EUCTR2008-005010-43-ES进行中（未招募）1 期
Estudio doble ciego, aleatorizado y controlado con placebo con grupos paralelos para determinación de dosis de COL-144 por vía oral en el tratamiento agudo de la migraña
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- •Patients are eligible for the study if all of the following criteria are met:
- •1. Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1
- •and 1.2.1 (2004)
- •2. History of migraine of at least 1 year
- •3. Migraine onset before the age of 50 years
- •4. History of 1 ? 8 migraine attacks per month
- •5. Male or female patients aged 18 to 65 years
- •6. Female patients of child-bearing potential must be using a highly effective form of
- •contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized
- •7. Able and willing to give written informed consent
- •8. Able and willing to complete a migraine diary card to record details of the attack
- •treated with study medication
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •Patients are excluded from the study if any of the following criteria are met:
- •1. History of life threatening or intolerable adverse reaction to any triptan
- •2. Use of prescription migraine prophylactic drugs within 15 days (30 days for
- •flunarizine) prior to Screening Visit and during study participation
- •3. Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
- •4. Using 5-HT reuptake inhibitors
- •5. Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
- •6. Pregnant or breast-feeding women
- •7. Women of child-bearing potential not using highly effective contraception
- •8. History or evidence of coronary artery disease, ischemic or hemorrhagic stroke,
- •epilepsy or any other condition placing the patient at increased risk of seizures
- •9. History or current hypertension (controlled or uncontrolled)
- •10. History of orthostatic hypotension with syncope
- •11. Current use of hemodynamically active cardiovascular drugs
- •12. History within the previous 3 years or current evidence of abuse of any drug,
- •prescription or illicit, or alcohol
- •13. Significant renal or hepatic impairment
- •14. Previous participation in this clinical trial
- •15. Participation in any clinical trial of an experimental drug or device in the
- •previous 30 days
- •16. Any medical condition or laboratory test which in the judgment of the
- •investigator makes the patient unsuitable for the study
- •17. Known Hepatitis B or C or HIV infection
- •18. Patients who are employees of the sponsor
- •19. Relatives of, or staff directly reporting to, the investigator
- •20. Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists
- •or to any excipient of COL-144 drug product
- •21. Patients who were treated with study medication in the COL MIG-201 study
- •(Patients screened but not treated under that protocol are not excluded)
研究者
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