Migraine MedDRA version: 14.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. For Panels A and B, the patient is a male or female between the ages of 6 and 17 years. For Panel C, the patient is a male between the ages of 12 and 17 years. 2. Patient has a history of migraine headaches (as defined by the Headache Classification Subcommittee of the International Headache Society [2], and is not experiencing a migraine on the day of study drug administration. 3. Consent: The parent or guardian and patient agrees to the patient’s participation in the study as indicated by parental/guardian signature on the consent form and patient assent. Written assent will be sought from subjects of appropriate intellectual maturity. The patient is willing to comply with procedures, and is able to keep scheduled clinic visits. 4. Patient has a history of migraine (for at least 6 months), but is judged to be otherwise in good health on the basis of medical history and physical examination. 5. Subject is a nonsmoker. 6. If female, subject is not pregnant and not breastfeeding. 7. If female and sexually active, the subject agrees to use a nonhormonal double-barrier birth control device or oral contraception from at least 1 month prior to the start of the study until at least 1 month after the completion of the study. 8. Subject weighs at least 20 kg. Are the trial subjects under 18? yes Number of subjects for this age range: 31 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has no history of migraine headaches, or is experiencing a migraine headache on the day of study drug administration. 2. Subject is 95th percentile for age-appropriate Body Mass Index (see Section 7 Attachments for age-appropriate BMI charts). 3. If female, subject is, pregnant or nursing, or is sexually active but not willing to use effective barrier or appropriate oral contraception during the study. 4. Subject, or parent/legal guardian, is, in the opinion of the investigator, mentally incapacitated. 5. Subject has a history of asthma or other pulmonary disease, major gastrointestinal abnormalities/peptic ulceration, or cardiovascular, hepatic, neurologic, or renal disease. 6. Subject has a history of Kawasaki’s disease. 7. Subject has a history of phenylketonuria. 8. Subject has a history of hemiplegic or basilar migraine. 9. Subject has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering rizatriptan to the subject. 10. Subject has donated a unit of blood, or has participated in another clinical trial with an investigational agent within the 4 weeks prior to study start. 11. Subject drinks excessive amounts of caffeinated coffee or caffeinated beverages (>6 cups/day) at the time of the study. 12. Subject has clinically significant abnormalities on prestudy clinical examination or laboratory measurements, carried out approximately 1 to 2 weeks prior to commencement of the study. 13. Subject is a regular user (including recreational use) of any illicit drugs, or has a history of drug or alcohol abuse. 14. Subject has a history of significant drug allergy or any clinically significant adverse experience (e.g., drug-related rash, urticaria, anaphylaxis) related to the administration of sumatriptan, other triptans or any other marketed or investigational drug. 15. Subject has a history of syncope. 16. Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study. 17. Subject is taking prescription or nonprescription medicines that cannot be discontinued 2 weeks prior to the study day (including herbal remedies such as St. John’s Wort), or is a current user of sumatriptan or other triptan or is a current user of monoamine oxidase (MAO) inhibitors or selective serotonin reuptake inhibitors (SSRIs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of single doses of rizatriptan ODT in pediatric migraineurs ages 6 - 17 years. To obtain preliminary plasma pharmacokinetic data (e.g., AUC, Cmax, Tmax, and terminal t1/2), following single dose administration of rizatriptan ODT in pediatric migraineurs ages 6 - 17 years. ;Secondary Objective: To estimate preliminary plasma pharmacokinetic data following single dose administration of rizatriptan in migraineurs ages 6 - 17 years, and to compare with that obtained historically in adults.;Primary end point(s): Safety and Tolerability;Timepoint(s) of evaluation of this end point: 20, 40, 60, 80, 100 minutes postdose and 2, 3, 4, 6, 8, and 24 hours postdose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): AUC, Cmax, Tmax, and terminal t1/2;Timepoint(s) of evaluation of this end point: 20, 40, 60, 80, 100 minutes postdose and 2, 3, 4, 6, 8, and 24 hours postdose | — |
Countries
United States
Contacts
Public ContactIain Fraser, M.D.
Merck & Co., Inc.
Outcome results
None listed