Double-blind Treatment Phase.

    Number of monthly migraine attacks is the number of sets of consecutive days with migraine or probable migraine separated by at least one migraine-free day in a 30-day period day. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using 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.

    Measured: Baseline, 3 Months

  7. Overall Mean Change From Baseline in Number of Monthly Migraine Headache Hours During the Double-blind Treatment Phase.

    Number of monthly migraine headache hours is the total number of headache hours in a 30-day period on days when a migraine or probable migraine occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using 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.

    Measured: Baseline, 3 Months

  8. Overall Mean Change From Baseline in Number of Monthly Headache Hours During the Double-blind Treatment Phase.

    Number of monthly headache hours is the total number of headache hours in a 30-day period on which a headache occurred. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using 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.

    Measured: Baseline, 3 Months

  9. Overall Mean Change From Baseline in Severity of Migraine Headaches During the Double-blind Treatment Phase.

    Severity of Migraine Headache was measured on a headache severity scale ranging from 1 to 3 with 1=mild, 2=moderate, and 3=severe. The mean severity of migraine headache for each month will be calculated as: sum of severity of migraine headache days divided by number of migraine headache days. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using 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.

    Measured: Baseline, 3 Months

  10. Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score at Month 3 During the Double-blind Treatment Phase.

    PGI-S is a 7-point scale that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options range from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean change was calculated using analysis of variance (ANCOVA) model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.

    Measured: Baseline, Month 3

  11. Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 During the Double-blind Treatment Phase.

    The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on migraineurs' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability. LS mean change was calculated using ANCOVA model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.

    Measured: Baseline, Month 3

  12. Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) During the Double-blind Treatment Phase.

    A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer >= 20.

    Measured: Baseline to Month 3

  13. Pharmacokinetics (PK): Serum Concentration of Galcanezumab During the Double-blind Treatment Phase.

    PK: Serum concentration of galcanezumab

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2019
  2. Study start30 Jul 2019
  3. Primary completion27 Jul 2021
  4. Study completion11 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03963232
Sponsor's protocol ID
17054
Other IDs
I5Q-MC-CGAX
Acronym
PERSIST
Status last verified
Mar 2023
First submitted
16 May 2019
Last updated
28 Mar 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37542222

  • 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.

    PubMed 35896988

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Galcanezumab in people with Episodic Migraine, run by Eli Lilly and Company at 40 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China, India, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase. (time frame: Baseline, 3 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03963232, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.

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