MigrainePhase 2NCT02959177
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine
A Phase 2 study testing Galcanezumab in people with Migraine, run by Eli Lilly and Company at 47 sites in Japan.
Trial summary
The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in Japanese participants with episodic migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- 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
- 459 participants
- Where
- 47 sitesJapan
- Study dates
- 9 Nov 2016to 18 Jan 2019
- Phase
- Phase 2
- 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
- Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
Who cannot join
- Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
- Current use or prior exposure to Galcanezumab or other antibodies to CGRP or its receptor.
- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
- History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
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Chiba, 275-0026
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Chofu-shi, 182-0006
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Fukui, 918 8503
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Fukui, 9188503
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Fukuoka, 816 0824
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Higashioka, 578-8588
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Hiroshima, 730-0031
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Iruma-Gun, 350-0495
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Kagoshima, 892-0842
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Kasaoka-shi, 714-0043
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Kawasaki, 211-8588
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Kawasaki, 2118588
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Kobe, 658-0064
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Kobe, 6580064
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Kochi, 780-8011
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Kōchi, 780-0051
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Kyoto, 600-8811
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Kyoto, 606-0851
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Matsuyama, 790-0925
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Matsuyama, 790-0925
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Minatoku, 108-8642
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Minatoku, 1088642
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Morioka, 020-0034
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Morioka, 020-8505
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Morioka, 0200034
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Niigata, 9493193
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Nishinomiya, 663-8014
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Nishinomiya, 663-8204
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Nishinomiya, 663-8204
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Ōita, 870-0831
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Okayama, 700-8557
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Osaka, 556-0015
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Ota-shi, 373-8585
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Saijo-shi, 793-0030
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Saitama, 338 8577
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Sapporo, 003-0003
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Sapporo, 060-8570
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Sendai, 982-0014
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Shibuya-ku, 151-0051
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Shinjuku-ku, 160-0017
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Shizuoka, 420-0853
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Tachikawa-shi, 190-8531
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Tokyo, 160-8582
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Tōyama, 9300803
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Yamaguchi, 754-0002
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Yamanashi, 400-0124
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Yamanashi, 4000124
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 (Galcanezumab) in Japanese Patients With Episodic Migraine
The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in Japanese participants with episodic migraine.
- Conditions
- Migraine
- Being tested
- Galcanezumab, Placebo
- Keywords
- prevention, prophylaxis, headache
- Medical subject headings
- Migraine Disorders, Headache
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 group | Role | What they receive |
|---|---|---|
| 120 milligrams (mg) Galcanezumab | Experimental | 120 mg galcanezumab (LY2951742) administered subcutaneously (SC) once a month for 6 months. Receives: Drug: Galcanezumab |
| 240 mg Galcanezumab | Experimental | 120 mg galcanezumab (LY2951742) administered SC once a month for 6 months. Receives: Drug: Galcanezumab |
| Placebo | Placebo comparator | Placebo administered SC once a month for 6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.
Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B):
- 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; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; The overall mean is derived from the average of months 1 to 6 from mixed model repeat measures (MMRM) model. Least Square Mean (LSMEAN) was calculated using MMRM models with fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariates of baseline value and baseline-by-month interaction.
Measured: Baseline, Month 1 through Month 6
Secondary outcomes (14)
Percentage of Participants With a 50% or Greater Reduction From Baseline in Monthly Migraine Headache Days
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 50% responder in a particular month is any participant who has a ≥50% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval. It is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, and baseline MHD category as fixed factors.
Measured: Baseline, Month 1 through Month 6
Percentage of Participants With a 75% or Greater Reduction From Baseline in Monthly Migraine Headache Days
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 75% responder in a particular month is any participant who has a ≥75% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval. It is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, and baseline MHD category as fixed factors.
Measured: Baseline, Month 1 through Month 6
Percentage of Participants With a 100% Reduction From Baseline in Monthly Migraine Headache Days
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 100% responder in a particular month is any participant who has a 100% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval. It is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, and baseline MHD category as fixed factors.
Measured: Baseline, Month 1 through Month 6
Overall Mean Change From Baseline on the Migraine-Specific Quality (MSQ) of Life Questionnaire
MSQ version 2.1 is a health status instrument consists of 14 items addressing 3 domains:(1)Role Function-Restrictive (items 1-7);(2)Role Function- Preventive (items 8-11);\&(3)Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), \& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After total raw score is computed for each domain \& total score, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement. The overall mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, month, treatment by month, baseline by month and baseline MHD category as fixed factors.
Measured: Baseline, Month 4 through Month 6
Overall Mean Change From Baseline in Number of Migraine Headache Days With Acute Medication Use
Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication.
The overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.
Measured: Baseline, Month 1 through Month 6
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). Mean is derived from the average of months 4 to 6 from MMRM model. Least square mean (LSM) was calculated using an MMRM model with treatment, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.
Measured: Baseline, Month 4 through Month 6
Overall Mean Change From Baseline in Headache Hours
Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using the MMRM model with treatment, month, treatment by month, baseline, baseline by month and baseline MHD category.
Measured: Baseline, Month 1 through Month 6
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability.
LSMean was calculated using MMRM model with treatment, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.
Measured: Baseline, Month 6
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects. Satisfaction responses range from "very unsatisfied" to "very satisfied" with the current treatment. Preference compares the current study medication to previous medications, with responses from "much rather prefer my previous medication" to "much rather prefer the medication administered to me during the study"
Measured: Month 6
Number of Participants With Suicidal Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thoughts occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation (SI): a "yes" answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent
Measured: Month 1 through Month 6
Number of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
C -SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.
Measured: Month 1 through Month 6
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab
Treatment emergent ADA will be defined as any of the following:
- A negative baseline result and a positive post-baseline ADA result with a titer ≥20. This is also called treatment-induced ADA.
- A positive baseline result and a positive post-baseline ADA result with a ≥4-fold increase in titers (for example, baseline titer of 10 increasing to ≥40 post-baseline). This is called treatment-boosted ADA.
Measured: Baseline through Month 6
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Measured: Month 6
Total Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Total Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start9 Nov 2016
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959177
- Sponsor's protocol ID
- 15796
- Other IDs
- I5Q-JE-CGAN
- Status last verified
- Feb 2019
- First submitted
- 7 Nov 2016
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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
Takeshima T, Doi H, Ooba S, Tanji Y, Ozeki A, Komori M. Clinical Evaluation After Discontinuation of Galcanezumab in Japanese Patients with Episodic and Chronic Migraine: Analysis of a Randomized, Placebo-Controlled Trial and Open-label Extension Study. Neurol Ther. 2024 Jun;13(3):697-714. doi: 10.1007/s40120-024-00602-z. Epub 2024 Apr 6.
PubMed 38581615Shibata M, Nihira A, Tanji Y, Ozeki A, Imagawa H, Komori M. Galcanezumab Efficacy Through the Dosing Interval in Japanese Patients with Episodic Migraine: Post Hoc Analysis of a Phase 2 Randomized Trial. Neurol Ther. 2023 Dec;12(6):2007-2019. doi: 10.1007/s40120-023-00534-0. Epub 2023 Sep 12.
PubMed 37698836Igarashi H, Shibata M, Ozeki A, Matsumura T. Galcanezumab Effects on Migraine Severity and Symptoms in Japanese Patients with Episodic Migraine: Secondary Analysis of a Phase 2 Randomized Trial. Neurol Ther. 2023 Feb;12(1):73-87. doi: 10.1007/s40120-022-00410-3. Epub 2022 Oct 20.
PubMed 36266558Igarashi H, Shibata M, Ozeki A, Day KA, Matsumura T. Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine. J Pain Res. 2021 Nov 16;14:3555-3564. doi: 10.2147/JPR.S326905. eCollection 2021.
PubMed 34815708Tatsuoka Y, Takeshima T, Ozeki A, Matsumura T. Treatment Satisfaction of Galcanezumab in Japanese Patients with Episodic Migraine: A Phase 2 Randomized Controlled Study. Neurol Ther. 2021 Jun;10(1):265-278. doi: 10.1007/s40120-021-00236-5. Epub 2021 Apr 9.
PubMed 33835383Shibata M, Nakamura T, Ozeki A, Ueda K, Nichols RM. Migraine-Specific Quality-of-Life Questionnaire (MSQ) Version 2.1 Score Improvement in Japanese Patients with Episodic Migraine by Galcanezumab Treatment: Japan Phase 2 Study. J Pain Res. 2020 Dec 31;13:3531-3538. doi: 10.2147/JPR.S287781. eCollection 2020.
PubMed 33408512
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 (Galcanezumab) in Japanese Patients With Episodic Migraine
- ClinicalTrials.gov ID
- NCT02959177
- Acronym / sponsor ID
- 15796
- Conditions
- Migraine
- Keywords
- prevention, prophylaxis, headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Posted 21 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in Japanese participants with episodic migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 120 milligrams (mg) Galcanezumab | Experimental | Drug: Galcanezumab120 mg galcanezumab (LY2951742) administered subcutaneously (SC) once a month for 6 months. |
| 240 mg Galcanezumab | Experimental | Drug: Galcanezumab120 mg galcanezumab (LY2951742) administered SC once a month for 6 months. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC once a month for 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
Key exclusion criteria (4 listed)
- Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
- Current use or prior exposure to Galcanezumab or other antibodies to CGRP or its receptor.
- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
- History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GalcanezumabAlso: LY2951742Administered SC | Drug | 120 milligrams (mg) Galcanezumab, 240 mg Galcanezumab |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)
Time frame: Baseline, Month 1 through Month 6
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): 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; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; The overall mean is derived from the average of months 1 to 6 from mixed model repeat measures (MMRM) model. Least Square Mean (LSMEAN) was calculated using MMRM models with fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariates of baseline value and baseline-by-month interaction.
14 secondary outcomes
Percentage of Participants With a 50% or Greater Reduction From Baseline in Monthly Migraine Headache Days
Time frame: Baseline, Month 1 through Month 6
Percentage of Participants With a 75% or Greater Reduction From Baseline in Monthly Migraine Headache Days
Time frame: Baseline, Month 1 through Month 6
Percentage of Participants With a 100% Reduction From Baseline in Monthly Migraine Headache Days
Time frame: Baseline, Month 1 through Month 6
Overall Mean Change From Baseline on the Migraine-Specific Quality (MSQ) of Life Questionnaire
Time frame: Baseline, Month 4 through Month 6
Overall Mean Change From Baseline in Number of Migraine Headache Days With Acute Medication Use
Time frame: Baseline, Month 1 through Month 6
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
Time frame: Baseline, Month 4 through Month 6
Overall Mean Change From Baseline in Headache Hours
Time frame: Baseline, Month 1 through Month 6
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
Time frame: Baseline, Month 6
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Time frame: Month 6
Number of Participants With Suicidal Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
Time frame: Month 1 through Month 6
Number of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Time frame: Month 1 through Month 6
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab
Time frame: Baseline through Month 6
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Time frame: Month 6
Total Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38581615Takeshima T, Doi H, Ooba S, Tanji Y, Ozeki A, Komori M. Clinical Evaluation After Discontinuation of Galcanezumab in Japanese Patients with Episodic and Chronic Migraine: Analysis of a Randomized, Placebo-Controlled Trial and Open-label Extension Study. Neurol Ther. 2024 Jun;13(3):697-714. doi: 10.1007/s40120-024-00602-z. Epub 2024 Apr 6.
- Derived from this study: PubMed 37698836Shibata M, Nihira A, Tanji Y, Ozeki A, Imagawa H, Komori M. Galcanezumab Efficacy Through the Dosing Interval in Japanese Patients with Episodic Migraine: Post Hoc Analysis of a Phase 2 Randomized Trial. Neurol Ther. 2023 Dec;12(6):2007-2019. doi: 10.1007/s40120-023-00534-0. Epub 2023 Sep 12.
- Derived from this study: PubMed 36266558Igarashi H, Shibata M, Ozeki A, Matsumura T. Galcanezumab Effects on Migraine Severity and Symptoms in Japanese Patients with Episodic Migraine: Secondary Analysis of a Phase 2 Randomized Trial. Neurol Ther. 2023 Feb;12(1):73-87. doi: 10.1007/s40120-022-00410-3. Epub 2022 Oct 20.
- Derived from this study: PubMed 34815708Igarashi H, Shibata M, Ozeki A, Day KA, Matsumura T. Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine. J Pain Res. 2021 Nov 16;14:3555-3564. doi: 10.2147/JPR.S326905. eCollection 2021.
- Derived from this study: PubMed 33835383Tatsuoka Y, Takeshima T, Ozeki A, Matsumura T. Treatment Satisfaction of Galcanezumab in Japanese Patients with Episodic Migraine: A Phase 2 Randomized Controlled Study. Neurol Ther. 2021 Jun;10(1):265-278. doi: 10.1007/s40120-021-00236-5. Epub 2021 Apr 9.
- Derived from this study: PubMed 33408512Shibata M, Nakamura T, Ozeki A, Ueda K, Nichols RM. Migraine-Specific Quality-of-Life Questionnaire (MSQ) Version 2.1 Score Improvement in Japanese Patients with Episodic Migraine by Galcanezumab Treatment: Japan Phase 2 Study. J Pain Res. 2020 Dec 31;13:3531-3538. doi: 10.2147/JPR.S287781. eCollection 2020.
- Individual participant dataSharing planned: 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. .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Galcanezumab in people with Migraine, run by Eli Lilly and Company at 47 sites in Japan.
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 1 inclusion and 4 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 21 Feb 2020). 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 (MHD) (time frame: Baseline, Month 1 through Month 6). 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 NCT02959177, which also lists 6 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 27 Apr 2021.