Phase 3 Open label clinical trial with oral Atogepant for the prevention of migraine

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 670

Inclusion Criteria

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.
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 639
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

Exclusion Criteria

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 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 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, or of 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 disease;
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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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