Trial · NCT01125774

Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065)

NCT01125774, Phase 2, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2014-10-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065). Trials, record NCT01125774. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01125774

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065)
NCT number: NCT01125774
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 4,548 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Migraine
Interventions: Telcagepant, Placebo
First posted: 2010-05-18
Last updated: 2018-10-23
Results first posted: 2014-10-03

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Clinical Adverse Events (AEs)	Up to 14 days after the last dose of study drug (Up to 6.5 months)	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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.
Primary	Number of Participants Who Discontinued Study Due to a Clinical AE	Up to 6 months	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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.
Primary	Number of Participants With Laboratory AEs	Up to 6 months	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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.
Primary	Number of Participants Who Discontinued Study Due to a Laboratory AE	Up to 6 months	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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.
Primary	Mean Monthly Headache Days During Entire Study Period Among Participants With Menstrually-related Migraine (MRM) or Pure Menstrual Migraine (PMM) Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	Up to 6 months	Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM - In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.
Secondary	Mean Monthly Headache Days During Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	Up to 6 months	Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.
Secondary	Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM or PMM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	Up to 6 months	Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. "On-drug" headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM - In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.
Secondary	Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	Up to 6 months	Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. "On-drug" headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation additionally at other times of the cycle.
Secondary	Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With PMM Who Have an Average of 3 or More Moderate or Severe Migraine Headaches Per Month at Baseline	Up to 6 months	Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. "On-drug" headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. PMM participant subgroups (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Clinical Adverse Events (AEs)	Up to 14 days after the last dose of study drug (Up to 6.5 months)	All Participants as Treated (APaT) population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.	Participants	NUMBER
PRIMARY	Number of Participants Who Discontinued Study Due to a Clinical AE	Up to 6 months	APaT population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.	Participants	NUMBER
PRIMARY	Number of Participants With Laboratory AEs	Up to 6 months	APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.	Participants	NUMBER
PRIMARY	Number of Participants Who Discontinued Study Due to a Laboratory AE	Up to 6 months	APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.	Participants	NUMBER
PRIMARY	Mean Monthly Headache Days During Entire Study Period Among Participants With Menstrually-related Migraine (MRM) or Pure Menstrual Migraine (PMM) Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	Up to 6 months	All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.	Days per month	MEAN
SECONDARY	Mean Monthly Headache Days During Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	Up to 6 months	All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.	Days per month	MEAN
SECONDARY	Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM or PMM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	Up to 6 months	All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.	Days per month	MEAN
SECONDARY	Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	Up to 6 months	All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.	Days per month	MEAN
SECONDARY	Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With PMM Who Have an Average of 3 or More Moderate or Severe Migraine Headaches Per Month at Baseline	Up to 6 months	All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the PMM subgroup and reported average of ≥3 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.	Days per month	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Clinical Adverse Events (AEs)	Telcagepant 140 mg	1582	0.19	Participants
Number of Participants With Clinical Adverse Events (AEs)	Placebo	804	0.26	Participants
Number of Participants Who Discontinued Study Due to a Clinical AE	Telcagepant 140 mg	66	0.19	Participants
Number of Participants Who Discontinued Study Due to a Clinical AE	Placebo	36	0.26	Participants
Number of Participants With Laboratory AEs	Telcagepant 140 mg	76	0.19	Participants
Number of Participants With Laboratory AEs	Placebo	30	0.26	Participants
Number of Participants Who Discontinued Study Due to a Laboratory AE	Telcagepant 140 mg	8	0.19	Participants
Number of Participants Who Discontinued Study Due to a Laboratory AE	Placebo	2	0.26	Participants
Mean Monthly Headache Days During Entire Study Period Among Participants With Menstrually-related Migraine (MRM) or Pure Menstrual Migraine (PMM) Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	Telcagepant 140 mg	8.8	Standard Error 0.19	Days per month
Mean Monthly Headache Days During Entire Study Period Among Participants With Menstrually-related Migraine (MRM) or Pure Menstrual Migraine (PMM) Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline	Placebo	9.3	Standard Error 0.26	Days per month

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Telcagepant 140 mg - Excluding Duplicate Participants	3,018
Overall Study	STARTED	Placebo - Excluding Duplicate Participants	1,502
Overall Study	STARTED	Telcagepant 140 mg - Duplicate Participants	22
Overall Study	STARTED	Placebo - Duplicate Participants	6
Overall Study	Treated	Telcagepant 140 mg - Excluding Duplicate Participants	2,638
Overall Study	Treated	Placebo - Excluding Duplicate Participants	1,322
Overall Study	Treated	Telcagepant 140 mg - Duplicate Participants	21
Overall Study	Treated	Placebo - Duplicate Participants	5
Overall Study	COMPLETED	Telcagepant 140 mg - Excluding Duplicate Participants	1,893
Overall Study	COMPLETED	Placebo - Excluding Duplicate Participants	948

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events102

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	Diarrhoea	Gastrointestinal disorders	Telcagepant 140 mg	186	2,660	292
other	Diarrhoea	Gastrointestinal disorders	Placebo	90	1,326	128
other	Dry mouth	Gastrointestinal disorders	Telcagepant 140 mg	174	2,660	359
other	Dry mouth	Gastrointestinal disorders	Placebo	85	1,326	168
other	Nausea	Gastrointestinal disorders	Telcagepant 140 mg	270	2,660	467
other	Nausea	Gastrointestinal disorders	Placebo	165	1,326	264
other	Fatigue	General disorders	Telcagepant 140 mg	135	2,660	194
other	Fatigue	General disorders	Placebo	65	1,326	130
other	Nasopharyngitis	Infections and infestations	Telcagepant 140 mg	190	2,660	226
other	Nasopharyngitis	Infections and infestations	Placebo	102	1,326	122

1 to 10 of 102Source ClinicalTrials.gov

See all 102 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Telcagepant 140 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Telcagepant 140 mg	819	2,660
Total, other adverse events	Placebo	413	1,326
Total, serious adverse events	Telcagepant 140 mg	25	2,660
Total, serious adverse events	Placebo	10	1,326

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25926620	RESULT

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 comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Telcagepant 140 mg vs Placebo: Number of Participants With Laboratory AEs	Trial comparisons
Telcagepant 140 mg vs Placebo: Number of Participants With Clinical Adverse Events (AEs)	Trial comparisons
Telcagepant 140 mg vs Placebo: Number of Participants Who Discontinued Study Due to a Laboratory AE	Trial comparisons
Telcagepant 140 mg vs Placebo: Number of Participants Who Discontinued Study Due to a Clinical AE	Trial comparisons
Telcagepant 140 mg vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

GET https://conductscience.org/api/trials/v1/NCT01125774

GET https://conductscience.org/api/trials/v1/NCT01125774/events?page=2

API reference For AI assistants