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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_082 |
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The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. |
|
| MK0974 25 mg | Experimental | MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
|
| MK0974 50 mg | Experimental | MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
|
| MK0974 100 mg | Experimental | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
|
| MK0974 200 mg | Experimental | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Placebo | Drug | Placebo to match assigned treatment arm; one orally-administered dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief at 2 Hours | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack. | 2 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Freedom at 2 Hours | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose. | 2 hours post dose |
| Sustained Pain Relief |
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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 |
|---|---|---|---|
| 17914062 | Background | Ho TW, Mannix LK, Fan X, Assaid C, Furtek C, Jones CJ, Lines CR, Rapoport AM; MK-0974 Protocol 004 study group. Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology. 2008 Apr 15;70(16):1304-12. doi: 10.1212/01.WNL.0000286940.29755.61. Epub 2007 Oct 3. |
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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.
20 centers from the United States participated. First Patient treated on 01 December 2005; Last Patient Last Treatment was on 01 May 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. |
| FG001 | MK0974 25 mg | MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| FG002 | MK0974 50 mg | MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| FG003 | MK0974 100 mg | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| FG004 | MK0974 200 mg | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| FG005 | MK0974 300 mg | MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| FG006 | MK0974 400 mg | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| FG007 | MK0974 600 mg | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| FG008 | Rizatriptan 10 mg | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pain Relief at 2 Hours | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack. | All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing. | Posted | Number | Participants | 2 hours post dose |
|
Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
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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 | Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Late Stage Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@spcorp.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 |
| C093622 | rizatriptan |
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| MK0974 300 mg | Experimental | MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
|
| MK0974 400 mg | Experimental | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
|
| MK0974 600 mg | Experimental | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
|
| Rizatriptan 10 mg | Active Comparator | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
|
| MK0974 |
| Drug |
MK0974 25 mg; one orally-administered dose |
|
| MK0974 | Drug | MK0974 50 mg; one orally-administered dose |
|
| MK0974 | Drug | MK0974 100 mg; one orally-administered dose |
|
| MK0974 | Drug | MK0974 200 mg; one orally-administered dose |
|
| MK0974 | Drug | MK0974 300 mg; one orally-administered dose |
|
| MK0974 | Drug | MK0974 400 mg; one orally-administered dose |
|
| MK0974 | Drug | MK0974 600 mg; one orally-administered dose |
|
| Rizatriptan | Drug | Rizatriptan 10 mg; one orally-administered dose |
|
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose. |
| 2-24 hours post dose |
| Sustained Pain Freedom | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose. | 2-24 hours post dose |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lack of Qualifying Event |
|
| Site Terminated |
|
| Abnormal baseline lab values |
|
| Overwhelmed |
|
| Protocol Violator |
|
| Reported as completing trial in error |
|
| MK0974 25 mg |
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG002 | MK0974 50 mg | MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG003 | MK0974 100 mg | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG004 | MK0974 200 mg | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG005 | MK0974 300 mg | MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG006 | MK0974 400 mg | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG007 | MK0974 600 mg | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG008 | Rizatriptan 10 mg | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. |
| BG009 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Baseline Severity | Baseline severity was self-reported by the participant and recorded in the take-home diary. Migraine pain was rated on a 4-point scale (No Pain=0, Mild Pain=1, Moderate Pain=2, Severe Pain=3). | Number | Participants |
|
| OG001 | MK0974 25 mg | MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| OG002 | MK0974 50 mg | MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| OG003 | MK0974 100 mg | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| OG004 | MK0974 200 mg | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| OG005 | MK0974 300 mg | MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| OG006 | MK0974 400 mg | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| OG007 | MK0974 600 mg | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| OG008 | Rizatriptan 10 mg | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
|
|
|
| Secondary | Pain Freedom at 2 Hours | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose. | All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing. | Posted | Number | Participants | 2 hours post dose |
|
|
|
|
| Secondary | Sustained Pain Relief | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose. | All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing | Posted | Number | Participants | 2-24 hours post dose |
|
|
|
|
| Secondary | Sustained Pain Freedom | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose. | All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing. | Posted | Number | Participants | 2-24 hours post dose |
|
|
|
|
| 1 |
| 47 |
| 10 |
| 47 |
| EG001 | MK0974 25 mg | MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | 0 | 17 | 4 | 17 |
| EG002 | MK0974 50 mg | MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | 0 | 19 | 9 | 19 |
| EG003 | MK0974 100 mg | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | 0 | 27 | 4 | 27 |
| EG004 | MK0974 200 mg | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | 0 | 18 | 7 | 18 |
| EG005 | MK0974 300 mg | MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | 0 | 51 | 9 | 51 |
| EG006 | MK0974 400 mg | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | 0 | 52 | 12 | 52 |
| EG007 | MK0974 600 mg | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | 0 | 49 | 14 | 49 |
| EG008 | Rizatriptan 10 mg | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | 0 | 50 | 10 | 50 |
| Tinnitus | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| Food craving | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Bruxism | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | 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 |