NL-OMON54251招募中3 期
A Phase 3, Multicenter, Open-Label 156-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants with Chronic or Episodic Migraine - 3101-312-002
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5
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
- 18 至 99（—）
入选标准
- •1. Written informed consent and participant privacy information (eg, written
- •authorization for use and release of health and research study information)
- •obtained from the participant prior to initiation of any study-specific
- •procedures.
- •2. Participants must be using a medically acceptable and effective method of
- •birth control during the course of the entire study, as defined in Section
- •4.5.2 of the protocol.
- •3. Eligible participants who completed the double-blind treatment period (Visit
- •7) and the follow-up period (Visit 8), if applicable, depending on the timing
- •of study initiation, of Study 3101-303-002 or Study 3101-304-002 without
- •significant protocol deviations (eg, noncompliance to protocol-required
- •procedures) and who did not experience an AE that, in the investigator*s
- •opinion, may indicate an unacceptable safety risk.
排除标准
- •1. Requirement for any medication, diet (ie, grapefruit or grapefruit juice),
- •or nonpharmacological treatment that is on the list of prohibited concomitant
- •medications or treatments (see Section 4.5.1 and Attachment 12.1 of the study
- •protocol) that cannot be discontinued or switched to an allowable alternative
- •medication or treatment.
- •Exception: participants from lead-in Study 3101-303-002 taking only 1 migraine
- •prevention medication (with demonstrated efficacy, as listed in Attachment 12.1
- •of the protocol) at a stable, well-tolerated dose during the lead-in study; the
- •medication may be continued at the same dose or discontinued.
- •2. Female participant is pregnant, planning to become pregnant during the
- •course of the study, or currently lactating. WOCBP must have a negative urine
- •pregnancy test at Visit 1.
- •3. An ECG with clinically significant abnormalities at Visit 1 as determined by
- •the investigator.
- •4. Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting
- •diastolic BP > 100 mm Hg at Visit 1. Vital sign measurements that exceed these
- •limits may be repeated only once.
- •5. Significant risk of self-harm based on clinical interview and responses on
- •the C-SSRS, orof harm to others in the opinion of the investigator;
- •participants must be excluded if they report suicidal ideation with intent,
- •with or without a plan (ie, Type 4 or 5 on the C-SSRS) since the last visit.
- •6. Participants with clinically significant hematologic, endocrine,
- •cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic
- •7. Participant has a condition or is in a situation which in the investigator's
- •opinion may put the participant at significant risk, may confound the study
- •results, or may interfere significantly with participation in the study.
- •8. Any medical or other reasons (eg, unlikely to adhere to the study
- •procedures, keep appointments, or is planning to relocate during the study)
- •that, in the investigator*s opinion, might indicate that the participant is
- •unsuitable for participation in the study.
- •9. History of acute hepatitis within 6 months of screening (Visit 1); or
- •chronic liver disease (including nonalcoholic fatty liver disease, viral
- •chronic hepatitis, and cirrhosis).
研究者
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