EUCTR2015-005689-40-GB进行中（未招募）1 期
A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute TReaTment of MigrAiNe: A randomized, double-blind, placebo-controlled parallel group study (SPARTAN) - SPARTA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,005
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
入选标准
- •All subjects entered into this trial must meet the following criteria:
- •1. Able and willing to give written informed consent
- •2. Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (ICHD-2004).
- •3. History of disabling migraine for at least 1 year.
- •4. MIDAS score =11.
- •5. Migraine onset before the age of 50 years.
- •6. History of 3 – 8 migraine attacks per month (< 15 headache days per month).
- •7. Male or female, aged 18 years or above.
- •8. Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, IUD, abstinence, or vasectomized partner).
- •9. Able and willing to complete an electronic diary to record details of the migraine attack treated with study drug.
- •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 2671
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 297
排除标准
- •Subjects will be excluded from this trial if they meet any of the following criteria:
- •1. Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
- •2. Pregnant or breast-feeding women.
- •3. Women of child-bearing potential not using or not willing to use highly effective contraception.
- •4. Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets, or any sensitivity to a ditan.
- •5. History or evidence of haemorrhagic stroke, epilepsy or any other condition placing the subject at increased risk of seizures.
- •6. History of recurrent dizziness and/or vertigo including BPPV, Meniere’s disease, vestibular migraine, and other vestibular disorders.
- •7. History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
- •8. History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.
- •9. History of orthostatic hypotension with syncope.
- •10. Significant renal or hepatic impairment.
- •11. Subject is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within six months prior to the screening visit.
- •12. Previous participation in this clinical trial.
- •13. Participation in any clinical trial of an experimental drug or device in the previous 30 days.
- •14. Known Hepatitis B or C or HIV infection.
- •15. History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is =15 headache days per month.
- •16. Use of more than 3 doses per month of either opiates or barbiturates.
- •17. Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.
- •18. Subjects who are employees of the sponsor.
- •19. Relatives of, or staff directly reporting to, the Investigator.
研究者
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