Trial Outcomes & Findings for A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046) (NCT NCT00758836)
NCT ID: NCT00758836
Last Updated: 2018-10-22
Results Overview
Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
683 participants
Primary outcome timeframe
2 hours post-dose
Results posted on
2018-10-22
Participant Flow
Participant milestones
| Measure |
Placebo
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +Ibuprofen 400 mg
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +APAP 1000 mg
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
|
Telcagepant 280 mg
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
171
|
171
|
171
|
170
|
|
Overall Study
Treated
|
147
|
145
|
133
|
138
|
|
Overall Study
COMPLETED
|
147
|
145
|
133
|
138
|
|
Overall Study
NOT COMPLETED
|
24
|
26
|
38
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)
Baseline characteristics by cohort
| Measure |
Placebo
n=171 Participants
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +Ibuprofen 400 mg
n=171 Participants
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +APAP 1000 mg
n=171 Participants
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
|
Telcagepant 280 mg
n=170 Participants
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
|
Total
n=683 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<20 years
|
4 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
10 participants
n=31 Participants
|
|
Age, Customized
20-29 years
|
34 participants
n=99 Participants
|
43 participants
n=107 Participants
|
32 participants
n=206 Participants
|
33 participants
n=7 Participants
|
142 participants
n=31 Participants
|
|
Age, Customized
30-39 years
|
33 participants
n=99 Participants
|
47 participants
n=107 Participants
|
37 participants
n=206 Participants
|
53 participants
n=7 Participants
|
170 participants
n=31 Participants
|
|
Age, Customized
40-49 years
|
58 participants
n=99 Participants
|
51 participants
n=107 Participants
|
49 participants
n=206 Participants
|
51 participants
n=7 Participants
|
209 participants
n=31 Participants
|
|
Age, Customized
50-59 years
|
32 participants
n=99 Participants
|
19 participants
n=107 Participants
|
42 participants
n=206 Participants
|
23 participants
n=7 Participants
|
116 participants
n=31 Participants
|
|
Age, Customized
60-64 years
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
2 participants
n=7 Participants
|
18 participants
n=31 Participants
|
|
Age, Customized
>=65 years
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
2 participants
n=206 Participants
|
5 participants
n=7 Participants
|
18 participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
149 Participants
n=206 Participants
|
145 Participants
n=7 Participants
|
583 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
100 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 2 hours post-dosePopulation: The Full Analysis Set (FAS) comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.
Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +Ibuprofen 400 mg
n=145 Participants
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +APAP 1000 mg
n=133 Participants
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
|
Telcagepant 280 mg
n=138 Participants
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
|
|---|---|---|---|---|
|
Percentage of Participants With Pain Freedom at Two Hours Post-dose
|
10.9 Percentage of Participants
|
35.2 Percentage of Participants
|
38.3 Percentage of Participants
|
31.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 48 hours post-dosePopulation: All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +Ibuprofen 400 mg
n=145 Participants
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +APAP 1000 mg
n=133 Participants
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
|
Telcagepant 280 mg
n=137 Participants
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
|
|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)
|
27 Participants
|
44 Participants
|
42 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days post-dosePopulation: All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +Ibuprofen 400 mg
n=145 Participants
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +APAP 1000 mg
n=133 Participants
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
|
Telcagepant 280 mg
n=137 Participants
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
|
|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)
|
31 participants
|
46 participants
|
46 participants
|
37 participants
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: The FAS comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.
Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain relief was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0).
Outcome measures
| Measure |
Placebo
n=147 Participants
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +Ibuprofen 400 mg
n=145 Participants
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +APAP 1000 mg
n=133 Participants
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
|
Telcagepant 280 mg
n=138 Participants
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
|
|---|---|---|---|---|
|
Percentage of Participants With Pain Relief at 2 Hours Post-dose.
|
30.6 Percentage of Participants
|
71.0 Percentage of Participants
|
69.9 Percentage of Participants
|
65.2 Percentage of Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Telcagepant 280 mg +Ibuprofen 400 mg
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Telcagepant 280 mg +APAP 1000 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Telcagepant 280 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=148 participants at risk
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +Ibuprofen 400 mg
n=145 participants at risk
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
|
Telcagepant 280 mg +APAP 1000 mg
n=133 participants at risk
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
|
Telcagepant 280 mg
n=137 participants at risk
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.4%
8/148 • Number of events 8 • Up to 14 days after the dose was taken.
One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
|
6.2%
9/145 • Number of events 9 • Up to 14 days after the dose was taken.
One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
|
3.8%
5/133 • Number of events 5 • Up to 14 days after the dose was taken.
One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
|
4.4%
6/137 • Number of events 6 • Up to 14 days after the dose was taken.
One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
|
|
General disorders
Fatigue
|
0.68%
1/148 • Number of events 1 • Up to 14 days after the dose was taken.
One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
|
5.5%
8/145 • Number of events 9 • Up to 14 days after the dose was taken.
One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
|
5.3%
7/133 • Number of events 7 • Up to 14 days after the dose was taken.
One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
|
2.9%
4/137 • Number of events 4 • Up to 14 days after the dose was taken.
One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
|
|
Nervous system disorders
Somnolence
|
2.0%
3/148 • Number of events 3 • Up to 14 days after the dose was taken.
One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
|
5.5%
8/145 • Number of events 8 • Up to 14 days after the dose was taken.
One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
|
3.8%
5/133 • Number of events 5 • Up to 14 days after the dose was taken.
One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
|
4.4%
6/137 • Number of events 6 • Up to 14 days after the dose was taken.
One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
|
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