A Long-Term Safety and Tolerability Extension Study Evalu... | NCT04686136

ID	Type	Description	Link
2020-002470-27	EudraCT Number

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 19, 2021Actual

Primary Completion Date

Oct 20, 2025Actual

Completion Date

Oct 20, 2025Actual

First Submitted Date

Dec 21, 2020

First Submission Date that Met QC Criteria

Dec 23, 2020

First Posted Date

Dec 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

596Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atogepant 60 mg	Experimental	Taken once daily	Drug: Atogepant 60 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atogepant 60 mg	Drug	Tablets containing 60 mg of Atogepant	Atogepant 60 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event		156 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator		156 weeks
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that 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.
Participants with an ECG indicating clinically significant abnormalities at Visit 1.
Participants with hypertension at Visit 1.
Participants with a significant risk of self-harm, or of harm to others; 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duplicate_Barrow Neurological Institute /ID# 228217		Phoenix	Arizona	85013-4407	United States
California Headache and Balance Center /ID# 226241

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40831083	Derived	Ashina S, Ashina M, Holle-Lee D, Tassorelli C, Cho SJ, He MY, De Abreu Ferreira R, Gandhi P, Smith JH, Pfleeger K, Trugman JM. Long-term safety, efficacy and functional outcomes of atogepant for the preventive treatment of migraine. Cephalalgia. 2025 Aug;45(8):3331024251365206. doi: 10.1177/03331024251365206. Epub 2025 Aug 19.