Cronic or Episodic Migraine (Migraine without aura, migraine with aura, or chronic migraine) MedDRA version: 20.0 Level: HLT Classification code 10027603 Term: Migraine headaches System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1 Level: LLT Classification code 10066636 Term: Chronic migraine System Organ Class: 10029205 - Nervous system d
Conditions
Interventions
Product Name: Atogepant
Product Code: AGN-241689
Pharmaceutical Form: Tablet
INN or Proposed INN: Atogepant
CAS Number: 1374248-81-3
Current Sponsor code: AGN-241689
Other descriptive name: MK-8031
L-004880174-008A
L-004880174
C11051808-H
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Sponsors
Allergan Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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 647 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of treatment with atogepant 60 mg once daily when administered over 52 weeks for the prevention of migraine in participants with CM or EM.;Secondary Objective: N/A;Primary end point(s): Since the primary objective of this study is to assess the long-term safety and tolerability of atogepant treatment, efficacy variables are not classified as primary, secondary, or additional. Efficacy endpoints for long-term efficacy evaluation in the atogepant arm are listed below: - Change from baseline in monthly migraine days for each monthly period (4-week intervals after Visits 4, 6 and 8); - Change from baseline in monthly headache days at each monthly period (4-week intervals after Visits 4, 6 and 8); - Change from baseline in monthly acute medication use days at each monthly period (4-week intervals after Visits 4, 6 and 8); - Change from baseline in monthly triptan use days at each monthly period (4-week intervals after Visits 4, 6 and 8); - = 25%, = 30%, = 50%, = 75%, and 100% improvement (decrease) of monthly migraine days, at each monthly period (4-week intervals after Visits 4, 6 and 8); - Change from baseline in monthly moderate/severe headache days at each monthly period (4-week intervals after Visits 4, 6 and 8);Timepoint(s) of evaluation of this end point: As described within the list of endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Australia, Canada, Czechia, Czech Republic, Denmark, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactCTRG
Allergan Ltd.
Outcome results
None listed