NCT04686136

A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine

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

Interventional study

Status:
Active, not recruiting
Conditions:
Episodic Migraine
Chronic Migraine
Enrollment:
596 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
3101-312-002
Allocation:
N/A
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 80 Years.

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.

All the cities where the clinical studies are located

Calgary - T3M 1M4
Victoria - V8R 1J8
Brampton - L6T 0G1
Ottawa - K2G 6E2
Sherbrooke - J1L 0H8

Alberta

British Columbia

Quebec

More information about this study

clinicaltrials.gov