Chronic Cluster HeadachePhase 3NCT02438826

A Study of Galcanezumab in Participants With Chronic Cluster Headache

A Phase 3 study testing Galcanezumab 300 mg in people with Chronic Cluster Headache, run by Eli Lilly and Company at 48 sites in 12 countries.

Completed

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

Official record

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Trial summary

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Cluster Headache
What is being tested?: Galcanezumab 300 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: 48 sitesin 12 countries
Study dates: 18 Jun 2015to 14 Aug 2019
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 with a history of chronic cluster headache occurring without a remission period, or with remissions lasting <1 month, for at least 1 year.
Participants are able to distinguish cluster headache attacks from other headaches.

Who cannot join

Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.
Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.
A history of migraine variants that could implicate or could be confused with ischemia.
Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.
A history or presence of other medical illness that indicates a medical problem that would preclude study participation.
Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.
Women who are pregnant or nursing.

Trial locations and contacts

48 sites in 12 countries.

Country

City, postcode or hospital

48 sites in 12 countries

United States14 sites

Michigan Head, Pain and Neurological Institute
Ann Arbor, Michigan, 48104
Northwest Clinical Research Center
Bellevue, Washington, 98007-4209
Southwestern Medical Center - Dallas
Dallas, Texas, 75390
Colorado Neurological Institute
Englewood, Colorado, 80113
Mayo Clinic-Jacksonville
Jacksonville, Florida, 32224
West Virginia University Hospital
Morgantown, West Virginia, 26506
Yale University School of Medicine
New Haven, Connecticut, 06510
Yale University School of Medicine
New Haven, Connecticut, 06519
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic Hospital
Phoenix, Arizona, 85054
California Medical Clinic for Headache
Santa Monica, California, 90404
New England Institute for Clinical Research
Stamford, Connecticut, 06905
Stanford University Hospital
Stanford, California, 94304
Tampa General Hospital
Tampa, Florida, 33606

Other trials in United States

France6 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Lille, 59037
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Marseille, 13385
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Nice, 06003
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Paris, 75010
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Paris, 75475
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Saint-Etienne, 42055

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Germany6 sites

Praxis Dr. Stude
Bochum, 44787
Universtitätsklinikum Essen AöR
Essen, 45147
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Hamburg, 20246
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Jena, 07747
Migräne- und Kopfschmerzklinik GmbH & Co. KG
Königstein, 61462
Klinikum der Universität München Campus Großhadern
München, 81377

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United Kingdom4 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Hull, HU3 2JZ
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Liverpool, L9 7LJ
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London, SE5 9RS
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Stoke-on-Trent, ST4 6QG

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Canada3 sites

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Montreal, H2L 4M1
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Montreal, H2W 1V1
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Toronto, M4S 1Y2

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Italy3 sites

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Florence, 50134
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Milan, 20133
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Pavia, 27100

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Belgium2 sites

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Ghent, 9000
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Liège, 4000

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Denmark2 sites

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Glostrup Municipality, 2600
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Glostrup Municipality, 2600

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Finland2 sites

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Helsinki, 00930
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Turku, 20100

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Greece2 sites

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Athens, 11525
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Athens, 11528

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Netherlands2 sites

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Amsterdam, 1078w
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Nijmegen, 6532 SZ

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Spain2 sites

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Barcelona, 08035
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Valencia, 46010

Other trials in Spain

About this study

Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of : Galcanezumab (LY2951742) With a Long-Term Open-Label Extension in Patients With Chronic Cluster Headache

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.

Conditions: Chronic Cluster Headache
Being tested: Galcanezumab 300 mg, Placebo
Medical subject headings: Cluster Headache

What participants receive

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

Galcanezumab 300 mgDrug
Also called LY2951742
Administered SC
PlaceboDrug
Administered SC

Study groups in NCT02438826
Study group	Role	What they receive
Galcanezumab 300 mg	Experimental	Double-Blind Treatment Phase: Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations. Receives: Drug: Galcanezumab 300 mg
Placebo	Placebo comparator	Double-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations. Receives: Drug: Galcanezumab 300 mg; 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 Weekly Cluster Headache Attack Frequency
Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 12 weeks of daily data during double-blind treatment phase will be converted into 14-calendar day intervals: the baseline 14-day interval, Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Next, the biweekly interval results were adjusted to 7-day (weekly) interval in order to report the outcome as weekly frequency. Overall mean change from baseline is derived from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, verapamil use, pooled investigative site, week, baseline, and treatment by week as fixed effects.
Measured: Baseline, Week 1 through Week 12

Secondary outcomes (13)

Percentage of Participants With a 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
A 50% responder is any participant who has a ≥50% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval: Weeks 1/2, Weeks 3/4, Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects.
Measured: Baseline, Week 1 through Week 12
Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
Sustained Response is defined as a 50% or greater reduction in the weekly cluster attack frequency from baseline to Weeks 3/4 and maintained at Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Percentage of participants with a sustained response was analyzed using Koch's nonparametric randomization-based analysis of covariance method. This method adjusted for pooled investigative site by including it as a stratification variable. It also adjusted for sex, verapamil use and baseline value.
Measured: Baseline, Week 3 through Week 12
Percentage of Participants With a 30% Reduction in the Weekly Number of Cluster Headache Attacks
A 30% responder is any participant who has a ≥30% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval. Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects. .
Measured: Baseline, Week 1 through Week 12
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Measured: Week 4
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Measured: Week 8
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Measured: Week 12
Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation: 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: Week 1 through Week 12
Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Measured: Week 1 through Week 12
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742)
Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject 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+ if there is at least one post-baseline result of ADA present with titer >= 1: 20.
Measured: Baseline, Week 1 through Week 12
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Measured: Week 2
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Measured: Week 4
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Measured: Week 8
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Measured: Week 12

Timeline

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

18 Jun 201514 Aug 2019

First posted8 May 2015 (estimated)
Study start18 Jun 2015
Primary completion27 Mar 2018
Study completion14 Aug 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 (2)Papers the sponsor has linked to this study.
Other trials for Chronic Cluster HeadacheStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02438826
Sponsor's protocol ID: 15781
Other IDs: I5Q-MC-CGAM, 2014-005429-11, 2014
Status last verified: Jun 2020
First submitted: 6 May 2015
Last updated: 25 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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

Jensen RH, Tassorelli C, Myers Oakes TM, Bardos JN, Zhou C, Dong Y, Aurora SK, Martinez JM. Baseline demographics and disease characteristics of patients with episodic or chronic cluster headache: data from two phase 3 randomized clinical trials in Europe and North America. Front Neurol. 2023 Dec 15;14:1293163. doi: 10.3389/fneur.2023.1293163. eCollection 2023.
PubMed 38162453
Dodick DW, Goadsby PJ, Lucas C, Jensen R, Bardos JN, Martinez JM, Zhou C, Aurora SK, Yang JY, Conley RR, Oakes T. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment. Cephalalgia. 2020 Aug;40(9):935-948. doi: 10.1177/0333102420905321. Epub 2020 Feb 12.
PubMed 32050782

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of : Galcanezumab (LY2951742) With a Long-Term Open-Label Extension in Patients With Chronic Cluster Headache
ClinicalTrials.gov ID: NCT02438826
Acronym / sponsor ID: 15781
Conditions: Chronic Cluster Headache
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 18 Jun 2015 (actual)
Primary completion: 27 Mar 2018 (actual)
Study completion: 14 Aug 2019 (actual)
First posted: 8 May 2015 (estimated)
Results: Posted 11 Jun 2019

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 evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Galcanezumab 300 mg	Experimental	Drug: Galcanezumab 300 mgDouble-Blind Treatment Phase: Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.
Placebo	Placebo comparator	Drug: Galcanezumab 300 mg, Drug: PlaceboDouble-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participants with a history of chronic cluster headache occurring without a remission period, or with remissions lasting <1 month, for at least 1 year.
Participants are able to distinguish cluster headache attacks from other headaches.

Key exclusion criteria (8 listed)

Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.
Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.
A history of migraine variants that could implicate or could be confused with ischemia.
Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.

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
Galcanezumab 300 mgAlso: LY2951742Administered SC	Drug	Galcanezumab 300 mg, Placebo
PlaceboAdministered SC	Drug	Placebo

Primary outcome

Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency
Time frame: Baseline, Week 1 through Week 12
Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 12 weeks of daily data during double-blind treatment phase will be converted into 14-calendar day intervals: the baseline 14-day interval, Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Next, the biweekly interval results were adjusted to 7-day (weekly) interval in order to report the outcome as weekly frequency. Overall mean change from baseline is derived from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, verapamil use, pooled investigative site, week, baseline, and treatment by week as fixed effects.

13 secondary outcomes

Percentage of Participants With a 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
Time frame: Baseline, Week 1 through Week 12
Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
Time frame: Baseline, Week 3 through Week 12
Percentage of Participants With a 30% Reduction in the Weekly Number of Cluster Headache Attacks
Time frame: Baseline, Week 1 through Week 12
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
Time frame: Week 4
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
Time frame: Week 8
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
Time frame: Week 12
Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Time frame: Week 1 through Week 12
Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Time frame: Week 1 through Week 12
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742)
Time frame: Baseline, Week 1 through Week 12
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Time frame: Week 2
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Time frame: Week 4
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Time frame: Week 8
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Time frame: Week 12

Results and safety

Results posted to the registry on 11 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo/Galcanezumab (GMB) 300 mg	123	117
GMB 300 mg/GMB 300 mg	117	113
Placebo (Post-Treatment Phase)	0	0
Galcanezumab 300 mg (Post-Treatment Phase)	0	0

Primary outcome: Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency

Time frame: Baseline, Week 1 through Week 12. Least squares mean (Standard Error). Unit: cluster headache attacks per week

Measure	Placebo n = 120	Galcanezumab 300 mg n = 117
Value	-4.59 (0.79)	-5.38 (0.81)

Placebo vs Galcanezumab 300 mg: LSMean Difference: -0.80 (95% CI -2.77 to 1.17), p = 0.334, Mixed Models Analysis

Population analysed: All randomized participants who received at least 1 dose of study drug, and had baseline and at least one post baseline value.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 Year 7 Months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Double-Blind Treatment Phase)	3 of 120 (2.5%)	60 of 120 (50%)	0 of 120
Galcanezumab 300 mg (Double-Blind Treatment Phase)	2 of 117 (1.7%)	68 of 117 (58.1%)	0 of 117
Placebo/GMB 300 mg (Open-Label Treatment Phase)	11 of 116 (9.5%)	69 of 116 (59.5%)	0 of 116
GMB 300 mg/GMB 300 mg (Open-Label Treatment Phase)	10 of 113 (8.8%)	72 of 113 (63.7%)	0 of 113
Placebo (Post-Treatment Phase)	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Galcanezumab 300 mg (Post-Treatment Phase)	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Placebo/GMB 300 mg (Post-Treatment Phase)	0 of 93 (0%)	18 of 93 (19.4%)	0 of 93
GMB 300 mg/GMB 300 Mg-Post-Treatment Phase	5 of 93 (5.4%)	16 of 93 (17.2%)	0 of 93

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38162453Jensen RH, Tassorelli C, Myers Oakes TM, Bardos JN, Zhou C, Dong Y, Aurora SK, Martinez JM. Baseline demographics and disease characteristics of patients with episodic or chronic cluster headache: data from two phase 3 randomized clinical trials in Europe and North America. Front Neurol. 2023 Dec 15;14:1293163. doi: 10.3389/fneur.2023.1293163. eCollection 2023.
Derived from this study: PubMed 32050782Dodick DW, Goadsby PJ, Lucas C, Jensen R, Bardos JN, Martinez JM, Zhou C, Aurora SK, Yang JY, Conley RR, Oakes T. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment. Cephalalgia. 2020 Aug;40(9):935-948. doi: 10.1177/0333102420905321. Epub 2020 Feb 12.
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

48 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Galcanezumab 300 mg in people with Chronic Cluster Headache, run by Eli Lilly and Company at 48 sites in 12 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 8 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, France, Germany, United Kingdom, Canada and 7 more countries. 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 11 Jun 2019). 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 Weekly Cluster Headache Attack Frequency (time frame: Baseline, Week 1 through Week 12). 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 NCT02438826, 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 25 Aug 2020.