MigrainePhase 2NCT00758836

A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)

A Phase 2 study testing ibuprofen, acetominophen and telcagepant 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

Search all trials

Trial summary

This study will test the safety and how effective telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at least one drug combination is superior to telecagepant alone in the treatment of acute migraines. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Migraine
What is being tested?: ibuprofen, acetominophen and telcagepant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 683 participants
Where: No sites listed yet
Study dates: 3 Dec 2008to 24 Aug 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must be 18 years of age or older
History of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study
Willing to stay awake for at least 2 hours after taking study drug
Able to read, understand and complete questionnaires and diaries

Who cannot join

Breast-feeding, pregnant, or plan to become pregnant during the study
Not able to tell migraine attack from other headaches
Older than 50 years of age at migraine onset
Have more than 15 headache days per month or have taken medication for acute headache on more than 10 days per month in any of the 3 months before starting in the study
History of gastric or small intestinal surgery
History of heart attack, stroke, unstable angina, coronary artery bypass surgery or transient ischemic attack in the 3 months before starting in the study
Currently participating or have participated in a study with in investigational compound or device in the last 30 days

About this study

Official title: A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK0974 Co-administered With Ibuprofen or Acetaminophen in Patients With Migraine With or Without Aura

Conditions: Migraine
Being tested: placebo, ibuprofen, acetominophen, telcagepant
Medical subject headings: Migraine Disorders

What participants receive

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

placeboDrug
ibuprofenDrug
acetominophenDrug
Also called N-acetyl-p-aminophenol (APAP)
telcagepantDrug
Also called MK-0974

Study groups in NCT00758836
Study group	Role	What they receive
Placebo	Placebo comparator	Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine Receives: Drug: placebo
Telcagepant 280 mg +Ibuprofen 400 mg	Experimental	Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine Receives: Drug: ibuprofen; Drug: telcagepant
Telcagepant 280 mg +APAP 1000 mg	Experimental	Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine Receives: Drug: acetominophen; Drug: telcagepant
Telcagepant 280 mg	Placebo comparator	Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine Receives: Drug: telcagepant

What is being measured

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

Percentage of Participants With Pain Freedom at Two Hours Post-dose
Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).
Measured: 2 hours post-dose
Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Measured: Up to 48 hours post-dose
Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Measured: Up to 14 days post-dose

Secondary outcomes (1)

Percentage of Participants With Pain Relief at 2 Hours Post-dose.
Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain relief was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0).
Measured: 2 hours post-dose

Timeline

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

3 Dec 200824 Aug 2009

First posted25 Sep 2008 (estimated)
Study start3 Dec 2008
Primary completion24 Aug 2009
Study completion24 Aug 2009

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 683 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00758836
Sponsor's protocol ID: 0974-046
Other IDs: 2008_551, CTRI/2009/091/000291
Status last verified: Sep 2018
First submitted: 23 Sep 2008
Last updated: 22 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Hewitt DJ, Martin V, Lipton RB, Brandes J, Ceesay P, Gottwald R, Schaefer E, Lines C, Ho TW. Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine. Headache. 2011 Apr;51(4):533-43. doi: 10.1111/j.1526-4610.2011.01860.x.
PubMed 21457238

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 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK0974 Co-administered With Ibuprofen or Acetaminophen in Patients With Migraine With or Without Aura
ClinicalTrials.gov ID: NCT00758836
Acronym / sponsor ID: 0974-046
Conditions: Migraine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 683 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 3 Dec 2008 (actual)
Primary completion: 24 Aug 2009 (actual)
Study completion: 24 Aug 2009 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 11 Aug 2014

Clinical summary

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

Study design

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

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placeboParticipants take two placebo tablets and two placebo capsules, orally, at onset of migraine
Telcagepant 280 mg +Ibuprofen 400 mg	Experimental	Drug: ibuprofen, Drug: telcagepantParticipants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
Telcagepant 280 mg +APAP 1000 mg	Experimental	Drug: acetominophen, Drug: telcagepantParticipants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
Telcagepant 280 mg	Placebo comparator	Drug: telcagepantParticipants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine

Who may qualify

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

Key inclusion criteria (4 listed)

Must be 18 years of age or older
History of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study
Willing to stay awake for at least 2 hours after taking study drug
Able to read, understand and complete questionnaires and diaries

Key exclusion criteria (7 listed)

Breast-feeding, pregnant, or plan to become pregnant during the study
Not able to tell migraine attack from other headaches
Older than 50 years of age at migraine onset
Have more than 15 headache days per month or have taken medication for acute headache on more than 10 days per month in any of the 3 months before starting in the study
History of gastric or small intestinal surgery

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
placebo	Drug	Placebo
ibuprofen	Drug	Telcagepant 280 mg +Ibuprofen 400 mg
acetominophenAlso: N-acetyl-p-aminophenol (APAP)	Drug	Telcagepant 280 mg +APAP 1000 mg
telcagepantAlso: MK-0974	Drug	Telcagepant 280 mg, Telcagepant 280 mg +APAP 1000 mg, Telcagepant 280 mg +Ibuprofen 400 mg

Primary outcome

Percentage of Participants With Pain Freedom at Two Hours Post-dose
Time frame: 2 hours post-dose
Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).
Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)
Time frame: Up to 48 hours post-dose
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)
Time frame: Up to 14 days post-dose
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

1 secondary outcome

Percentage of Participants With Pain Relief at 2 Hours Post-dose.
Time frame: 2 hours post-dose

Results and safety

Results posted to the registry on 11 Aug 2014, 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	171	147
Telcagepant 280 mg +Ibuprofen 400 mg	171	145
Telcagepant 280 mg +APAP 1000 mg	171	133
Telcagepant 280 mg	170	138

Primary outcome: Percentage of Participants With Pain Freedom at Two Hours Post-dose

Time frame: 2 hours post-dose. Number. Unit: Percentage of Participants

Measure	Placebo n = 147	Telcagepant 280 mg +Ibuprofen 400 mg n = 145	Telcagepant 280 mg +APAP 1000 mg n = 133	Telcagepant 280 mg n = 138
Value	10.9	35.2	38.3	31.2

Placebo vs Telcagepant 280 mg +Ibuprofen 400 mg: Proportion difference: 24.5 (90% CI 16.7 to 32.2), p <0.001, Miettinen and Nurminen
Placebo vs Telcagepant 280 mg +APAP 1000 mg: Proportion difference: 27.7 (90% CI 19.6 to 35.8), p <0.001, Miettinen and Nurminen
Placebo vs Telcagepant 280 mg: Proportion difference: 20.4 (90% CI 12.6 to 28.2), p <0.001, Miettinen and Nurminen

Population analysed: The Full Analysis Set (FAS) comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.

Primary outcome: Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)

Time frame: Up to 48 hours post-dose. Number. Unit: Participants

Measure	Placebo n = 148	Telcagepant 280 mg +Ibuprofen 400 mg n = 145	Telcagepant 280 mg +APAP 1000 mg n = 133	Telcagepant 280 mg n = 137
Value	27	44	42	34

Population analysed: All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).

Primary outcome: Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)

Time frame: Up to 14 days post-dose. Number. Unit: participants

Measure	Placebo n = 148	Telcagepant 280 mg +Ibuprofen 400 mg n = 145	Telcagepant 280 mg +APAP 1000 mg n = 133	Telcagepant 280 mg n = 137
Value	31	46	46	37

Population analysed: All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 14 days after the dose was taken.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 148 (0%)	12 of 148 (8.1%)	Not reported
Telcagepant 280 mg +Ibuprofen 400 mg	0 of 145 (0%)	23 of 145 (15.9%)	Not reported
Telcagepant 280 mg +APAP 1000 mg	0 of 133 (0%)	16 of 133 (12%)	Not reported
Telcagepant 280 mg	0 of 137 (0%)	16 of 137 (11.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21457238Hewitt DJ, Martin V, Lipton RB, Brandes J, Ceesay P, Gottwald R, Schaefer E, Lines C, Ho TW. Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine. Headache. 2011 Apr;51(4):533-43. doi: 10.1111/j.1526-4610.2011.01860.x.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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 2 study testing ibuprofen, acetominophen and telcagepant 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 4 inclusion and 7 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 22 Oct 2018. 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 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 11 Aug 2014). 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?

Percentage of Participants With Pain Freedom at Two Hours Post-dose (time frame: 2 hours post-dose). The study lists 3 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 NCT00758836, 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 22 Oct 2018.