Phase 3
Completed N=685
Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
Episodic Migraine
Source: ClinicalTrials.gov NCT03939312 ↗
Enrolled (actual)
685
Serious AEs
3.4%
Results posted
May 2022
Primary outcomePrimary: Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) — 62.5; 3.4 percentage of participants
◆ Published Evidence
Established
36citations · ~7 / year
Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults.
Summary
The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once a day for the prevention of migraine in participants with episodic migraine.
Linked Publications (4)
-
Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults.
-
A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial.
-
Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials.
-
Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) |
62.5; 3.4 | — |
| SECONDARY Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator |
0.3; 1.5; 0.3; 2.2; 0.6; 0.3 | — |
| SECONDARY Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator |
0.3; 0.5; 0.2; 0.3; 0.2; 3.4 | — |
| SECONDARY Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator |
1.9; 0.7; 0.1; 9.8; 0.6; 1.0 | — |
| SECONDARY Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) |
4; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Participants must be using a medically acceptable and effective method of birth control during the course of the entire study.
- 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 3101-301-002 (NCT03777059) without significant protocol deviations (eg, noncompliance to protocol-required procedures).
Exclusion Criteria
- 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.
- Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Data sourced from ClinicalTrials.gov (NCT03939312) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.