Trial Outcomes & Findings for Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011) (NCT NCT00442936)

NCT ID: NCT00442936

Last Updated: 2018-10-17

Results Overview

Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1380 participants
• Primary outcome timeframe: 2 hours post-dose
• Results posted on: 2018-10-17

Participant Flow

Participant milestones

Measure	Telcagepant 150 mg Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Overall Study STARTED	333	354	345	348
Overall Study COMPLETED	332	354	344	347
Overall Study NOT COMPLETED	1	0	1	1

Reasons for withdrawal

Measure	Telcagepant 150 mg Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Overall Study Protocol Violation	1	0	1	1

Baseline Characteristics

Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)

Baseline characteristics by cohort

Measure	Telcagepant 150 mg n=333 Participants Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=354 Participants Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=345 Participants Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=348 Participants Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Total n=1380 Participants Total of all reporting groups
Age, Continuous	42.7 Years STANDARD_DEVIATION 11.2 • n=5 Participants	42.6 Years STANDARD_DEVIATION 11.4 • n=7 Participants	41.7 Years STANDARD_DEVIATION 11.7 • n=5 Participants	42.3 Years STANDARD_DEVIATION 11.6 • n=4 Participants	42.3 Years STANDARD_DEVIATION 11.4 • n=21 Participants
Sex: Female, Male Female	277 Participants n=5 Participants	300 Participants n=7 Participants	298 Participants n=5 Participants	294 Participants n=4 Participants	1169 Participants n=21 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	54 Participants n=7 Participants	47 Participants n=5 Participants	54 Participants n=4 Participants	211 Participants n=21 Participants

PRIMARY outcome

Timeframe: 2 hours post-dose

Population: The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.

Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose.

Outcome measures

Measure	Telcagepant 150 mg n=317 Participants Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=338 Participants Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=328 Participants Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=328 Participants Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose	56 Participants	89 Participants	101 Participants	29 Participants

PRIMARY outcome

Timeframe: 2 hours post-dose

Population: The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.

Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PR at 2 hours post-dose is defined as a shift from a moderate or severe migraine headache (Grade 2 or 3) at baseline to mild or no pain (Grade 1 or 0) at 2 hours post-dose.

Outcome measures

Measure	Telcagepant 150 mg n=317 Participants Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=338 Participants Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=328 Participants Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=328 Participants Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose	157 Participants	183 Participants	185 Participants	88 Participants

PRIMARY outcome

Timeframe: 2 hours post-dose

Population: The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline photophobia assessment, and had at least one photophobia assessment within 2 hours post-dose.

Participants were asked if they experienced any sensitivity to light. The number of participants who experienced no photophobia (sensitivity to light) at 2 hours post-dose was determined.

Outcome measures

Measure	Telcagepant 150 mg n=317 Participants Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=338 Participants Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=328 Participants Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=327 Participants Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Number of Participants With Absence of Photophobia at 2 Hours Post-Dose	143 Participants	169 Participants	163 Participants	92 Participants

PRIMARY outcome

Timeframe: 2 hours post-dose

Population: The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline phonophobia assessment, and had at least one phonophobia assessment within 2 hours post-dose.

Participants were asked if they experienced any sensitivity to sound. The number of participants who experienced no phonophobia (sensitivity to sound) at 2 hours post-dose was determined.

Outcome measures

Measure	Telcagepant 150 mg n=317 Participants Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=338 Participants Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=326 Participants Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=327 Participants Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose	170 Participants	193 Participants	180 Participants	120 Participants

PRIMARY outcome

Timeframe: 2 hours post-dose

Population: The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline nausea assessment, and had at least one nausea assessment within 2 hours post-dose.

Participants were asked if they experienced any nausea. The number of participants who experienced no nausea at 2 hours post-dose was determined.

Outcome measures

Measure	Telcagepant 150 mg n=316 Participants Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=337 Participants Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=327 Participants Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=327 Participants Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Number of Participants With Absence of Nausea at 2 Hours Post-Dose	212 Participants	218 Participants	232 Participants	179 Participants

PRIMARY outcome

Timeframe: Up to 14 days after last dose of study drug

Population: The population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 14 days after last dose study drug. Participants who took both active and placebo study drug were counted in the active group.

Outcome measures

Measure	Telcagepant 150 mg n=334 Participants Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=352 Participants Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=345 Participants Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=349 Participants Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Number of Participants Who Experience At Least One Adverse Event (AE)	105 Participants	131 Participants	175 Participants	112 Participants

PRIMARY outcome

Timeframe: Up to 48 hours after first dose of study drug

Population: The populaton consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants who took both active and placebo study drug were counted in the active group.

Outcome measures

Measure	Telcagepant 150 mg n=334 Participants Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=352 Participants Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=345 Participants Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=349 Participants Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Number of Participants Who Discontinue Study Drug Due to an AE	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 to 24 hours post-dose

Population: The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one pain score measurement at between 2 and 24 hours post-dose.

SPF is defined as PF at 2 hours post-dose with no return of mild/moderate/severe headache through 24 hours post-dose, and with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose.

Outcome measures

Measure	Telcagepant 150 mg n=314 Participants Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=336 Participants Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=328 Participants Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=328 Participants Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose	34 Participants	66 Participants	59 Participants	14 Participants

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 hours post-dose.

TMF at 2 hours post-dose is defined as PF at 2 hours post-dose without any of the following migraine-related symptoms: phonophobia, photophobia, nausea or vomiting at 2 hours post-dose.

Outcome measures

Measure	Telcagepant 150 mg n=317 Participants Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=338 Participants Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=328 Participants Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=328 Participants Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose	43 Participants	76 Participants	87 Participants	27 Participants

SECONDARY outcome

Timeframe: 2 to 24 hours post-dose

Population: The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 to 24 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 to 24 hours post-dose.

TMF at 2 to 24 hours post-dose is defined as TMF at 2 hours post-dose with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose, no return of mild/moderate/severe headache within 24 hours and no presence of phonophobia, photophobia, nausea or vomiting within 24 hours post-dose.

Outcome measures

Measure	Telcagepant 150 mg n=315 Participants Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=336 Participants Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=328 Participants Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=328 Participants Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose	26 Participants	57 Participants	51 Participants	13 Participants

Adverse Events

Telcagepant 150 mg

Serious events: 0 serious events

Other events: 66 other events

Deaths: 0 deaths

Telcagepant 300 mg

Serious events: 0 serious events

Other events: 74 other events

Deaths: 0 deaths

Zolmitriptan 5 mg

Serious events: 0 serious events

Other events: 107 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Measure	Telcagepant 150 mg n=334 participants at risk Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=352 participants at risk Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=345 participants at risk Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=349 participants at risk Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Musculoskeletal and connective tissue disorders Sensation of heaviness	0.00% 0/334 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	0.00% 0/352 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	0.00% 0/345 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	0.29% 1/349 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.

Other adverse events

Measure	Telcagepant 150 mg n=334 participants at risk Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.	Telcagepant 300 mg n=352 participants at risk Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.	Zolmitriptan 5 mg n=345 participants at risk Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.	Placebo n=349 participants at risk Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Gastrointestinal disorders Dry mouth	5.4% 18/334 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	6.0% 21/352 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	8.1% 28/345 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	3.7% 13/349 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.
Gastrointestinal disorders Nausea	3.9% 13/334 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	4.8% 17/352 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	5.8% 20/345 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	3.7% 13/349 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.
General disorders Fatigue	4.2% 14/334 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	4.3% 15/352 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	7.0% 24/345 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	2.3% 8/349 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.
Nervous system disorders Dizziness	4.5% 15/334 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	5.4% 19/352 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	11.0% 38/345 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	5.7% 20/349 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.
Nervous system disorders Paraesthesia	1.2% 4/334 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	1.7% 6/352 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	5.2% 18/345 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	1.4% 5/349 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.
Nervous system disorders Somnolence	4.5% 15/334 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	5.4% 19/352 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	5.8% 20/345 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.	4.0% 14/349 • Up to 14 days after last dose of study drug The All Participants as Treated population consisted of all participants who received at least 1 dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
• Publication restrictions are in place

Restriction type: OTHER