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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0974-034 | Other Identifier | Merck Protocol Number | |
| 2007_545 | Other Identifier | Telerx ID Number |
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The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg | Experimental | 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). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned. |
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| Placebo and APAP 1000 mg→Telcagepant 300 mg | Experimental | 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). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telcagepant | Drug | Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets) |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1) | 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. | 2 hours post-dose (Up to 6 weeks) |
| Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose | 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. | Within 14 days of any dose of study medication (Up to 16 weeks) |
| Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose | 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. | Up to 48 hours post-dose (Up to 14 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22221076 | Derived | Ho TW, Ho AP, Chaitman BR, Johnson C, Mathew NT, Kost J, Fan X, Aurora SK, Brandes JL, Fei K, Beebe L, Lines C, Krucoff MW. Randomized, controlled study of telcagepant in patients with migraine and coronary artery disease. Headache. 2012 Feb;52(2):224-35. doi: 10.1111/j.1526-4610.2011.02052.x. Epub 2012 Jan 6. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (6 Weeks) |
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| Acetaminophen/Paracetamol | Drug | Acetaminophen/Paracetamol (500 mg X 2 dosage units) |
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| Placebo to Telcagepant | Drug | Placebo 300 mg soft gel capsules or placebo 280 mg tablet. |
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| Placebo to Acetaminophen/Paracetamol | Drug | Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units) |
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| 2 hours post-dose (Up to 6 weeks) |
| Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose | Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events. | Up to 48 hours after the dose of any study medication (Up to 14 weeks) |
| Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1) | The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points. | 2 hours post-dose (Up to 6 weeks) |
| Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1) | The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points. | 2 Hours post-dose (Up to 6 weeks) |
| Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1) | The participant recorded whether nausea was present or absent at each of the predefined time points. | 2 hours post-dose (Up to 6 weeks) |
| Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose | 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. | Up to 24 hours post-dose (Up to 14 weeks) |
| FG001 | 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). |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Wash-Out (14 Days) |
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| Period 2 (6 Weeks) |
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All treated participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Telcagepant 300 mg→APAP 1000 mg | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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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 2 Hours Post-dose (Period 1, Migraine Attack 1) | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 2 hours post-dose (Up to 6 weeks) |
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| Secondary | Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1) | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 2 hours post-dose (Up to 6 weeks) |
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| Primary | Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose | 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. | 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. | Posted | Number | Participants | Within 14 days of any dose of study medication (Up to 16 weeks) |
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| Primary | Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose | 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. | 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. | Posted | Number | Participants | Up to 48 hours post-dose (Up to 14 weeks) |
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| Secondary | Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose | Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events. | 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. | Posted | Number | Participants | Up to 48 hours after the dose of any study medication (Up to 14 weeks) |
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| Secondary | Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1) | The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 2 hours post-dose (Up to 6 weeks) |
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| Secondary | Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1) | The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 2 Hours post-dose (Up to 6 weeks) |
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| Secondary | Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1) | The participant recorded whether nausea was present or absent at each of the predefined time points. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 2 hours post-dose (Up to 6 weeks) |
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| Secondary | Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 24 hours post-dose (Up to 14 weeks) |
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Up to 48 hours post-dose (Up to 14 weeks)
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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 | Telcagepant | Participants receiving telcagepant | 1 | 98 | 0 | 98 | ||
| EG001 | Acetaminophen/Paracetamol | Participants receiving acetaminophen/paracetamol | 0 | 86 | 0 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Psychotic disorder | Psychiatric disorders | MedDRA 12.0 | 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 |
| D006331 | Heart Diseases |
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| D014652 | Vascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D002545 | Brain Ischemia |
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| ID | Term |
|---|---|
| C525458 | telcagepant |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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