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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_601 |
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A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines.
After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. Therefore, the study was amended to add an additional panel of subjects (Panel C) to ensure gender balance specifically in this age group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A Rizatriptan | Experimental | Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 20-39 kg were allocated to Panel A. |
|
| Panel A Placebo | Placebo Comparator | Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 20-39 kg were allocated to Panel A. |
|
| Panel B Rizatriptan | Experimental | Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 40 kg and above were allocated to Panel B. |
|
| Panel B Placebo | Placebo Comparator | Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 40 kg and above were allocated to Panel B. |
|
| Panel C Rizatriptan | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rizatriptan benzoate (5 mg) | Drug | A single dose of rizatriptan 5 mg administered on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs | All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis) | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞)) | Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot | 24 Hours |
| Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22289113 | Derived | Fraser IP, Han L, Han TH, Li CC, Hreniuk D, Stoch SA, Wagner JA, Linder S, Winner P. Pharmacokinetics and tolerability of rizatriptan in pediatric migraineurs in a randomized study. Headache. 2012 Apr;52(4):625-35. doi: 10.1111/j.1526-4610.2011.02069.x. Epub 2012 Jan 30. |
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Panel C was added to the study by amendment after enrollment of Panels A and B were completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panel A Rizatriptan | Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 20-39 kg were allocated to Panel A. |
| FG001 | Panel A Placebo | Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 20-39 kg were allocated to Panel A. |
| FG002 | Panel B Rizatriptan | Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 40 kg and above were allocated to Panel B. |
| FG003 | Panel B Placebo | Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 40 kg and above were allocated to Panel B. |
| FG004 | Panel C Rizatriptan | Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group. |
| FG005 | Panel C Placebo | Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Panel A | Includes the participants from the 5 mg rizatriptan group (9) and the matching placebo group (3) |
| BG001 | Panel B | Includes the participants from the 10 mg rizatriptan group (10) and the matching placebo group (3) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs | All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis) | All Subjects as Treated- All subjects who received at least one dose of the investigational drug was used for assessments of safety and tolerability. | Posted | Number | Participants | 24 Hours |
|
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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 | Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
Pharmacokinetic data presented are preliminary data.
| 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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Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.
Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.
|
| Panel C Placebo | Placebo Comparator | Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group. |
|
| rizatriptan benzoate (10 mg) | Drug | A single dose of rizatriptan 10 mg administered on Day 1. |
|
|
| Rizatriptan 5 mg Placebo | Drug | A single dose of rizatriptan 5 mg placebo administered on Day 1. |
|
| Rizatriptan 10 mg Placebo | Drug | A single dose of rizatriptan 10 mg placebo administered on Day 1. |
|
Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved |
| 24 Hours |
| Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax) | Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration | 24 Hours |
| Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½) | Preliminary pharmacokinetics data; Apparent half-life (t½) | 24 Hours |
| BG002 | Panel C | Includes the participants who received 5 mg rizatriptan (n=1), 10 mg rizatriptan (n=4), and the matching placebo (n=1) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Number | participants |
|
Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1. |
| OG002 | Placebo | Combined Placebo groups from panels A, B, and C. |
|
|
| Secondary | Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞)) | Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot | Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations. | Posted | Mean | Standard Deviation | ng hr/mL | 24 Hours |
|
|
|
| Secondary | Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax) | Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved | Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations. | Posted | Mean | Standard Deviation | ng/mL | 24 Hours |
|
|
|
| Secondary | Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax) | Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration | Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations. | Posted | Median | Full Range | Hours | 24 Hours |
|
|
|
| Secondary | Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½) | Preliminary pharmacokinetics data; Apparent half-life (t½) | Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations. | Posted | Mean | Standard Deviation | Hours | 24 Hours |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Rizatriptan 10 mg | Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1. | 0 | 14 | 7 | 14 |
| EG002 | Placebo | Combined Placebo groups from panels A, B, and C. | 0 | 7 | 3 | 7 |
| Bruising of arm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | Systematic Assessment |
|
| Earache | Ear and labyrinth disorders | Systematic Assessment |
|
| Visual disturbance | Eye disorders | Systematic Assessment |
|
| Injection site pain | General disorders | Systematic Assessment |
|
| Tiredenss | General disorders | Systematic Assessment |
|
| Cold | Infections and infestations | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Painful left arm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Elevation in blood pressure | Vascular disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | 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 |