EUCTR2010-019203-31-PL进行中（未招募）不适用
A Multicenter, Double-blind, Randomized, Placebo-controlled, 4-Armed Parallel 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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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;
- •8. Have the ability to differentiate between migraine and non-migraine headaches;
- •9. 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, NuvaRing) plus condom, 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.
- •10. Absence of clinically significant abnormalities indicated from the medical history,
- •physical examination, laboratory assessments (clinical chemistry, hematology,
- •urinalysis), and urine drug screen results;
- •11. Clearly understands and is likely to comply with all study procedures and scheduled visits, as demonstrated during the run-in and placebo challenge period;
- •12. Ability to read and write and use the patient diary;
- •13. The investigator believes participation in the study will not be harmful to the
- •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
- •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 (i.e., migraine headache intensity is mild or none at 2 hours after the placebo challenge).
研究者
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