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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_551 | Other Identifier | Merck Registration Number | |
| CTRI/2009/091/000291 | Registry Identifier | CTRI |
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This study will test the safety and how effective telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at least one drug combination is superior to telecagepant alone in the treatment of acute migraines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine |
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| Telcagepant 280 mg +Ibuprofen 400 mg | Experimental | Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine |
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| Telcagepant 280 mg +APAP 1000 mg | Experimental | Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine |
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| Telcagepant 280 mg | Placebo Comparator | Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug |
| ||
| ibuprofen |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pain Freedom at Two Hours Post-dose | 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). | 2 hours post-dose |
| Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups) | 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. | Up to 48 hours post-dose |
| Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups) | 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. | Up to 14 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pain Relief at 2 Hours Post-dose. | 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). | 2 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21457238 | Derived | Hewitt DJ, Martin V, Lipton RB, Brandes J, Ceesay P, Gottwald R, Schaefer E, Lines C, Ho TW. Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine. Headache. 2011 Apr;51(4):533-43. doi: 10.1111/j.1526-4610.2011.01860.x. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| acetominophen | Drug |
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| telcagepant | Drug |
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| FG002 | 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 |
| FG003 | Telcagepant 280 mg | Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Telcagepant 280 mg | Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Pain Freedom at Two Hours Post-dose | 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). | 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. | Posted | Number | Percentage of Participants | 2 hours post-dose |
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| Secondary | Percentage of Participants With Pain Relief at 2 Hours Post-dose. | 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). | 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. | Posted | Number | Percentage of Participants | 2 hours post-dose |
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| Primary | Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups) | 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. | 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). | Posted | Number | Participants | Up to 48 hours post-dose |
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| Primary | Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups) | 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. | 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). | Posted | Number | participants | Up to 14 days post-dose |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine | 0 | 148 | 12 | 148 | ||
| EG001 | 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 | 0 | 145 | 23 | 145 | ||
| EG002 | 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 | 0 | 133 | 16 | 133 | ||
| EG003 | Telcagepant 280 mg | Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine | 0 | 137 | 16 | 137 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| C525458 | telcagepant |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| 20-29 years |
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| 30-39 years |
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| 40-49 years |
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| 50-59 years |
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| 60-64 years |
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| >=65 years |
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| Male |
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Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity. |
| <0.001 |
| Proportion difference |
| 27.7 |
| 2-Sided |
| 90 |
| 19.6 |
| 35.8 |
| Superiority or Other |
| Miettinen and Nurminen | Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity. | <0.001 | Proportion difference | 20.4 | 2-Sided | 90 | 12.6 | 28.2 | Superiority or Other |
| Miettinen and Nurminen | Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity. | 0.449 | Proportion differenece | 4.2 | 2-Sided | 90 | -5.0 | 13.3 | Superiority or Other |
| Miettinen and Nurminen | Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity. | 0.182 | Proportion difference | 7.7 | 2-Sided | 90 | -1.8 | 17.1 | Superiority or Other |
| OG003 | Telcagepant 280 mg | Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine |
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Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine |
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Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine |
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