Phase 3
Completed N=744
Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
Source: ClinicalTrials.gov NCT03700320 ↗Enrolled (actual)
744
Serious AEs
4.2%
Results posted
Jun 2021
Primary outcomePrimary: Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) — 78.6; 67.0 percentage of participants
◆ Published Evidence
Established
27citations · ~5 / year
A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial.
Summary
This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.
Linked Publications (5)
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A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial.
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Patient-reported migraine-specific quality of life, activity impairment and headache impact with once-daily atogepant for preventive treatment of migraine in a randomized, 52-week trial.
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Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials.
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Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis.
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Sustained response to atogepant in episodic migraine: post hoc analyses of a 12-week randomized trial and a 52-week long-term safety trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) |
78.6; 67.0 | — |
| SECONDARY Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator |
0.0; 0.6; 1.6; 1.7; 0.0; 0.2 | — |
| SECONDARY Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator |
0.0; 0.2; 0.6; 0.4; 0.6; 0.0 | — |
| SECONDARY Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator |
3.7; 2.6; 0.0; 0.4; 5.8; 3.4 | — |
| SECONDARY Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior |
4; 0; 1; 2; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
- Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment.
- Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
- At least a 1-year history of migraine with or without aura consistent with a diagnosis
- Age of the participant at the time of migraine onset 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
- 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
- Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease
- Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of mercury (mm Hg) or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once.
- At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
- History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.
Data sourced from ClinicalTrials.gov (NCT03700320) 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.