Phase 3 N=3 Prevention

Study to Assess Adverse Events (AEs) When Oral Atogepant Tablet is Given to Adult Chinese Participants Who Completed Study 3101-303-002 to Prevent Chronic Migraine

Chronic Migraine

Bottom Line

View on ClinicalTrials.gov: NCT04829747 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Number of Participants With Adverse Events — 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Atogepant (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	1	—
PRIMARY Number of Participants With Significant Change in Clinical Laboratory Determinations	—	—
PRIMARY Number of Participants With Significant Change in Vital Sign Measurements	—	—
PRIMARY Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters	—	—
PRIMARY Number of Participants With a Change in Columbia-Suicide Severity Rating Scale (C-SSRS)	—	—

Summary

Migraine is characterized by attacks of throbbing, moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The main objective of the study is to evaluate how safe and effective the atogepant is in preventing chronic migraine in adult Chinese participants who completed study 3101-303-002. Adverse events will be monitored. Atogepant is an investigational drug being developed to prevent chronic migraine. All participants will receive the same treatment. Approximately 120 adult participants who completed study 3101-303-002 will be enrolled at approximately 25 centers in China. All participants will receive atogepant oral tablet once daily for 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility Criteria

Inclusion Criteria

Eligible participants completed the double-blind treatment period, and the safety follow-up period, if applicable, depending on the timing of study initiation, of Study 3101-303-002 without significant protocol deviations and who did not experience an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.

Exclusion Criteria

Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments, that cannot be discontinued or switched to an allowable alternative. Concomitant medications with demonstrated efficacy for the prevention of migraine is exclusionary, except that participants from lead-in study 3101-303-002 taking 1 medication with demonstrated efficacy for the prevention of migraine may participate in the current study provided that the dose was stable prior to the lead-in study and the participant is willing to continue taking that medication.
Participants with an electrocardiogram (ECG) indicating clinically significant abnormalities at Visit 1.
Participants with hypertension (sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic BP > 100 mm Hg) at Visit 1.
Participants with a significant risk of self-harm Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others (investigator opinion); participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04829747). 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.