JPRN-jRCT2080225228招募中3 期
A Phase 3, Multicenter, Open-Label 52-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Participants with Chronic or Episodic Migraine
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Eligible participants who completed the double-blind treatment period of Study 3101-303-002 or Study 3101-305-002 without significant protocol deviations and who did not experience an AE that,in the investigator's opinion, may indicate an unacceptable safety risk
- •-Participants must be using a medically acceptable and effective method of birth control during the course of the entire study
排除标准
- •- Requirement for any medication, diet, or nonpharmacological treatment that is on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative medication or treatment
- •- Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1
- •- Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Visit 1
- •-Significant risk of self-harm based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator
- •-Any clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease
研究者
相似试验
进行中（未招募）
1 期
Phase 3 Open label clinical trial with oral Atogepant for the prevention of migraineEUCTR2020-002470-27-SEAllergan Limited670
进行中（未招募）
1 期
Phase 3 Open label clinical trial with oral Atogepant for the prevention of migraineChronic or Episodic Migraine (Migraine without aura, migraine with aura, or chronic migraine)MedDRA version: 20.0Level: HLTClassification code 10027603Term: Migraine headachesSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: LLTClassification code 10066636Term: Chronic migraineSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 22.0Level: LLTClassification code 10082019Term: Episodic migraineSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10052787Term: Migraine without auraSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10027607Term: Migraine with auraSystem Organ Class: 10029205 - Nervous system disordersEUCTR2020-002470-27-FRAllergan Limited670
进行中（未招募）
1 期
Phase 3 Open label clinical trial with oral Atogepant for the prevention of migraineEUCTR2020-002470-27-ITALLERGAN LIMITED670
进行中（未招募）
不适用
A study to examine the study drug, SPD489, in subjects with major depressive disorder (MDD) who are taking certain types of antidepressants and continuing to have MDD symptoms.Major Depressive DisorderEUCTR2011-003019-47-BEShire Development Inc.1,700
进行中（未招募）
不适用
A study to examine the study drug, SPD489, in subjects with major depressive disorder (MDD) who are taking certain types of antidepressants and continuing to have MDD symptoms.Major Depressive DisorderEUCTR2011-003019-47-FIShire Development Inc.1,700