Migraine HeadachePhase 2NCT00804973

Study in Participants With Acute Migraines Headaches

A Phase 2 study testing LY2590443 and Sumatriptan in people with Migraine Headache, run by Eli Lilly and Company at 19 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Migraine Headache
What is being tested?: LY2590443 and Sumatriptan
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 19 sitesUnited States
Study dates: Nov 2008to May 2009
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female participants between the ages of 18 and 65 years, inclusive.
Participants who have migraine headaches, with or without aura (diagnosis according the International Classification of Headache Disorders-II), for at least 1 year.
Participants who have had 2-8 migraine attacks on average per month for the last 3 months (but less than 15 headache days per month).
Participants who are willing and able to comply with the study schedule and requirements.
Participants who speak, read, and understand English sufficiently well and are willing to provide written informed consent.
Participants who in the opinion of the principal investigator are in good general health.
Venous access should be sufficient to allow blood sampling as per protocol.

Who cannot join

Participants who do not or may not tolerate 5HT1 agonist treatments, with known hypersensitivity to sumatriptan (as discussed with the investigator).
Female participants who have a positive pregnancy test at screening or pre- dose evaluation, or are breastfeeding.
History or presence of significant medical illnesses as determined by the investigator.
Participants with a current clinical diagnosis of major psychiatric disease.
Regular use of known drugs of abuse; use of opiates for migraine rescue (no more than two times per month) is permissible.
Blood donation of 500 milliliter (mL) or greater of whole blood products within 4 weeks of study commencement, during the study, or 4 weeks following the study.

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Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Consumption of more than three units of alcohol per day where one unit is defined as a 12 ounces (oz) beer, 4 oz wine, or 2 oz of alcohol spirit liquor.
Are unwilling or unable to comply with the use of a diary to directly record data from the participant.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ann Arbor, Michigan, 48104
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Austin, Texas, 78759
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beverly Hills, California, 90211
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chicago, Illinois, 60625
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chula Vista, California, 91910
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fresno, California, 93720
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Garden Grove, California, 92845
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Houston, Texas, 77004
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Imperial, California, 92251
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Memphis, Tennessee, 38119
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mount Vernon, New York, 10550
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Norfolk, Virginia, 23502
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Philadelphia, Pennsylvania, 19107
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Diego, California, 92123
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Francisco, California, 94109
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santa Monica, California, 90404
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wellesley Hills, Massachusetts, 02481
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
West Chester, Ohio, 45069
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: A Safety, Tolerability, and Efficacy Study of LY2590443 in the Treatment of Acute Migraine Headache

This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines.

Conditions: Migraine Headache
Being tested: LY2590443, Placebo injection, Sumatriptan, Placebo capsule
Keywords: Migraine, 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.

LY2590443Drug
200 milligrams (mg) as four 50-mg capsules, oral, once
Placebo injectionDrug
saline solution, injection, once
SumatriptanDrug
6 milligrams (mg) injection (0.5 milliliter [mL] of 12 mg/mL solution), once
Placebo capsuleDrug
4 capsules, once

Study groups in NCT00804973
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: LY2590443; Drug: Placebo injection
2	Placebo comparator	Not described Receives: Drug: Placebo injection; Drug: Placebo capsule
3	Active comparator	Not described Receives: Drug: Sumatriptan; Drug: Placebo capsule

What is being measured

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

Number of Participants With Headache Pain Free Response
Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none." Headache pain free response was defined as the number of participants with a migraine pain intensity score of "none."
Measured: 2 hours after study drug administration

Secondary outcomes (9)

Number of Participants With Pain Free Response
Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate", "mild," or "none." Pain free response was defined as the number of participants with a migraine pain intensity score of "none."
Measured: 30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration
Number of Participants With Pain Relief Response
Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe", "moderate," "mild," or "none." Pain relief response was defined as the number of participants with a migraine pain intensity score of "none."
Measured: 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Sustained Pain Relief Response
Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none." Sustained pain relief response was defined as the number of participants with no return of a "moderate" or "severe" headache after pain went down to "mild" or "none" at 2 hours.
Measured: 24 and 48 hours after study drug administration
Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours
The time to headache recurrence is presented as the number of participants experiencing at least 1 recurring headache within 24 or 48 hours of receiving study drug.
Measured: Up to 24 and 48 hours after study drug administration
Number of Participants With Nausea
The number of participants reporting nausea as a migraine symptom
Measured: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Phonophobia
The number of participants reporting phonophobia as a migraine symptom
Measured: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Photophobia
The number of participants reporting photophobia as a migraine symptom
Measured: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Vomiting
The number of participants reporting vomiting as a migraine symptom
Measured: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Sustained Pain Free Response
Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none. Sustained pain free response was defined as the number of participants with no return of a "mild," "moderate" or "severe" headache after pain intensity went down to "none" at 2 hours.
Measured: 24 and 48 hours after study drug administration

Timeline

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

Nov 2008May 2009

First posted9 Dec 2008 (estimated)
Study startNov 2008
Primary completionMay 2009
Study completionMay 2009

Why it stopped: Due to efficacy results of interim analysis

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.
Other trials for Migraine 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00804973
Sponsor's protocol ID: 12258
Other IDs: I2W-MC-DMAB
Status last verified: May 2020
First submitted: 5 Dec 2008
Last updated: 19 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

All Migraine Headache trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety, Tolerability, and Efficacy Study of LY2590443 in the Treatment of Acute Migraine Headache
ClinicalTrials.gov ID: NCT00804973
Acronym / sponsor ID: 12258
Conditions: Migraine Headache
Keywords: Migraine, Headache
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to efficacy results of interim analysis
Enrolment: 120 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 9 Dec 2008 (estimated)
Results: Posted 19 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: LY2590443, Drug: Placebo injection
2	Placebo comparator	Drug: Placebo injection, Drug: Placebo capsule
3	Active comparator	Drug: Sumatriptan, Drug: Placebo capsule

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male and female participants between the ages of 18 and 65 years, inclusive.
Participants who have migraine headaches, with or without aura (diagnosis according the International Classification of Headache Disorders-II), for at least 1 year.
Participants who have had 2-8 migraine attacks on average per month for the last 3 months (but less than 15 headache days per month).
Participants who are willing and able to comply with the study schedule and requirements.
Participants who speak, read, and understand English sufficiently well and are willing to provide written informed consent.

Key exclusion criteria (9 listed)

Participants who do not or may not tolerate 5HT1 agonist treatments, with known hypersensitivity to sumatriptan (as discussed with the investigator).
Female participants who have a positive pregnancy test at screening or pre- dose evaluation, or are breastfeeding.
History or presence of significant medical illnesses as determined by the investigator.
Participants with a current clinical diagnosis of major psychiatric disease.
Regular use of known drugs of abuse; use of opiates for migraine rescue (no more than two times per month) is permissible.

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
LY2590443200 milligrams (mg) as four 50-mg capsules, oral, once	Drug	1
Placebo injectionsaline solution, injection, once	Drug	1, 2
Sumatriptan6 milligrams (mg) injection (0.5 milliliter [mL] of 12 mg/mL solution), once	Drug	3
Placebo capsule4 capsules, once	Drug	2, 3

Primary outcome

Number of Participants With Headache Pain Free Response
Time frame: 2 hours after study drug administration
Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none." Headache pain free response was defined as the number of participants with a migraine pain intensity score of "none."

9 secondary outcomes

Number of Participants With Pain Free Response
Time frame: 30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration
Number of Participants With Pain Relief Response
Time frame: 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Sustained Pain Relief Response
Time frame: 24 and 48 hours after study drug administration
Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours
Time frame: Up to 24 and 48 hours after study drug administration
Number of Participants With Nausea
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Phonophobia
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Photophobia
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Vomiting
Time frame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Sustained Pain Free Response
Time frame: 24 and 48 hours after study drug administration

Results and safety

Results posted to the registry on 19 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2590443	40	40
Sumatriptan	40	40
Placebo	40	40

Primary outcome: Number of Participants With Headache Pain Free Response

Time frame: 2 hours after study drug administration. Count of participants. Unit: Participants

Measure	LY2590443 n = 40	Sumatriptan n = 40	Placebo n = 40
Value	6	12	6

Population analysed: All participants who received at least 1 dose of study drug.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2590443	0 of 40 (0%)	13 of 40 (32.5%)	Not reported
Sumatriptan	0 of 40 (0%)	16 of 40 (40%)	Not reported
Placebo	0 of 40 (0%)	3 of 40 (7.5%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated at the end of Part 1 (due to lack of efficacy). Part 2 was not enrolled.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Migraine Headache

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

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 or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

19 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 LY2590443 and Sumatriptan in people with Migraine Headache, run by Eli Lilly and Company at 19 sites in United States.

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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. 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 19 May 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?

Number of Participants With Headache Pain Free Response (time frame: 2 hours after study drug administration). 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 NCT00804973.

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 19 May 2020.