Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
NCT ID: NCT00604812
Last Updated: 2024-04-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2007-12-17
2010-09-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)
NCT01001234
A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3)
NCT01004263
Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)
NCT00516737
Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-071)
NCT00111709
Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-072)
NCT00111722
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
rizatriptan benzoate (5 mg)
A single dose of rizatriptan 5 mg administered on Day 1.
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.
Rizatriptan 5 mg Placebo
A single dose of rizatriptan 5 mg placebo administered on Day 1.
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.
rizatriptan benzoate (10 mg)
A single dose of rizatriptan 10 mg administered on Day 1.
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.
Rizatriptan 10 mg Placebo
A single dose of rizatriptan 10 mg placebo administered on Day 1.
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.
rizatriptan benzoate (5 mg)
A single dose of rizatriptan 5 mg administered on Day 1.
rizatriptan benzoate (10 mg)
A single dose of rizatriptan 10 mg administered on Day 1.
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.
Rizatriptan 5 mg Placebo
A single dose of rizatriptan 5 mg placebo administered on Day 1.
Rizatriptan 10 mg Placebo
A single dose of rizatriptan 10 mg placebo administered on Day 1.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
rizatriptan benzoate (5 mg)
A single dose of rizatriptan 5 mg administered on Day 1.
rizatriptan benzoate (10 mg)
A single dose of rizatriptan 10 mg administered on Day 1.
Rizatriptan 5 mg Placebo
A single dose of rizatriptan 5 mg placebo administered on Day 1.
Rizatriptan 10 mg Placebo
A single dose of rizatriptan 10 mg placebo administered on Day 1.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Panel C: Male subjects (non-smokers) ages 12 to 17 with a history of migraines
* Subject has a history of migraine headaches, and is not experiencing a migraine on the day of study drug administration
Exclusion Criteria
* Taking medications that are monoamine oxidase inhibitors (MAOI) and selective serotonin reuptake inhibitors (SSRI)
* Subject has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study
6 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Organon and Co
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007_601
Identifier Type: -
Identifier Source: secondary_id
0462-083
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.