How do I alleviate my misophony
Treximet Early Intervention Adolescent Migraines
1. Male or female subjects between 12 and 17 years of age.
2. The subject has migraines with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history of at least 1 but no more than 8 attacks per month in the 6 months prior to the screening visit. Attacks should be moderate to severe and last at least 3 years.
3. The subject can distinguish migraines from other headaches and determine when a mild headache becomes a moderate / severe migraine.
4. Female subjects are eligible to participate, provided they are not of childbearing potential or when menstruation has started; You are on a stable regimen of approved contraception.
5. The subject and the subject's parent or guardian can read and write English.
6. The subject can read, understand and complete technical journals.
7. The subjects' parents or legal guardians are willing and able to give informed consent prior to the subject's entry into the study.
8. The subject is ready and able to give informed consent before entering the study.
Subjects who meet any of the following criteria may not be included in the study:
1. The subject is <33.3 kg (74 pounds) and no greater than 117.9 kg (260 pounds).
2. The subject has a total of at least 15 headache days per month.
3. The subject has secondary headache; H. Complex migraines, hemiplegia, or basilar.
4. In the opinion of the investigators, it is likely that the opinion of the cardiovascular system has not been recognized or cerebrovascular disease.
5. The subject has uncontrolled hypertension at screening or is taking an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
6. The subject has a history of congenital heart disease requiring cardiac arrhythmia, or a history of a clinically significant electrocardiogram abnormality. The investigator believes this is contraindicated for participation in the study.
7. The subject has evidence or a history of ischemic vascular disease including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease, or signs / symptoms consistent with the above.
8. The subject has signs or a history of central nervous system pathology, including stroke and / or transient ischemic attacks (TIAs), epilepsy, or structural brain lesions that lower the seizure threshold, or has been treated with an anti-epileptic drug for seizure control within 5 years prior to screening .
9. The subject has a history of impaired liver or kidney function, which in the opinion of the investigator contraindicated participation in this study.
10. The subject has a hypersensitivity, allergy, intolerance, or contraindication to use of triptan, NSAID, or aspirin (including all sumatriptan and naproxen supplements), or has nasal polyps or asthma.
11. The subject has used an ergot drug for migraine prophylaxis in the past three months or is taking a drug that has not been stabilized for at least two months for chronic or intermittent migraine prophylaxis or other comorbid conditions.
12. The subject has a monoamine oxidase inhibitor (MAOI) including, or scheduled, including herbal preparations containing St. John's wort (Hypericum perforatum) at any time within the two weeks prior to screening and two weeks after the end of the study.
13. The subject has a history of bleeding disorder or is currently taking an anticoagulant or antiplatelet drug.
14. Subject has had signs or a history of gastrointestinal surgery, gastrointestinal ulceration or perforation in the past six months, gastrointestinal bleeding in the past year, or any sign or history of inflammatory bowel disease.
15. The subject is pregnant, actively attempting to become pregnant, or breastfeeding, or the subject is unwilling to take pregnancy tests.
16. The subject has evidence of illegal drug or alcohol abuse within the last year or another year of concurrent psychiatric illness which, in the investigator's opinion, is likely to affect study behavior and participation in the study.
17. Subject has participated in an investigational drug study in the past 4 weeks or plans to participate in another study at any time during that study.
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