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: Consent a. The parent or guardian and subject agrees to the subject’s participation in the study as indicated by parental/guardian signature on the consent form and subject assent. Written assent will be sought from subjects of appropriate intellectual maturity. The subject is willing to comply with procedures, and is able to keep scheduled clinic visits. Demographics b. The subject is a male or female between the ages of 6 and 11 years of age (inclusive) on the day of screening. c. Female subjects of reproductive potential (or other female subjects at the discretion of the investigator) must demonstrate a serum ß-hCG level consistent with the nongravid state at the prestudy (screening) visit and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the prestudy visit throughout the study and until 2 weeks after the dose of study. Acceptable methods of birth control are two (2) of the following: intrauterine device (IUD-with or without local hormone release), diaphragm, spermicides, cervical cap, contraceptive sponge, and /or condoms. Abstinence is an alternative life style and subjects practicing abstinence may be included in the study. d. The subject weighs at least 20 kg. Medical history, physical examinations, laboratory safety tests and ECG measurements e. Subject has a history of migraine (as defined by the Headache Classification Subcommittee of the International Headache Society [1]), for at least 6 months, but is judged to be otherwise in good health based on the basis of medical history, physical examination, vital sign measurements, and laboratory safety tests (see Appendix 6.1 and 6.2) performed at the prestudy (screening) visit and/or prior to administration of study drug. f. Subject has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening). g. Subject is not a nursing mother. Diet/Activity/Other h. Subject is a nonsmoker. i. Subject is willing to comply with the study restrictions (see Section 3.2. for a complete summary of study restrictions). Are the trial subjects under 18? yes Number of subjects for this age range: 12 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: a. Subject or parent/legal guardian, is, in the opinion of the investigator, mentally incapacitated. b. Subject has no history of migraine headaches, or is experiencing a migraine headache on the day of study drug administration. c. Subject is 95th percentile for age-appropriate Body Mass Index (see Appendix 6.5 and 6.6 for age-appropriate BMI charts for males and females). d. Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 2 years. Subjects who have had situational depression may be enrolled in the study at the discretion of the investigator. e. Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. Subjects with a history of uncomplicated kidney stones or childhood asthma may be enrolled in the study at the discretion of the investigator. f. Subject has a history of Kawasaki’s disease. g. Subject has a history of phenylketonuria. h. Subject has a history of hemiplegic or basilar migraine. i. Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study and in administering Maxalt-MLT® to the subject. j. Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 mL), or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit. The 4 week window will be derived from the date of the last study procedure (i.e. poststudy, AE follow-up, etc.) in the previous study to the prestudy/screening visit of the current study k. Subject consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day.. l. Subject has clinically significant abnormalities on prestudy clinical examination or laboratory measurements. m. Subject is a regular user (including "recreational use") of any illicit drugs, or has a history of drug or alcohol abuse. n. 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. o. Subject has a history of syncope. p. Subject has a history of taste or olfactory impairment. q. Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study. r. 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). s. Subject has a history of stroke, chronic seizures, or major neurological disorder (other than history of migraines). t. Subject has a history of neoplastic disease. u. There is any concern by the investigator regarding the safe participation of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the palatability of Maxalt-MLT® ODT in pediatric migraineurs, ages 6 - 11 years. ;Secondary Objective: To assess the safety and tolerability of single doses of Maxalt-MLT® ODT in pediatric migraineurs, ages 6 - 11 years.;Primary end point(s): Palatability Assessment;Timepoint(s) of evaluation of this end point: 5 minutes postdose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability;Timepoint(s) of evaluation of this end point: Screening, predose, poststudy | — |
Countries
United States
Contacts
Public ContactMatt S. Anderson, Ph.D.
Merck & Co., Inc.
Outcome results
None listed