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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_680 |
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To provide long term safety data for rizatriptan in children and adolescents. The primary hypothesis of the study is that rizatriptan is well tolerated in the long term treatment of acute migraine in pediatric patients age 12-17 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rizatriptan | Experimental | Rizatriptan benzoate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rizatriptan benzoate | Drug | Single dose of 5 mg or 10 mg orally disintegrating tablet at onset of migraine attack |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. Participants with an AE occurring within 24 hours after any dose administered during the study are counted once in this summary. | Up to 24 hours post dose |
| Number of Participants With AEs Within 14 Days Post Any Dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. AEs were assessed in a phone contact 14 days after the last dose of study medication. Participants with an AE occurring within 14 days after any dose administered during the study are counted once in this summary. | Up to 14 days post dose |
| Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 24 hours post dose are counted in this summary. | Up to 24 hours post dose |
| Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 14 days post dose are counted in this summary. | Up to 14 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom (PF) was defined as a reduction in severity from a rating of 5, 4, 3 or 2 (mild, moderate or severe pain) before the dose to a rating of 1 (no pain) at 2 hours after dosing. Pain intensity ratings were reported in diaries returned at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. PF at 2 hours was summarized as follows: the percentage of treated attacks with PF at 2 hours was calculated for each patient first, then the mean across all patients was calculated. |
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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 |
|---|---|---|---|
| 23078588 | Derived | Hewitt DJ, Pearlman E, Hamalainen M, Lewis D, Connor KM, Michelson D, Ceesay P, Assaid C, Bachman R, Harper Mozley L, Dupre N, Strickler N, Mahoney E, Lines C, Ho TW. Long-term open-label safety study of rizatriptan acute treatment in pediatric migraineurs. Headache. 2013 Jan;53(1):104-117. doi: 10.1111/j.1526-4610.2012.02285.x. Epub 2012 Oct 18. |
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A total of 674 patients met inclusion/exclusion criteria and were allocated study drug. Of these, 606 were treated with study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rizatriptan | Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 2 hours post dose |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rizatriptan | Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 With Adverse Events (AEs) Within 24 Hours Post Any Dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. Participants with an AE occurring within 24 hours after any dose administered during the study are counted once in this summary. | All enrolled participants who administered at least one dose of study medication | Posted | Number | participants | Up to 24 hours post dose |
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| Primary | Number of Participants With AEs Within 14 Days Post Any Dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. AEs were assessed in a phone contact 14 days after the last dose of study medication. Participants with an AE occurring within 14 days after any dose administered during the study are counted once in this summary. | All enrolled participants who administered at least one dose of study medication | Posted | Number | participants | Up to 14 days post dose |
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| Secondary | Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom (PF) was defined as a reduction in severity from a rating of 5, 4, 3 or 2 (mild, moderate or severe pain) before the dose to a rating of 1 (no pain) at 2 hours after dosing. Pain intensity ratings were reported in diaries returned at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. PF at 2 hours was summarized as follows: the percentage of treated attacks with PF at 2 hours was calculated for each patient first, then the mean across all patients was calculated. | All participants who were enrolled and reported at least one treated migraine attack with at least one post treatment efficacy evaluation | Posted | Mean | Standard Deviation | percentage of participant's attacks | 2 hours post dose |
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| Primary | Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 24 hours post dose are counted in this summary. | All enrolled participants who administered at least one dose of study medication | Posted | Number | participants | Up to 24 hours post dose |
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| Primary | Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 14 days post dose are counted in this summary. | All enrolled participants who administered at least one dose of study medication | Posted | Number | participants | Up to 14 days post dose |
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Up to 12 months after start of study drug administration
AE tables include all enrolled participants who administered at least one dose of study medication
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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 self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg). | 22 | 606 | 284 | 606 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus bradycardia | Cardiac disorders | MedDRA 13.1 |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 |
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| Fatigue | General disorders | MedDRA 13.1 |
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| Appendicitis | Infections and infestations | MedDRA 13.1 |
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| Gastroenteritis | Infections and infestations | MedDRA 13.1 |
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| Viral infection | Infections and infestations | MedDRA 13.1 |
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| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Migraine | Nervous system disorders | MedDRA 13.1 |
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| Syncope | Nervous system disorders | MedDRA 13.1 |
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| Conversion disorder | Psychiatric disorders | MedDRA 13.1 |
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| Major depression | Psychiatric disorders | MedDRA 13.1 |
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| Suicidal ideation | Psychiatric disorders | MedDRA 13.1 |
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| Suicide attempt | Psychiatric disorders | MedDRA 13.1 |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
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| Peripheral ischemia | Vascular disorders | MedDRA 13.1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 |
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| Fatigue | General disorders | MedDRA 13.1 |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.1 |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 13.1 |
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| Dizziness | Nervous system disorders | MedDRA 13.1 |
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| Somnolence | Nervous system disorders | MedDRA 13.1 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| C093622 | rizatriptan |
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