Migraines
Conditions
Keywords
multiple attacks of moderate to severe migraine headaches
Brief summary
The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.
Interventions
Telcagepant 140 mg tablets
DRUGTalcagepant 280 mg
Telcagepant 280 mg tablets
DRUGPlacebo
Placebo tablets
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of migraines within the past year * 1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated * Use acceptable contraception throughout the study * Able to complete the study questionnaire(s) and paper diary * Limit consumption of grapefruit juice to no more than one 8 ounce glass a day
Exclusion criteria
* Pregnant or breast-feeding or is expecting to become pregnant during the study * Difficulty distinguishing his/her migraine attacks from tension or interval headaches * A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours * More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months * Greater than 50 years old at the age of migraine onset * Previously taken telcagepant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack) | From 2 to 48 hours post-dose for the first migraine attack (up to 6 months) | Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 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 48 hours after dosing with the study medication. |
| Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack) | 2 hours post-dose for the first migraine attack (up to 6 months) | TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication. |
| Percentage of Participants Reporting Total Migraine 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) | TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication. |
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telcagepant 140 mg Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo. | 644 |
| Telcagepant 280 mg Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo. | 645 |
| Placebo The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose. | 646 |
| Total | 1,935 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Randomization | Lack of qualifying migraines | 21 | 25 | 31 |
| Randomization | Lost to Follow-up | 14 | 14 | 19 |
| Randomization | Physician Decision | 2 | 4 | 0 |
| Randomization | Pregnancy | 1 | 0 | 0 |
| Randomization | Progressive disease | 0 | 0 | 1 |
| Randomization | Protocol Violation | 14 | 25 | 22 |
| Randomization | Withdrawal by Subject | 19 | 28 | 18 |
| Treatment | Adverse Event | 3 | 5 | 4 |
| Treatment | Lack of Efficacy | 1 | 1 | 1 |
| Treatment | Lack of qualifying migraines | 101 | 99 | 116 |
| Treatment | Lost to Follow-up | 2 | 7 | 5 |
| Treatment | Physician Decision | 0 | 1 | 4 |
| Treatment | Pregnancy | 0 | 1 | 0 |
| Treatment | Protocol Violation | 6 | 3 | 5 |
| Treatment | Withdrawal by Subject | 16 | 12 | 21 |
Baseline characteristics
| Characteristic | Telcagepant 140 mg | Telcagepant 280 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 43.2 Years STANDARD_DEVIATION 11.7 | 42.6 Years STANDARD_DEVIATION 11.8 | 41.9 Years STANDARD_DEVIATION 11.7 | 42.6 Years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 542 Participants | 549 Participants | 540 Participants | 1631 Participants |
| Sex: Female, Male Male | 102 Participants | 96 Participants | 106 Participants | 304 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 166 / 573 | 144 / 543 | 138 / 561 |
| serious Total, serious adverse events | 8 / 573 | 8 / 543 | 4 / 561 |
Outcome results
Primary
Number of Participants Discontinuing Study Medication Due to an AE
Participants discontinuing study medication due to an AE were reported for all migraine attacks.
Time frame: Up to the 4th dose of study medication (up to 6 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Number of Participants Discontinuing Study Medication Due to an AE | 3 Participants |
| Telcagepant 280 mg | Number of Participants Discontinuing Study Medication Due to an AE | 5 Participants |
| Placebo | Number of Participants Discontinuing Study Medication Due to an AE | 4 Participants |
Primary
Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)
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.
Time frame: Up to 48 hours post-dose for the first migraine attack (up to 6 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack) | 179 Participants |
| Telcagepant 280 mg | Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack) | 167 Participants |
| Placebo | Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack) | 157 Participants |
Primary
Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)
The participant recorded whether nausea was present or absent at each of the predefined time points.
Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack) | 72.9 Percentage of participants |
| Telcagepant 280 mg | Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack) | 71.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack) | 62.8 Percentage of participants |
p-value: <0.00195% CI: [1.28, 2.17]Regression, Logistic
p-value: <0.00195% CI: [1.21, 2.04]Regression, Logistic
Primary
Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)
The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.
Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack) | 61.4 Percentage of participants |
| Telcagepant 280 mg | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack) | 59.4 Percentage of participants |
| Placebo | Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack) | 48.6 Percentage of participants |
p-value: <0.00195% CI: [1.36, 2.22]Regression, Logistic
p-value: <0.00195% CI: [1.26, 2.06]Regression, Logistic
Primary
Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)
The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.
Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack) | 52.3 Percentage of participants |
| Telcagepant 280 mg | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack) | 52.4 Percentage of participants |
| Placebo | Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack) | 40.6 Percentage of participants |
p-value: <0.00195% CI: [1.3, 2.11]Regression, Logistic
p-value: <0.00195% CI: [1.31, 2.14]Regression, Logistic
Primary
Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)
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.
Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) | 21.9 Percentage of participants |
| Telcagepant 280 mg | Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) | 25.1 Percentage of participants |
| Placebo | Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack) | 10.2 Percentage of participants |
p-value: <0.00195% CI: [1.8, 3.58]Regression, Logistic
p-value: <0.00195% CI: [2.15, 4.27]Regression, Logistic
Primary
Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose
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.
Time frame: 2 hours post-dose (up to 6 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose | 9.3 Percentage of participants |
| Telcagepant 280 mg | Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose | 14.1 Percentage of participants |
| Placebo | Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose | 2.7 Percentage of participants |
p-value: <0.00195% CI: [2.05, 7.23]Regression, Logistic
p-value: <0.00195% CI: [3.36, 11.39]Regression, Logistic
Primary
Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)
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.
Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack) | 58.6 Percentage of participants |
| Telcagepant 280 mg | Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack) | 56.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack) | 33.4 Percentage of participants |
p-value: <0.00195% CI: [2.35, 3.9]Regression, Logistic
p-value: <0.00195% CI: [2.17, 3.61]Regression, Logistic
Primary
Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose
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.
Time frame: 2 hours post-dose (up to 6 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose | 41.8 Percentage of participants |
| Telcagepant 280 mg | Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose | 46.8 Percentage of participants |
| Placebo | Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose | 22.3 Percentage of participants |
p-value: <0.00195% CI: [1.96, 3.51]Regression, Logistic
p-value: <0.00195% CI: [2.41, 4.34]Regression, Logistic
Secondary
Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
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.
Time frame: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) | 15.6 Percentage of participants |
| Telcagepant 280 mg | Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) | 19.1 Percentage of participants |
| Placebo | Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) | 6.5 Percentage of participants |
p-value: <0.00195% CI: [1.78, 4.07]Regression, Logistic
p-value: <0.00195% CI: [2.3, 5.19]Regression, Logistic
Secondary
Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)
Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 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 48 hours after dosing with the study medication.
Time frame: From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)
Population: 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 48 hrs, or a recurrence question.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack) | 13.4 Percentage of participants |
| Telcagepant 280 mg | Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack) | 17.9 Percentage of participants |
| Placebo | Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack) | 6.2 Percentage of participants |
p-value: <0.00195% CI: [1.56, 3.69]Regression, Logistic
p-value: <0.00195% CI: [2.22, 5.12]Regression, Logistic
Secondary
Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)
TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication.
Time frame: 2 hours post-dose for the first migraine attack (up to 6 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack) | 19.4 Percentage of participants |
| Telcagepant 280 mg | Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack) | 22.3 Percentage of participants |
| Placebo | Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack) | 9.5 Percentage of participants |
p-value: <0.00195% CI: [1.65, 3.38]Regression, Logistic
p-value: <0.00195% CI: [1.97, 4.01]Regression, Logistic
Secondary
Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication.
Time frame: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
Population: 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 24 hours.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telcagepant 140 mg | Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) | 13.7 Percentage of participants |
| Telcagepant 280 mg | Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) | 17.1 Percentage of participants |
| Placebo | Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack) | 6.5 Percentage of participants |
p-value: <0.00195% CI: [1.52, 3.54]Regression, Logistic
p-value: <0.00195% CI: [2, 4.56]Regression, Logistic