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 Clinical Trial

Official title:

A Phase 3, Multicenter, Open-Label, 12-Week Study to Evaluate the Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Chinese Participants With Chronic Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829747
• Other study ID #: 3101-311-002
• Status: Completed
• Phase: Phase 3
• Start date: August 2, 2021
• Est. completion date: January 20, 2022

Study information

• Verified date: April 2023
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant
Oral Tablet

Locations

Country	Name	City	State
China	Chinese PLA General Hospital /ID# 227546	Beijing	Beijing
China	The second Affiliated hospital of Zhejiang University school of Medicine /ID# 227558	Hangzhou	Zhejiang
China	The Second Hospital of Shanxi Medical University /ID# 227567	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity.	Baseline of the study 3101-303-002 to 16 weeks
Primary	Number of Participants With Significant Change in Clinical Laboratory Determinations	Number of participants with clinically significant change from baseline for any detectable clinical laboratory tests like hematology will be reported.	Baseline of the study 3101-303-002 to 16 weeks
Primary	Number of Participants With Significant Change in Vital Sign Measurements	Number of participants with clinically significant change from baseline for any vital signs like standing BP, sitting and standing pulse rate will be reported.	Baseline of the study 3101-303-002 to 16 weeks
Primary	Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters	12-lead ECG will be performed.	Baseline of the study 3101-303-002 to 12 weeks
Primary	Number of Participants With a Change in Columbia-Suicide Severity Rating Scale (C-SSRS)	The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 being wish to be dead and 5 being active suicidal ideation with specific plan and intent. Suicidal behavior is classified on a 5-item scale: 0 being no suicidal behavior and 4 being actual attempt.	Baseline of the study 3101-303-002 to 16 weeks