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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_547 |
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The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Active Drug |
|
| 2 | Placebo Comparator | Matching Pbo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: rizatriptan benzoate | Drug | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Are Pain Free at 2 Hours Post-Dose | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose. | 2 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 24-Hour Sustained Pain Freedom | 24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary. | 24 hours post-dose |
| Number of Participants With no Rescue Use up to 24 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 |
|---|---|---|---|
| 19472447 | Background | Cady RK, Martin VT, Geraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. doi: 10.1111/j.1526-4610.2009.01412.x. |
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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.
Phase III First Patient In: 03-October-2007 Last Patient Last Visit: 08-April-2008 13 outpatient centers worldwide (10 United States, 3 Germany)
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| ID | Title | Description |
|---|---|---|
| FG000 | Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| FG001 | Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| BG001 | Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| 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 | Number of Participants Who Are Pain Free at 2 Hours Post-Dose | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose. | Full Analysis Set (FAS): The FAS population includes all randomized participants who have at least one assessment within 2 hours post-dose (i.e., after baseline assessment). | Posted | Number | Participants | 2 hours post-dose |
|
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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 | Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
In the Adverse Events section, all non-serious adverse experiences reported are post-treatment, up to the time of taking rescue medication or 14 days post-dose, whichever comes first.
| 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 |
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| ID | Term |
|---|---|
| C093622 | rizatriptan |
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| Comparator: Placebo | Drug | Matching placebo; one dose, treatment of a single migraine attack |
|
Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary. |
| 24 hours post-dose |
| Number of Participants With Absence of Photophobia at 2 Hours Post-dose | Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose. | 2 hours post-dose |
| Number of Participants With Absence of Phonophobia at 2 Hours Post-dose | Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose. | 2 hours post-dose |
| Number of Participants With Absence of Nausea at 2 Hours Post-dose | Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose. | 2 hours post-dose |
| Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose | Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose. | 2 hours post-dose |
| Withdrawal by Subject |
|
| Lack of Qualifying Event |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Matching placebo; one dose, treatment of a single migraine attack
|
|
| Secondary | Number of Participants With 24-Hour Sustained Pain Freedom | 24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary. | The FAS population was used for this secondary variable of 24-hour sustained pain freedom, unless participants were otherwise identified as non-responders for this endpoint (i.e., took rescue up to 24 hours post-dose or were not pain free at 2 hours post-dose). To be included, participants must have also had a non-missing 24-hour assessment. | Posted | Number | Participants | 24 hours post-dose |
|
|
|
| Secondary | Number of Participants With no Rescue Use up to 24 Hours Post-Dose | Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary. | The FAS population included all randomized and treated participants. | Posted | Number | Participants | 24 hours post-dose |
|
|
|
| Secondary | Number of Participants With Absence of Photophobia at 2 Hours Post-dose | Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose. | The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment). | Posted | Number | Participants | 2 hours post-dose |
|
|
|
| Secondary | Number of Participants With Absence of Phonophobia at 2 Hours Post-dose | Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose. | The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment). | Posted | Number | Participants | 2 hours post-dose |
|
|
|
| Secondary | Number of Participants With Absence of Nausea at 2 Hours Post-dose | Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose. | The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment). | Posted | Number | Participants | 2 hours post-dose |
|
|
|
| Secondary | Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose | Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose. | The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment). | Posted | Number | Participants | 2 hours post-dose |
|
|
|
| 0 |
| 92 |
| 6 |
| 92 |
| EG001 | Placebo | Matching placebo; one dose, treatment of a single migraine attack | 0 | 96 | 3 | 96 |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA | Non-systematic Assessment |
|
| Feeling jittery | General disorders | MedDRA | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA | 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 |