EUCTR2015-005674-37-DE进行中（未招募）1 期
An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR) - GLADIATOR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,171
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
- •All subjects entered into this trial must meet the following criteria:
- •1. Able and willing to give written informed consent
- •2. Completed COL MIG-301 or COL MIG-302 within the last 12 weeks.
- •3. 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).
- •4. Able and willing to complete an electronic diary to record details of all migraine attacks treated with study drug.
- •Inclusion criteria for sub-study:
- •use this subsection in addition to the corresponding subsection (with the
- •exception of inclusion criterion #2) in the main protocol:
- •[12] Have completed either COL MIG-301 or COL MIG-302.
- •[13] Have a Migraine Disability Assessment score (MIDAS) score =11
- •(see Appendix 2 of the main protocol)
- •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 2451
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 129
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. Subject is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS).
- •5. Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301 or COL MIG-302.
- •6. Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG-301 or COL MIG-302.
- •7. Subject did not dose a migraine during the allotted time while enrolled in COL MIG-301 or COL MIG-302 or was evaluated to be noncompliant with the e-diary requirements (particularly recording their migraine and post-dose assessments).
- •Exclusion criteria sub-study
- •Use this subsection in addition to the corresponding subsection in the
- •main protocol:
- •[5] Exclusion criterion #5 from the main protocol (Initiation of or a
- •change in concomitant medication to reduce the frequency of migraine
- •episodes since completing COL MIG-301 or COL MIG-302) is not
- •exclusionary for those subjects participating in this protocol addendum
- •and has been deleted.
- •[14] Subject did not dose a migraine during the allotted time while
- •enrolled in COL MIG-302 or was evaluated to be noncompliant with the
- •requirements (particularly recording their migraine and post-dose
- •assessments). In exceptional circumstances, and with the prior approval
- •of the Sponsor, patients previously considered ineligible due to this
- •criterion may be reconsidered.
- •Refer to the main protocol for the remainder of Section 6.
研究者
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