EUCTR2010-019203-31-FI进行中（未招募）1 期
A Multicenter, Double-blind, Randomized, Placebo-controlled, 4-ArmedParallel Group Study to Evaluate the Efficacy of Zolmitriptan 0.5-, 2.5- and 5-mg Nasal Spray in the Treatment of Acute Migraine Headache inAdolescents - TEENZ
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 798
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Parent or legal guardian is able to provide written informed consent and patient is able to provide written assent.
- •2. Adolescents aged 12 to 17 years at the time of screening; patients must not be enrolled if they will turn 18 years of age within 10 weeks after randomization (Visit 2).
- •3. An established diagnosis of migraine (history indicating the presence of migraine for at least 1 year) with or without aura as defined by the IHS or IHS-R criteria. Patients with medical history of migraine for at least 1 year prior to screening as defined by IHS or IHS-R criteria without a historic documentation of migraine may be considered for entry after the history has been established and discussed with the medical monitor;
- •4. A minimum of 2 migraines, considered to be moderately/severely disabling, per month (by history);
- •5. A medical history of usual untreated migraine duration of =3 hours for any 3 month period prior to screening (Visit 1);
- •6. A history of migraine attacks occurring at intervals of >24 hours apart, which is confirmed by medical history;
- •7. Have the ability to differentiate between migraine and non-migraine headaches;
- •8. All females in a relationship capable of producing a pregnancy should use a highly effective form of birth control. All females will have a pregnancy test. They must have a negative urine pregnancy test and confirmed (by the investigator) use of a highly effective form of birth control. The highly effective form of birth control includes, but is not limited to, total sexual abstinence, a vasectomized male partner
- •with confirmation of azoospermia plus condom, female sterilization by tubal occlusion plus condom, intrauterine devices (IUD, ie, copper banded coils plus condom, intrauterine systems (IUS, ie, levonorgestrel [eg, Mirena] plus condom), Depo-Provera plus condom, etonogestrel implants (eg, Implanon, Norplant, Nuva ring) plus condom, Ortho Evra plus condom, normal and low-dose combined oral
- •contraceptives plus condom, norelgestromin/ethinyl estradiol (EE) transdermal system plus condom, intravaginal device (eg, EE and etonogestrel) plus condom, and Cerazette (desogestrel) – currently the only highly effective progesterone-based pill – plus condom. A diaphragm and foam or condom or sponge and condom are
- •not acceptable. Females should be on a stable method of birth control for a minimum of 3 months prior to study entry.
- •9. Absence of clinically significant abnormalities indicated from the medical history, physical examination, laboratory assessments (clinical chemistry, hematology, urinalysis), and urine drug screen results;
- •10. Clearly understands and is likely to comply with all study procedures and scheduled visits, as demonstrated during the run-in and placebo challenge period;
- •11. Ability to read and write and use the patient diary;
- •12. The investigator believes participation in the study will not be harmful to the patient.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1000
- •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
排除标准
- •1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site);
- •2. Had previous randomization of treatment in this study;
- •3. Is currently participating or has participated in another clinical study within 30 days prior to screening for this study;
- •4. Any medical condition that may put the patient at increased risk with exposure to zolmitriptan or that may interfere with the safety or efficacy assessments (in the opinion of the investigator);
- •5. A history of basilar, ophthalmoplegic, or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache;
- •6. Had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug (in the opinion of the investigator);
- •7. Evidence of ischemic heart disease, arrhythmia (eg, atrial fibrillation or flutter, frequent premature ventricular contractions, atrioventricular block), accessory conduction pathway disorder (eg, Wolff-Parkinson-White syndrome) as determined by central cardiologist using predetermined and agreed upon pediatric standards;
- •8. History, symptoms, or significant risk factors for ischemic heart (eg, silent ischemia, angina, myocardial infarction) or other cardiovascular disease, including coronary vasospasm, cardiac accessory conduction pathways, arrhythmias, cerebrovascular syndromes (eg, stroke), or peripheral vascular disease;
- •9. Clinically significant abnormalities indicated from the medical history, physical examination, clinical chemistry, hematology, and urine drug screen (eg, stable diabetes mellitus would not qualify as a clinically significant abnormality for the purposes of this study);
- •10. Had a diagnosis or suspicion of drug-induced or chronic daily headaches within 1 year;
- •11. Has 14 or more non-migraine headache days each month for 3 months before the screening visit;
- •12. Has uncontrolled hypertension defined as systolic or diastolic BP that exceeds the 95th percentile for age and height (Appendix E; NHBPEP 2005);
- •13. Has used monoamine oxidase-A (MAO-A) inhibitor, methysergide,
- •methylergonovine, or cimetidine in the 2 weeks before randomization or an SSRI 4 weeks before randomization; if the patient has been on stable dose of SSRI for 8 weeks (2 months) prior to randomization, they may be included in the study.
- •14. Has any recent history of abuse (in the previous year) of alcohol or other drugs including drugs for the acute treatment of headache;
- •15. Is a female who is pregnant or breast-feeding;
- •16. Has severe hepatic impairment or any serious condition which, in the opinion of the investigator, would present a risk to the patient participating in the study;
- •17. Has a clinically relevant abnormality on nasopharyngeal examination as determined by the investigator; nasopharyngeal examination means a standard physical examination to rule out gross abnormalities of the nasopharynx and does not imply specialist examination prior to enrolling a patient.
- •18. Has a positive urine test for drug abuse not explained by the use of appropriately prescribed rescue medications.
- •19. Responds to the placebo challenge during the run-in period (ie, migraine headache intensity is mild or none at 2 hours after the placebo challenge).
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