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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_526 |
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The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK0974 50 mg | Experimental | MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack |
|
| MK0974 150 mg | Experimental | MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack |
|
| MK0974 300 mg | Experimental | MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack |
|
| Placebo | Placebo Comparator | Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0974 50 mg | Drug |
|
| |
| MK0974 150 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reporting Pain Freedom at 2 Hours Postdose | Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain. | 2 hours post dose |
| Number of Patients Reporting Pain Relief at 2 Hours Post Dose | Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain. | 2 hours post dose |
| Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose | Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary. | 2 hours post dose |
| Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose | Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary. | 2 hours post dose |
| Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose | Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary. | 2 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose | Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication. | 2 to 24 hours postdose |
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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 |
|---|---|---|---|
| 19770473 | Result | Connor KM, Shapiro RE, Diener HC, Lucas S, Kost J, Fan X, Fei K, Assaid C, Lines C, Ho TW. Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology. 2009 Sep 22;73(12):970-7. doi: 10.1212/WNL.0b013e3181b87942. |
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Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit.
There were 83 centers worldwide that participated: United States (36), Latin America (9), and Europe (38). First Patient Treated = 25 March 2007, and Last Patient Last Treatment = 29 November 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK0974 50 mg | MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack |
| FG001 | MK0974 150 mg | MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack |
| FG002 | MK0974 300 mg | MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack |
| FG003 | Placebo | Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK0974 50 mg | MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG001 | MK0974 150 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline Characteristics are for the subset of randomized patients who were treated |
| 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 | Number of Patients Reporting Pain Freedom at 2 Hours Postdose | Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain. | All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours. | Posted | Number | Participants | 2 hours post dose |
|
Adverse events were recorded from the time that the patient was first treated with study therapy through 14 days following the last dose of study therapy.
Subjective adverse experiences were recorded by the patient in a paper diary.
Patients were counted in the treatment group for which they actually took study drug. One patient gave some of their study drug to another patient; resulting in the difference in 2 groups of 1 from what was reported in the Participant Flow "Completed--With Data".
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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 | MK0974 50 mg | MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Traumatic Brain Injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialDisclosure@merck.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C525458 | telcagepant |
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| Drug |
|
|
| MK0974 300 mg | Drug |
|
|
| Comparator: Placebo | Drug | MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo. |
|
| Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose |
Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication. |
| 2 to 24 hours postdose |
| Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose | Pain Freedom and no migraine-associated symptoms at 2 hours postdose. | 2 hours postdose |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lack of Qualifying Event |
|
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG002 | MK0974 300 mg | MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG003 | Placebo | Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Baseline Characteristics are for the subset of randomized patients who were treated | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Baseline Characteristics are for the subset of randomized patients who were treated | Number | participants |
|
| Baseline Severity | Baseline severity was self-reported by the patient and recorded in the take-home diary. Patients were instructed not to dose until they had experienced either a moderate or severe migraine, with migraine pain rated on a 4-point scale (No Pain=0, Mild Pain=1, Moderate Pain=2, Severe Pain=3). Baseline Characteristics are for the subset of randomized patients who were treated. | Number | Participants |
|
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
| OG002 | MK0974 300 mg | MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack |
| OG003 | Placebo | Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack |
|
|
|
| Secondary | Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose | Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication. | All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain) | Posted | Number | Participants | 2 to 24 hours postdose |
|
|
|
|
| Primary | Number of Patients Reporting Pain Relief at 2 Hours Post Dose | Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain. | All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours. | Posted | Number | Participants | 2 hours post dose |
|
|
|
|
| Primary | Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose | Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary. | All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours. | Posted | Number | Participants | 2 hours post dose |
|
|
|
|
| Primary | Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose | Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary. | All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours. | Posted | Number | Participants | 2 hours post dose |
|
|
|
|
| Primary | Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose | Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary. | All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours. | Posted | Number | Participants | 2 hours post dose |
|
|
|
|
| Secondary | Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose | Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication. | All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain) | Posted | Number | Participants | 2 to 24 hours postdose |
|
|
|
|
| Secondary | Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose | Pain Freedom and no migraine-associated symptoms at 2 hours postdose. | All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours. | Posted | Number | Participants | 2 hours postdose |
|
|
|
|
| 0 |
| 177 |
| 45 |
| 177 |
| EG001 | MK0974 150 mg | MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack | 1 | 381 | 69 | 381 |
| EG002 | MK0974 300 mg | MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack | 0 | 370 | 94 | 370 |
| EG003 | Placebo | Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack | 1 | 366 | 77 | 366 |
| Hypertension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D009422 | Nervous System Diseases |
P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous). |
| <0.001 |
| 95 |
| No |
| Superiority or Other |
P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous). |
| <0.001 |
| 95 |
| No |
| Superiority or Other |
P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous). |
| <0.001 |
| 95 |
| No |
| Superiority or Other |
P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous). |
| <0.001 |
| 95 |
| No |
| Superiority or Other |
P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous). |
| <0.001 |
| 95 |
| No |
| Superiority or Other |
P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous). |
| <0.001 |
| 95 |
| No |
| Superiority or Other |
P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous). |
| <0.001 |
| 95 |
| No |
| Superiority or Other |