Trial Outcomes & Findings for Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034) (NCT NCT00662818)
NCT ID: NCT00662818
Last Updated: 2018-10-19
Results Overview
Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). 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.
COMPLETED
PHASE3
165 participants
2 hours post-dose (Up to 6 weeks)
2018-10-19
Participant Flow
Participant milestones
| Measure |
Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg
Participants receive up to 12 doses of telcagepant (300 mg capsule/280 mg tablet), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
|
Placebo and APAP 1000 mg→Telcagepant 300 mg
Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
|
|---|---|---|
|
Period 1 (6 Weeks)
STARTED
|
84
|
81
|
|
Period 1 (6 Weeks)
Treated
|
56
|
58
|
|
Period 1 (6 Weeks)
COMPLETED
|
56
|
58
|
|
Period 1 (6 Weeks)
NOT COMPLETED
|
28
|
23
|
|
Wash-Out (14 Days)
STARTED
|
56
|
58
|
|
Wash-Out (14 Days)
COMPLETED
|
51
|
53
|
|
Wash-Out (14 Days)
NOT COMPLETED
|
5
|
5
|
|
Period 2 (6 Weeks)
STARTED
|
51
|
53
|
|
Period 2 (6 Weeks)
COMPLETED
|
38
|
41
|
|
Period 2 (6 Weeks)
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)
Baseline characteristics by cohort
| Measure |
Telcagepant 300 mg→APAP 1000 mg
n=56 Participants
Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
|
Placebo and APAP 1000 mg→Telcagepant 300 mg
n=58 Participants
Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
55.7 Years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
56.1 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours post-dose (Up to 6 weeks)Population: The full-analysis set (FAS) included participants treated for a migraine attack. Participants 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 (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). 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 300 mg
n=52 Participants
Participants receiving telcagepant
|
Placebo
n=53 Participants
Participants receiving placebo
|
|---|---|---|
|
Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)
|
25.0 Percentage of participants
Interval 14.0 to 38.9
|
18.9 Percentage of participants
Interval 9.4 to 32.0
|
PRIMARY outcome
Timeframe: Within 14 days of any dose of study medication (Up to 16 weeks)Population: All-Patients-as-Treated (APaT) population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
Telcagepant 300 mg
n=98 Participants
Participants receiving telcagepant
|
Placebo
n=86 Participants
Participants receiving placebo
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose
|
21 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Up to 48 hours post-dose (Up to 14 weeks)Population: The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
Telcagepant 300 mg
n=98 Participants
Participants receiving telcagepant
|
Placebo
n=86 Participants
Participants receiving placebo
|
|---|---|---|
|
Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 hours post-dose (Up to 6 weeks)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 300 mg
n=52 Participants
Participants receiving telcagepant
|
Placebo
n=53 Participants
Participants receiving placebo
|
|---|---|---|
|
Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)
|
63.5 Percentage of Participants
Interval 49.0 to 76.4
|
56.6 Percentage of Participants
Interval 42.3 to 70.2
|
SECONDARY outcome
Timeframe: Up to 48 hours after the dose of any study medication (Up to 14 weeks)Population: The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.
Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.
Outcome measures
| Measure |
Telcagepant 300 mg
n=98 Participants
Participants receiving telcagepant
|
Placebo
n=86 Participants
Participants receiving placebo
|
|---|---|---|
|
Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 hours post-dose (Up to 6 weeks)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 phonophobia 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 300 mg
n=52 Participants
Participants receiving telcagepant
|
Placebo
n=53 Participants
Participants receiving placebo
|
|---|---|---|
|
Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
|
65.4 Percentage of participants
Interval 50.9 to 78.0
|
58.5 Percentage of participants
Interval 44.1 to 71.9
|
SECONDARY outcome
Timeframe: 2 Hours post-dose (Up to 6 weeks)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 photophobia 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 300 mg
n=52 Participants
Participants receiving telcagepant
|
Placebo
n=53 Participants
Participants receiving placebo
|
|---|---|---|
|
Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
|
53.8 Percentage of Participants
Interval 39.5 to 67.8
|
58.5 Percentage of Participants
Interval 44.1 to 71.9
|
SECONDARY outcome
Timeframe: 2 hours post-dose (Up to 6 weeks)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 nausea 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 300 mg
n=52 Participants
Participants receiving telcagepant
|
Placebo
n=53 Participants
Participants receiving placebo
|
|---|---|---|
|
Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)
|
80.8 Percentage of Participants
Interval 67.5 to 90.4
|
69.8 Percentage of Participants
Interval 55.7 to 81.7
|
SECONDARY outcome
Timeframe: Up to 24 hours post-dose (Up to 14 weeks)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.
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 300 mg
n=52 Participants
Participants receiving telcagepant
|
Placebo
n=52 Participants
Participants receiving placebo
|
|---|---|---|
|
Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose
|
19.2 Percentage of Participants
Interval 9.6 to 32.5
|
15.4 Percentage of Participants
Interval 6.9 to 28.1
|
Adverse Events
Telcagepant
Acetaminophen/Paracetamol
Serious adverse events
| Measure |
Telcagepant
n=98 participants at risk
Participants receiving telcagepant
|
Acetaminophen/Paracetamol
n=86 participants at risk
Participants receiving acetaminophen/paracetamol
|
|---|---|---|
|
Psychiatric disorders
Psychotic disorder
|
1.0%
1/98 • Up to 48 hours post-dose (Up to 14 weeks)
|
0.00%
0/86 • Up to 48 hours post-dose (Up to 14 weeks)
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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