Trial · NCT00483704
Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)
NCT00483704, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2014-08-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031). Trials, record NCT00483704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00483704
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)
- NCT number
- NCT00483704
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,935 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Migraines
- Interventions
- Telcagepant 140 mg, Talcagepant 280 mg, Placebo
- First posted
- 2007-06-07
- Last updated
- 2018-10-18
- Results first posted
- 2014-08-29
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) | 2 hours post-dose for the first migraine attack (up to 6 months) | Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain. |
| Primary | Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack) | 2 hours post-dose for the first migraine attack (up to 6 months) | Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain. |
| Primary | Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose | 2 hours post-dose (up to 6 months) | Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC. |
| Primary | Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose | 2 hours post-dose (up to 6 months) | Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC. |
| Primary | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack) | 2 hours post-dose for the first migraine attack (up to 6 months) | The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points. |
| Primary | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack) | 2 hours post-dose for the first migraine attack (up to 6 months) | The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points. |
| Primary | Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack) | 2 hours post-dose for the first migraine attack (up to 6 months) | The participant recorded whether nausea was present or absent at each of the predefined time points. |
| Primary | Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack) | Up to 48 hours post-dose for the first migraine attack (up to 6 months) | AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups. |
| Primary | Number of Participants Discontinuing Study Medication Due to an AE | Up to the 4th dose of study medication (up to 6 months) | Participants discontinuing study medication due to an AE were reported for all migraine attacks. |
| Secondary | Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) | From 2 to 24 hours post-dose for the first migraine attack (up to 6 months) | Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration. SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) | 2 hours post-dose for the first migraine attack (up to 6 months) | The full-analysis set (FAS) included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack) | 2 hours post-dose for the first migraine attack (up to 6 months) | The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose | 2 hours post-dose (up to 6 months) | The modified FAS (MFAS) Population consisted of all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose | 2 hours post-dose (up to 6 months) | The MFAS Population was defined as all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack) | 2 hours post-dose for the first migraine attack (up to 6 months) | The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for photophobia severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline photophobia score or post-dose data through 2 hours. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack) | 2 hours post-dose for the first migraine attack (up to 6 months) | The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose phonophobia measurement prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline phonophobia score or post-dose data through 2 hours. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack) | 2 hours post-dose for the first migraine attack (up to 6 months) | The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for nausea severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline nausea score or post-dose data through 2 hours. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack) | Up to 48 hours post-dose for the first migraine attack (up to 6 months) | The All-Patients-as-Treated (APaT) Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication for the first migraine attack, they were included in that treatment group. | Participants | NUMBER |
| PRIMARY | Number of Participants Discontinuing Study Medication Due to an AE | Up to the 4th dose of study medication (up to 6 months) | The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group. | Participants | NUMBER |
| SECONDARY | Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) | From 2 to 24 hours post-dose for the first migraine attack (up to 6 months) | The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 24 hrs, or a recurrence question. | Percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) | Telcagepant 140 mg | 21.9 | Percentage of participants | ||
| Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) | Telcagepant 280 mg | 25.1 | Percentage of participants | ||
| Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) | Placebo | 10.2 | Percentage of participants | ||
| Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack) | Telcagepant 140 mg | 58.6 | Percentage of participants | ||
| Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack) | Telcagepant 280 mg | 56.7 | Percentage of participants | ||
| Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack) | Placebo | 33.4 | Percentage of participants | ||
| Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose | Telcagepant 140 mg | 9.3 | Percentage of participants | ||
| Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose | Telcagepant 280 mg | 14.1 | Percentage of participants | ||
| Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose | Placebo | 2.7 | Percentage of participants | ||
| Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose | Telcagepant 140 mg | 41.8 | Percentage of participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization | STARTED | Telcagepant 140 mg | 644 | |
| Randomization | STARTED | Telcagepant 280 mg | 645 | |
| Randomization | STARTED | Placebo | 646 | |
| Randomization | COMPLETED | Telcagepant 140 mg | 573 | |
| Randomization | COMPLETED | Telcagepant 280 mg | 549 | |
| Randomization | COMPLETED | Placebo | 555 | |
| Randomization | NOT COMPLETED | Telcagepant 140 mg | 71 | |
| Randomization | NOT COMPLETED | Telcagepant 280 mg | 96 | |
| Randomization | NOT COMPLETED | Placebo | 91 | |
| Treatment | STARTED | Telcagepant 140 mg | 573 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | Telcagepant 140 mg | 61 | 573 | 98 |
| other | Dry mouth | Gastrointestinal disorders | Telcagepant 280 mg | 42 | 543 | 82 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 53 | 561 | 105 |
| other | Nausea | Gastrointestinal disorders | Telcagepant 140 mg | 44 | 573 | 59 |
| other | Nausea | Gastrointestinal disorders | Telcagepant 280 mg | 47 | 543 | 65 |
| other | Nausea | Gastrointestinal disorders | Placebo | 37 | 561 | 54 |
| other | Fatigue | General disorders | Telcagepant 140 mg | 48 | 573 | 64 |
| other | Fatigue | General disorders | Telcagepant 280 mg | 34 | 543 | 43 |
| other | Fatigue | General disorders | Placebo | 27 | 561 | 44 |
| other | Dizziness | Nervous system disorders | Telcagepant 140 mg | 36 | 573 | 54 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Telcagepant 140 mg | ||
| Total, all-cause mortality | Telcagepant 280 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Telcagepant 140 mg | 166 | 573 |
| Total, other adverse events | Telcagepant 280 mg | 144 | 543 |
| Total, other adverse events | Placebo | 138 | 561 |
| Total, serious adverse events | Telcagepant 140 mg | 8 | 573 |
| Total, serious adverse events | Telcagepant 280 mg | 8 | 543 |
| Total, serious adverse events | Placebo | 4 | 561 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20974601 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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