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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_593 |
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A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Rizatriptan |
|
| 2 | Experimental | Sumatriptan |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rizatriptan benzoate (MK0462) | Drug | single dose 5 mg rizatriptan p.o. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief at 2 Hours After Treatment | Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment | 2 hours after treatment |
| Time to Relief Within 2 Hours After Treatment | Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg). | within 2 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Free at 2 Hours After Treatment | Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain). | 2 hours after treatment |
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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 |
|---|---|---|---|
| 19210513 | Background | Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro RE. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia. 2009 Jul;29(7):711-8. doi: 10.1111/j.1468-2982.2008.01788.x. Epub 2009 Feb 3. | |
| 11422095 | Result | Ferrari MD, Loder E, McCarroll KA, Lines CR. Meta-analysis of rizatriptan efficacy in randomized controlled clinical trials. Cephalalgia. 2001 Mar;21(2):129-36. doi: 10.1046/j.1468-2982.2001.00169.x. |
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Participants screened at a pretreatment visit were given allocated drug supply with instructions. If participants had not treated an attack within 2 months of being enrolled, they were required to return for a rescreen visit. If by 4 months after being enrolled participants still had not treated an attack, they were discontinued from the study.
Participants were recruited at 31 sites: 6 in UK, 9 in Norway, 2 in Switzerland, and 14 in Sweden
First Participant Treated: August 1995
Last Participant Treated: May 1996.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rizatriptan 5 mg | Rizatriptan 5 mg orally once for treatment of single migraine attack |
| FG001 | Sumatriptan 5 mg | Sumatriptan 5 mg orally once for treatment of single migraine attack |
| FG002 | Placebo | Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rizatriptan 5 mg | Rizatriptan 5 mg orally once for treatment of single migraine attack |
| BG001 | Sumatriptan 5 mg | Sumatriptan 5 mg orally once for treatment of 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 | Pain Relief at 2 Hours After Treatment | Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment | An "all-participants-treated" approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after dose. Missing data were replaced by carrying forward the preceding value. | Posted | Number | Participants | 2 hours after treatment |
|
During the 24 hours treatment period, and up to and including 7 days after the last dose of study therapy.
Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.
The At Risk population are the participants that received study treatment.
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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 5 mg | Rizatriptan 5 mg orally once for treatment of single migraine attack |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia/Fatigue | General disorders | CRISP Dictionary | Non-systematic Assessment |
No limitations were encountered in this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
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| 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: sumatriptan | Drug | single dose 50 mg sumatriptan p.o. |
|
| Comparator: Placebo | Drug | Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally |
|
| Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities |
Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest). |
| 2 hours after treatment |
| Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment | Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment. | 2 hours after treatment |
| Participants Who Used Escape Medication 2 Hours After the Treatment Dose | Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication. | 2 hours after treatment |
| Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1]) | Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence | 24 hours |
| 11284464 | Result | Block GA, Goldstein J, Polis A, Reines SA, Smith ME. Efficacy and safety of rizatriptan versus standard care during long-term treatment for migraine. Rizatriptan Multicenter Study Groups. Headache. 1998 Nov-Dec;38(10):764-71. doi: 10.1046/j.1526-4610.1998.3810764.x. |
| Protocol Violation |
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| Withdrawal by Subject |
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| Abnormal Prestudy Labs |
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| Abnormal Baseline ECG |
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| Need for Concom. Med. |
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| Lack of Migraine Attack |
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| No Longer Met Inc/Exc Criteria |
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| Other |
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| Protocol Violation |
|
| Withdrawal by Subject |
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| BG002 | Placebo | Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Baseline Headache Severity | Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain). | Number | Participants |
|
Sumatriptan 5 mg orally once for treatment of single migraine attack
| OG002 | Placebo | Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack |
|
|
| Primary | Time to Relief Within 2 Hours After Treatment | Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg). | An "all-participants-treated" approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication. | Posted | Number | Participants | within 2 hours after treatment |
|
|
|
| Secondary | Pain Free at 2 Hours After Treatment | Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain). | An "all-participants-treated" approach was used in the secondary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication. Missing data were replaced by carrying forward the preceding value. | Posted | Number | Participants | 2 hours after treatment |
|
|
|
| Secondary | Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities | Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest). | An "all-participants-treated" approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value. | Posted | Number | Participants | 2 hours after treatment |
|
|
|
| Secondary | Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment | Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment. | "All-participants-treated" approach was used. Missing data were replaced by carrying forward the preceding value. Participants Analyzed For Nausea: Rizatriptan 348; Sumatriptan 352; Placebo 78. Participants Analyzed for Vomiting: Rizatriptan 342; Sumatriptan 342; Placebo 73. Number of participants analyzed is correct for the other categories. | Posted | Number | Participants | 2 hours after treatment |
|
|
|
| Secondary | Participants Who Used Escape Medication 2 Hours After the Treatment Dose | Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication. | An "all-participants-treated" approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value. | Posted | Number | Participants | 2 hours after treatment |
|
|
|
| Secondary | Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1]) | Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence | The duration of relief, or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1), was calculated for responders who had a headache recurrence. | Posted | Mean | Standard Deviation | Hours | 24 hours |
|
|
|
| 0 |
| 355 |
| 92 |
| 355 |
| EG001 | Sumatriptan 5 mg | Sumatriptan 5 mg orally once for treatment of single migraine attack | 0 | 357 | 108 | 357 |
| EG002 | Placebo | Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack | 0 | 80 | 16 | 80 |
| Fever | General disorders | CRISP Dictionary | Non-systematic Assessment |
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| Pain, Abdominal | General disorders | CRISP Dictionary | Non-systematic Assessment |
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| Pain, Chest | General disorders | CRISP Dictionary | Non-systematic Assessment |
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| Warm Sensation | General disorders | CRISP Dictionary | Non-systematic Assessment |
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| Palpitation | Cardiac disorders | CRISP Dictionary | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | CRISP Dictionary | Non-systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | CRISP Dictionary | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CRISP Dictionary | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CRISP Dictionary | Non-systematic Assessment |
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| Pain, Mouth | Gastrointestinal disorders | CRISP Dictionary | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CRISP Dictionary | Non-systematic Assessment |
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| Heaviness, Regional | Musculoskeletal and connective tissue disorders | CRISP Dictionary | Non-systematic Assessment |
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| Pain, Back | Musculoskeletal and connective tissue disorders | CRISP Dictionary | Non-systematic Assessment |
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| Pain, Neck | Musculoskeletal and connective tissue disorders | CRISP Dictionary | Non-systematic Assessment |
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| Stiffness | Musculoskeletal and connective tissue disorders | CRISP Dictionary | Non-systematic Assessment |
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| Strain | Musculoskeletal and connective tissue disorders | CRISP Dictionary | Non-systematic Assessment |
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| Apathy | Psychiatric disorders | CRISP Dictionary | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
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| Dream Abnormality | Psychiatric disorders | CRISP Dictionary | Non-systematic Assessment |
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| Headache | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
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| Hypesthesia | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
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| Mental Acuity Decreased | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
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| Paresthesia | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
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| Somnolence | Psychiatric disorders | CRISP Dictionary | Non-systematic Assessment |
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| Vertigo | Nervous system disorders | CRISP Dictionary | Non-systematic Assessment |
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| Discomfort, Pharyngeal | Respiratory, thoracic and mediastinal disorders | CRISP Dictionary | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CRISP Dictionary | Non-systematic Assessment |
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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 |
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| Title | Measurements |
|---|---|
|
| Severely Impaired |
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| Required Bed Rest |
|
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| 2-hour Phonophobia |
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| No 2-hour Phonophobia |
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| 2-hour Nausea |
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| No 2-hour Nausea |
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| Not Analyzed for Nausea |
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| 2-hour Vomiting |
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| No 2-hour Vomiting |
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| Not Analyzed for Vomiting |
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|