Trial Outcomes & Findings for MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049) (NCT NCT00797667)
NCT ID: NCT00797667
Last Updated: 2018-10-18
Results Overview
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (\>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
660 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2018-10-18
Participant Flow
Participant milestones
| Measure |
Telcagepant 140 mg
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Telcagepant 280 mg
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Placebo
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
265
|
264
|
131
|
|
Overall Study
Treated
|
263
|
263
|
130
|
|
Overall Study
COMPLETED
|
5
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
260
|
259
|
127
|
Reasons for withdrawal
| Measure |
Telcagepant 140 mg
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Telcagepant 280 mg
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Placebo
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
8
|
12
|
2
|
|
Overall Study
Physician Decision
|
3
|
1
|
0
|
|
Overall Study
Pregnancy
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
2
|
7
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
217
|
216
|
115
|
|
Overall Study
Withdrawal by Subject
|
9
|
14
|
2
|
|
Overall Study
Adverse Event
|
19
|
8
|
8
|
Baseline Characteristics
MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)
Baseline characteristics by cohort
| Measure |
Telcagepant 140 mg
n=263 Participants
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Telcagepant 280 mg
n=263 Participants
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Placebo
n=130 Participants
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Total
n=656 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
< 20 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Customized
20-29 years
|
54 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Age, Customized
30-39 years
|
52 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
|
Age, Customized
40-49 years
|
81 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Age, Customized
50-59 years
|
66 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Age, Customized
60-64 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
223 Participants
n=5 Participants
|
216 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
551 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (\>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.
Outcome measures
| Measure |
Telcagepant 140 mg
n=248 Participants
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Telcagepant 280 mg
n=247 Participants
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Placebo
n=125 Participants
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Mean Monthly Headache Days
|
-3.4 Days per month
Interval -3.9 to -2.8
|
-3.6 Days per month
Interval -4.1 to -3.1
|
-2.4 Days per month
Interval -3.2 to -1.7
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.
Outcome measures
| Measure |
Telcagepant 140 mg
n=248 Participants
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Telcagepant 280 mg
n=247 Participants
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Placebo
n=125 Participants
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in Mean Monthly Migraine Days
|
-3.0 Days per month
Interval -3.5 to -2.5
|
-3.4 Days per month
Interval -3.9 to -3.0
|
-2.3 Days per month
Interval -3.0 to -1.6
|
PRIMARY outcome
Timeframe: up to 14 days after last dose of study drug (up to 12 weeks)Population: All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.
Outcome measures
| Measure |
Telcagepant 140 mg
n=263 Participants
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Telcagepant 280 mg
n=265 Participants
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Placebo
n=128 Participants
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants Who Experienced an Adverse Event
|
52.5 Percentage of Participants
|
54.0 Percentage of Participants
|
57.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.
Outcome measures
| Measure |
Telcagepant 140 mg
n=263 Participants
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Telcagepant 280 mg
n=265 Participants
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Placebo
n=128 Participants
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event
|
8.0 Percentage of Participants
|
3.0 Percentage of Participants
|
7.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (\>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days. The percentage of participants who had at least a 50% reduction in mean monthly headache days during the 12 weeks treatment period was summarized
Outcome measures
| Measure |
Telcagepant 140 mg
n=248 Participants
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Telcagepant 280 mg
n=247 Participants
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Placebo
n=125 Participants
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days
|
36.7 Percentage of Participants
Interval 30.68 to 43.02
|
40.1 Percentage of Participants
Interval 33.92 to 46.48
|
25.6 Percentage of Participants
Interval 18.22 to 34.18
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.
Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache was accompanied with associated symptoms.( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. A migraine attack was defined as any migraine headache that occurs within 2 consecutive calendar days. Pain persisting for more than 2 days after its initial onset was considered a new, distinct migraine attack. The number of migraine attacks that occurred per month was calculated. Mean monthly rate was adjusted to 28 days.
Outcome measures
| Measure |
Telcagepant 140 mg
n=248 Participants
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Telcagepant 280 mg
n=247 Participants
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Placebo
n=125 Participants
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in the Mean Monthly Migraine Attacks
|
-2.1 attacks per month
Interval -2.4 to -1.7
|
-2.5 attacks per month
Interval -2.8 to -2.2
|
-1.7 attacks per month
Interval -2.2 to -1.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.
Participants completed a diary each evening just before going to bed. Information recorded included: date of assessment, administration of study medication, medication to treat breakthrough migraines and other headaches, associated symptoms, duration of headache pain, headache severity, and side effects. Participants use of medication to treat a breakthrough migraine/headache was considered rescue medication. The number of days per month requiring rescue medication was calculated.
Outcome measures
| Measure |
Telcagepant 140 mg
n=248 Participants
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Telcagepant 280 mg
n=248 Participants
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Placebo
n=125 Participants
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication
|
-3.0 Days per month
Interval -3.5 to -2.5
|
-3.2 Days per month
Interval -3.7 to -2.8
|
-1.7 Days per month
Interval -2.4 to -1.0
|
Adverse Events
MK-0974 140 mg
Serious events: 4 serious events
Other events: 61 other events
Deaths: 0 deaths
MK-0974 280 mg
Serious events: 3 serious events
Other events: 73 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-0974 140 mg
n=263 participants at risk
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
MK-0974 280 mg
n=265 participants at risk
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Placebo
n=128 participants at risk
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Colonic atony
|
0.00%
0/263 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.38%
1/265 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/128 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/263 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.38%
1/265 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/128 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/263 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.38%
1/265 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/128 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/263 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.38%
1/265 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/128 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Investigations
Hepatic enzyme increased
|
0.38%
1/263 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/265 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/128 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/263 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/265 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.78%
1/128 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/263 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.38%
1/265 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/128 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.38%
1/263 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/265 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/128 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Nervous system disorders
Coordination abnormal
|
0.38%
1/263 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/265 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/128 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Nervous system disorders
Migraine
|
0.38%
1/263 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/265 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/128 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Nervous system disorders
Speech disorder
|
0.38%
1/263 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/265 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/128 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Psychiatric disorders
Confusional state
|
0.38%
1/263 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/265 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/128 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Vascular disorders
Orthostatic hypotension
|
0.38%
1/263 • Number of events 1 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/265 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
0.00%
0/128 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
Other adverse events
| Measure |
MK-0974 140 mg
n=263 participants at risk
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
MK-0974 280 mg
n=265 participants at risk
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Placebo
n=128 participants at risk
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
21/263 • Number of events 26 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
3.4%
9/265 • Number of events 9 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
4.7%
6/128 • Number of events 6 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Gastrointestinal disorders
Nausea
|
11.8%
31/263 • Number of events 42 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
14.0%
37/265 • Number of events 42 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
5.5%
7/128 • Number of events 10 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
General disorders
Fatigue
|
4.2%
11/263 • Number of events 11 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
5.3%
14/265 • Number of events 14 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
8.6%
11/128 • Number of events 12 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
6/263 • Number of events 7 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
3.4%
9/265 • Number of events 10 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
9.4%
12/128 • Number of events 13 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Nervous system disorders
Dizziness
|
5.7%
15/263 • Number of events 26 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
6.0%
16/265 • Number of events 19 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
5.5%
7/128 • Number of events 13 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
|
Psychiatric disorders
Insomnia
|
2.3%
6/263 • Number of events 8 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
2.3%
6/265 • Number of events 6 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
5.5%
7/128 • Number of events 7 • up to 14 days after last dose of study drug (up to 12 weeks)
All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.
|
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. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER