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
- Conditions
- MigraineHeadache10019231
- Registration Number
- NL-OMON54251
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
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.
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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Percentage of Participants with at Least 1 Treatment Emergent Adverse Event<br /><br>across the 156-week treatment period</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Percentage of Participants with Clinically Significant Laboratory Values<br /><br>(Chemistry, Hematology, Urinalysis) as assessed by the Investigator [Time<br /><br>Frame: 156 weeks]<br /><br>- Percentage of Participants with Clinically Significant Electrocardiograms<br /><br>(ECGs) Findings as assessed by the Investigator [Time Frame: 156 weeks]<br /><br>- Percentage of Participants with Clinically Significant Vital Sign<br /><br>Measurements as assessed by the Investigator [Time Frame: 156weeks]<br /><br>- Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation<br /><br>and Behavior using 5-Point Scales [Time Frame: 156 weeks]</p><br>