Trial Outcomes & Findings for Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031) (NCT NCT00483704)
NCT ID: NCT00483704
Last Updated: 2018-10-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1935 participants
Primary outcome timeframe
2 hours post-dose for the first migraine attack (up to 6 months)
Results posted on
2018-10-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Randomization
STARTED
|
644
|
645
|
646
|
|
Randomization
COMPLETED
|
573
|
549
|
555
|
|
Randomization
NOT COMPLETED
|
71
|
96
|
91
|
|
Treatment
STARTED
|
573
|
549
|
555
|
|
Treatment
COMPLETED
|
444
|
420
|
399
|
|
Treatment
NOT COMPLETED
|
129
|
129
|
156
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Randomization
Withdrawal by Subject
|
19
|
28
|
18
|
|
Randomization
Protocol Violation
|
14
|
25
|
22
|
|
Randomization
Lost to Follow-up
|
14
|
14
|
19
|
|
Randomization
Pregnancy
|
1
|
0
|
0
|
|
Randomization
Physician Decision
|
2
|
4
|
0
|
|
Randomization
Progressive disease
|
0
|
0
|
1
|
|
Randomization
Lack of qualifying migraines
|
21
|
25
|
31
|
|
Treatment
Lack of qualifying migraines
|
101
|
99
|
116
|
|
Treatment
Adverse Event
|
3
|
5
|
4
|
|
Treatment
Withdrawal by Subject
|
16
|
12
|
21
|
|
Treatment
Protocol Violation
|
6
|
3
|
5
|
|
Treatment
Lost to Follow-up
|
2
|
7
|
5
|
|
Treatment
Lack of Efficacy
|
1
|
1
|
1
|
|
Treatment
Pregnancy
|
0
|
1
|
0
|
|
Treatment
Physician Decision
|
0
|
1
|
4
|
Baseline Characteristics
Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)
Baseline characteristics by cohort
| Measure |
Telcagepant 140 mg
n=644 Participants
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.
|
Telcagepant 280 mg
n=645 Participants
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.
|
Placebo
n=646 Participants
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.
|
Total
n=1935 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.2 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
42.6 Years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
41.9 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
42.6 Years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
542 Participants
n=5 Participants
|
549 Participants
n=7 Participants
|
540 Participants
n=5 Participants
|
1631 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
304 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Telcagepant 280 mg
n=534 Participants
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.
|
Placebo
n=539 Participants
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.
|
Telcagepant 140 mg
n=556 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)
|
25.1 Percentage of participants
|
10.2 Percentage of participants
|
21.9 Percentage of participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Telcagepant 280 mg
n=534 Participants
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.
|
Placebo
n=539 Participants
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.
|
Telcagepant 140 mg
n=556 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)
|
56.7 Percentage of participants
|
33.4 Percentage of participants
|
58.6 Percentage of participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Telcagepant 280 mg
n=468 Participants
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.
|
Placebo
n=485 Participants
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.
|
Telcagepant 140 mg
n=493 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose
|
14.1 Percentage of participants
|
2.7 Percentage of participants
|
9.3 Percentage of participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Telcagepant 280 mg
n=440 Participants
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.
|
Placebo
n=452 Participants
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.
|
Telcagepant 140 mg
n=469 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose
|
46.8 Percentage of participants
|
22.3 Percentage of participants
|
41.8 Percentage of participants
|
PRIMARY outcome
Timeframe: 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.
The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.
Outcome measures
| Measure |
Telcagepant 280 mg
n=534 Participants
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.
|
Placebo
n=539 Participants
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.
|
Telcagepant 140 mg
n=554 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)
|
52.4 Percentage of participants
|
40.6 Percentage of participants
|
52.3 Percentage of participants
|
PRIMARY outcome
Timeframe: 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.
The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.
Outcome measures
| Measure |
Telcagepant 280 mg
n=534 Participants
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.
|
Placebo
n=537 Participants
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.
|
Telcagepant 140 mg
n=555 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)
|
59.4 Percentage of participants
|
48.6 Percentage of participants
|
61.4 Percentage of participants
|
PRIMARY outcome
Timeframe: 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.
The participant recorded whether nausea was present or absent at each of the predefined time points.
Outcome measures
| Measure |
Telcagepant 280 mg
n=534 Participants
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.
|
Placebo
n=538 Participants
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.
|
Telcagepant 140 mg
n=553 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)
|
71.7 Percentage of participants
|
62.8 Percentage of participants
|
72.9 Percentage of participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Telcagepant 280 mg
n=538 Participants
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.
|
Placebo
n=564 Participants
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.
|
Telcagepant 140 mg
n=575 Participants
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.
|
|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)
|
167 Participants
|
157 Participants
|
179 Participants
|
PRIMARY outcome
Timeframe: 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.
Participants discontinuing study medication due to an AE were reported for all migraine attacks.
Outcome measures
| Measure |
Telcagepant 280 mg
n=543 Participants
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.
|
Placebo
n=561 Participants
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.
|
Telcagepant 140 mg
n=573 Participants
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.
|
|---|---|---|---|
|
Number of Participants Discontinuing Study Medication Due to an AE
|
5 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Telcagepant 280 mg
n=529 Participants
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.
|
Placebo
n=537 Participants
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.
|
Telcagepant 140 mg
n=553 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
|
19.1 Percentage of participants
|
6.5 Percentage of participants
|
15.6 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Telcagepant 280 mg
n=526 Participants
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.
|
Placebo
n=536 Participants
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.
|
Telcagepant 140 mg
n=552 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)
|
17.9 Percentage of participants
|
6.2 Percentage of participants
|
13.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Telcagepant 280 mg
n=534 Participants
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.
|
Placebo
n=539 Participants
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.
|
Telcagepant 140 mg
n=556 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)
|
22.3 Percentage of participants
|
9.5 Percentage of participants
|
19.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Telcagepant 280 mg
n=531 Participants
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.
|
Placebo
n=537 Participants
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.
|
Telcagepant 140 mg
n=553 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
|
17.1 Percentage of participants
|
6.5 Percentage of participants
|
13.7 Percentage of participants
|
Adverse Events
Telcagepant 140 mg
Serious events: 8 serious events
Other events: 166 other events
Deaths: 0 deaths
Telcagepant 280 mg
Serious events: 8 serious events
Other events: 144 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 138 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telcagepant 140 mg
n=573 participants at risk
Participants who received at least one dose of telcagepant 140 mg.
|
Telcagepant 280 mg
n=543 participants at risk
Participants who received at least one dose of telcagepant 280 mg.
|
Placebo
n=561 participants at risk
Participants who received at least one dose of placebo.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.17%
1/573 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/543 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/543 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.17%
1/573 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/543 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.17%
1/573 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/543 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/543 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/561 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/543 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Infections and infestations
Pneumonia
|
0.17%
1/573 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/543 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Investigations
Platelet count increased
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/543 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/561 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/543 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/561 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/543 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.17%
1/573 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/543 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/543 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/543 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/561 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/543 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/561 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Nervous system disorders
Migraine
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.55%
3/543 • Number of events 3 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/543 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.17%
1/573 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/543 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/543 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Vascular disorders
Aneurysm
|
0.17%
1/573 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/543 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/573 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.18%
1/543 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Infections and infestations
Subcutaneous abscess
|
0.17%
1/573 • Number of events 1 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/543 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
0.00%
0/561 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
Other adverse events
| Measure |
Telcagepant 140 mg
n=573 participants at risk
Participants who received at least one dose of telcagepant 140 mg.
|
Telcagepant 280 mg
n=543 participants at risk
Participants who received at least one dose of telcagepant 280 mg.
|
Placebo
n=561 participants at risk
Participants who received at least one dose of placebo.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
10.6%
61/573 • Number of events 98 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
7.7%
42/543 • Number of events 82 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
9.4%
53/561 • Number of events 105 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
44/573 • Number of events 59 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
8.7%
47/543 • Number of events 65 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
6.6%
37/561 • Number of events 54 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
General disorders
Fatigue
|
8.4%
48/573 • Number of events 64 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
6.3%
34/543 • Number of events 43 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
4.8%
27/561 • Number of events 44 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Nervous system disorders
Dizziness
|
6.3%
36/573 • Number of events 54 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
7.4%
40/543 • Number of events 57 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
7.1%
40/561 • Number of events 59 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
|
Nervous system disorders
Somnolence
|
6.3%
36/573 • Number of events 54 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
5.9%
32/543 • Number of events 49 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
2.7%
15/561 • Number of events 26 • Up to 14 days post-dose (up to 6 1/2 months)
The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
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. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER