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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_679 | Other Identifier | Merck Registration Number | |
| CTRI/2010/091/000407 | Other Identifier | CTRI |
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This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1: rizatriptan | Experimental |
| |
| Stage 1: placebo | Placebo Comparator |
| |
| Stage 2: rizatriptan | Experimental |
| |
| Stage 2: placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rizatriptan | Drug | For participants randomized to rizatriptan in Stage 1: a single 5 or 10 mg rizatriptan orally disintegrating tablet (ODT) was to be taken within 30 minutes of onset of qualifying migraine (defined as a migraine of moderate or severe intensity). Rizatriptan dose administered was based on participant weight at Screening: those <40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available. | 2 hours post Stage 2 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available. |
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Inclusion Criteria:
patient assent
- For patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1.
Exclusion Criteria:
headache on more than 10 days per month in any of the 3 months prior to screening
cancer, or any other significant disease
adverse event in response to rizatriptan
investigational compound or device within 30 days of screening
- Patient is legally or mentally incapacitated.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22711898 | Derived | Ho TW, Pearlman E, Lewis D, Hamalainen M, Connor K, Michelson D, Zhang Y, Assaid C, Mozley LH, Strickler N, Bachman R, Mahoney E, Lines C, Hewitt DJ; Rizatriptan Protocol 082 Pediatric Migraine Study Group. Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. Cephalalgia. 2012 Jul;32(10):750-65. doi: 10.1177/0333102412451358. Epub 2012 Jun 18. |
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Participants randomized to double-blind study medication (Stage 1 - placebo or rizatriptan in a 20:1 ratio) at the Screening visit were given study drug and administration instructions. If a participant had not treated a qualifying migraine attack within up to 2-4 months, he/she may have been discontinued from the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/NA | Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered. |
| FG001 | Rizatriptan/NA | Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered. |
| FG002 | Placebo/Rizatriptan | Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single rizatriptan 5 or 10 mg oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo. |
| FG003 | Placebo/Placebo | Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single placebo oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo. |
| FG004 | Rizatriptan/Placebo | Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), allocated to receive single placebo oral tablet in Stage 2 to treat same qualifying migraine treated in Stage 1 (Stage 2 dose to be administered 15 minutes post Stage 1 dose). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/NA | Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Includes only participants who took study drug |
| 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 Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available. | Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded. | Posted | Number | participants | 2 hours post Stage 2 dose |
|
Up to 14 days post dose
Includes all randomized participants who received at least one dose of study drug (i.e., participants who only took study drug in Stage 1 were also included). Participants were included in the treatment group corresponding to the study treatment they actually received, with active treatment taking precedence over placebo 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 | Participants who took any rizatriptan during the study (Stage 1 or 2) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enterobacter bacteremia | Infections and infestations | MedDRA 13.1 |
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| 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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|
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| placebo | Drug | For participants randomized to placebo in Stage 1: a single placebo ODT was to be taken within 30 minutes of onset of qualifying migraine. |
|
| rizatriptan | Drug | For participants randomized to rizatriptan in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder [moderate or severe pain 15 minutes after dose] to be randomized at Stage 2): a single 5 or 10 mg rizatriptan ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Rizatriptan dose administered was based on participant weight at Screening: those <40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet. |
|
|
| placebo | Drug | For participants randomized to placebo in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder to be randomized at Stage 2) or allocated to placebo in Stage 2 (took rizatriptan in Stage 1 and was Non-Responder): a single placebo ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. |
|
| 2 hours post Stage 2 dose |
| Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available. | 2 hours post Stage 2 dose |
| Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available. | 2 hours post Stage 2 dose |
| Protocol Violation |
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| Lost to Follow-up |
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| Physician Decision |
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| Not Treated: Adverse Event |
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| Not Treated: Withdrawal by Subject |
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| Not Treated: Protocol Violation |
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| Not Treated: Lost to Follow-up |
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| Not Treated: Pregnancy |
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| Not Treated: Physician Decision |
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| Not Treated: Lack of Qualifying Event |
|
| Rizatriptan/NA |
Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered. |
| BG002 | Placebo/Rizatriptan | Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single rizatriptan 5 or 10 mg oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo. |
| BG003 | Placebo/Placebo | Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single placebo oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo. |
| BG004 | Rizatriptan/Placebo | Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), allocated to receive single placebo oral tablet in Stage 2 to treat same qualifying migraine treated in Stage 1 (Stage 2 dose to be administered 15 minutes post Stage 1 dose). |
| BG005 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Includes only participants who took study drug | Count of Participants | Participants |
|
| Rizatriptan |
Participants randomized to rizatriptan in Stage 2 |
| OG001 | Placebo | Participants randomized to placebo in Stage 2 |
|
|
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| Secondary | Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available. | Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded. | Posted | Number | participants | 2 hours post Stage 2 dose |
|
|
|
|
| Secondary | Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available. | Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded. | Posted | Number | participants | 2 hours post Stage 2 dose |
|
|
|
|
| Secondary | Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available. | Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded. | Posted | Number | participants | 2 hours post Stage 2 dose |
|
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|
|
| 0 |
| 462 |
| 0 |
| 462 |
| EG001 | Placebo | Participants who took only placebo during the study | 2 | 515 | 0 | 515 |
| Migraine | Nervous system disorders | MedDRA 13.1 |
|
Investigator agrees to delay publication of study results until Food and Drug Administration (FDA) grants pediatric exclusivity on the study drug. Investigator may publish results for his/her study site after primary publication of results of entire multicenter trial. Sponsor must be able to review all proposed results communications regarding study 60 days prior to submission for publication/presentation. Information identified by the Sponsor as confidential must be deleted prior to submission.
| D009422 | Nervous System Diseases |
| Superiority or Other (legacy) |
| Superiority or Other (legacy) |
| Superiority or Other (legacy) |