MigrainePhase 3NCT00432237

Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)

A Phase 3 study testing MK0974 50 mg, MK0974 150 mg and MK0974 300 mg in people with Migraine, run by Merck Sharp & Dohme LLC.

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 purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Migraine
What is being tested?: MK0974 50 mg, MK0974 150 mg and MK0974 300 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,703 participants
Where: No sites listed yet
Study dates: Mar 2007to Dec 2007
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has at least 1 year history of migraine (with or without aura)
Females of childbearing years must use acceptable contraception throughout trial

Who cannot join

Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular disease
Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
Patient has a history of cancer within the last 5 years

About this study

Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Oral MK0974 in the Acute Treatment of Migraine With or Without Aura

The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine.

Conditions: Migraine
Being tested: MK0974 50 mg, MK0974 150 mg, MK0974 300 mg, Comparator: Placebo
Medical subject headings: Migraine Disorders

What participants receive

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

MK0974 50 mgDrug
Also called MK0974
MK0974 150 mgDrug
Also called MK0974
MK0974 300 mgDrug
Also called MK0974
Comparator: PlaceboDrug
MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.

Study groups in NCT00432237
Study group	Role	What they receive
MK0974 50 mg	Experimental	MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack Receives: Drug: MK0974 50 mg
MK0974 150 mg	Experimental	MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack Receives: Drug: MK0974 150 mg
MK0974 300 mg	Experimental	MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack Receives: Drug: MK0974 300 mg
Placebo	Placebo comparator	Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack Receives: Drug: Comparator: Placebo

What is being measured

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

Number of Patients Reporting Pain Freedom at 2 Hours Postdose
Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose.
Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.
Measured: 2 hours post dose
Number of Patients Reporting Pain Relief at 2 Hours Post Dose
Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose.
Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.
Measured: 2 hours post dose
Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose
Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.
Measured: 2 hours post dose
Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose
Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.
Measured: 2 hours post dose
Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose
Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.
Measured: 2 hours post dose

Secondary outcomes (3)

Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose
Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication.
Measured: 2 to 24 hours postdose
Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose
Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication.
Measured: 2 to 24 hours postdose
Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose
Pain Freedom and no migraine-associated symptoms at 2 hours postdose.
Measured: 2 hours postdose

Timeline

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

Mar 2007Dec 2007

First posted7 Feb 2007 (estimated)
Study startMar 2007
Primary completionDec 2007
Study completionDec 2007

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 (1)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: 1,703 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00432237
Sponsor's protocol ID: 0974-016
Other IDs: 2006_526
Status last verified: Jun 2015
First submitted: 5 Feb 2007
Last updated: 3 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Connor KM, Shapiro RE, Diener HC, Lucas S, Kost J, Fan X, Fei K, Assaid C, Lines C, Ho TW. Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology. 2009 Sep 22;73(12):970-7. doi: 10.1212/WNL.0b013e3181b87942.
PubMed 19770473

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?

Official record

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 trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Oral MK0974 in the Acute Treatment of Migraine With or Without Aura
ClinicalTrials.gov ID: NCT00432237
Acronym / sponsor ID: 0974-016
Conditions: Migraine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,703 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 7 Feb 2007 (estimated)
Results: Posted 6 Dec 2010

Clinical summary

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

The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
MK0974 50 mg	Experimental	Drug: MK0974 50 mgMK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
MK0974 150 mg	Experimental	Drug: MK0974 150 mgMK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
MK0974 300 mg	Experimental	Drug: MK0974 300 mgMK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
Placebo	Placebo comparator	Drug: Comparator: PlaceboPlacebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack

Who may qualify

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

Key inclusion criteria (2 listed)

Patient has at least 1 year history of migraine (with or without aura)
Females of childbearing years must use acceptable contraception throughout trial

Key exclusion criteria (5 listed)

Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular disease
Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
Patient has a history of cancer within the last 5 years

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
MK0974 50 mgAlso: MK0974	Drug	MK0974 50 mg
MK0974 150 mgAlso: MK0974	Drug	MK0974 150 mg
MK0974 300 mgAlso: MK0974	Drug	MK0974 300 mg
Comparator: PlaceboMK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.	Drug	Placebo

Primary outcome

Number of Patients Reporting Pain Freedom at 2 Hours Postdose
Time frame: 2 hours post dose
Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.
Number of Patients Reporting Pain Relief at 2 Hours Post Dose
Time frame: 2 hours post dose
Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.
Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose
Time frame: 2 hours post dose
Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.
Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose
Time frame: 2 hours post dose
Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.
Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose
Time frame: 2 hours post dose
Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.

3 secondary outcomes

Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose
Time frame: 2 to 24 hours postdose
Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose
Time frame: 2 to 24 hours postdose
Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose
Time frame: 2 hours postdose

Results and safety

Results posted to the registry on 6 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK0974 50 mg	244	177
MK0974 150 mg	485	384
MK0974 300 mg	484	375
Placebo	490	366

Primary outcome: Number of Patients Reporting Pain Freedom at 2 Hours Postdose

Time frame: 2 hours post dose. Number. Unit: Participants

Measure	MK0974 50 mg n = 176	MK0974 150 mg n = 380	MK0974 300 mg n = 369	Placebo n = 365
Value	29	88	88	39

MK0974 150 mg vs Placebo: p <0.001, Regression, Logistic
MK0974 300 mg vs Placebo: p <0.001, Regression, Logistic

Population analysed: All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.

Primary outcome: Number of Patients Reporting Pain Relief at 2 Hours Post Dose

Time frame: 2 hours post dose. Number. Unit: Participants

Measure	MK0974 50 mg n = 176	MK0974 150 mg n = 380	MK0974 300 mg n = 369	Placebo n = 365
Value	78	205	205	120

MK0974 150 mg vs Placebo: p <0.001, Regression, Logistic
MK0974 300 mg vs Placebo: p <0.001, Regression, Logistic

Population analysed: All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.

Primary outcome: Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose

Time frame: 2 hours post dose. Number. Unit: Participants

Measure	MK0974 50 mg n = 176	MK0974 150 mg n = 380	MK0974 300 mg n = 369	Placebo n = 365
Value	72	176	179	119

MK0974 150 mg vs Placebo: p <0.001, Regression, Logistic
MK0974 300 mg vs Placebo: p <0.001, Regression, Logistic

Population analysed: All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.

Primary outcome: Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose

Time frame: 2 hours post dose. Number. Unit: Participants

Measure	MK0974 50 mg n = 176	MK0974 150 mg n = 380	MK0974 300 mg n = 369	Placebo n = 365
Value	85	192	206	152

MK0974 150 mg vs Placebo: p <0.001, Regression, Logistic
MK0974 300 mg vs Placebo: p <0.001, Regression, Logistic

Population analysed: All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK0974 50 mg	0 of 177 (0%)	45 of 177 (25.4%)	Not reported
MK0974 150 mg	1 of 381 (0.3%)	69 of 381 (18.1%)	Not reported
MK0974 300 mg	0 of 370 (0%)	94 of 370 (25.4%)	Not reported
Placebo	1 of 366 (0.3%)	77 of 366 (21%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19770473Connor KM, Shapiro RE, Diener HC, Lucas S, Kost J, Fan X, Fei K, Assaid C, Lines C, Ho TW. Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology. 2009 Sep 22;73(12):970-7. doi: 10.1212/WNL.0b013e3181b87942.

Related trials for Migraine

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MK0974 50 mg, MK0974 150 mg and MK0974 300 mg in people with Migraine, run by Merck Sharp & Dohme LLC.

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 5 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 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

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 6 Dec 2010). 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 Patients Reporting Pain Freedom at 2 Hours Postdose (time frame: 2 hours post dose). The study lists 5 primary outcomes in all. 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 NCT00432237, which also lists 1 linked publication.

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 3 Jul 2015.