Overview

Study of Oral Atogepant Tablets When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine

Status:
Not yet recruiting
Trial end date:
2023-10-17
Target enrollment:
0
Participant gender:
All
Summary
Migraine is characterized by attacks of throbbing, moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. Adverse events and change in disease activity will be monitored. Atogepant is an investigational drug being developed to prevent chronic migraine. All participants will receive the same treatment. Approximately 125 adult participants will be enrolled at approximately 25 sites in the United States. All participants will receive atogepant oral tablet once daily during the 24-week treatment period. 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
Criteria
Inclusion Criteria:

- At least a 1-year history of chronic migraine (CM), with or without aura, consistent
with a diagnosis according to International Classification of Headache Disorders 3rd
edition (ICHD-3 2018) and with or without acute medication as defined in the protocol.

- Must be currently treated with BOTOX for CM: treated with >= 2 treatment cycles in the
8 months prior to Visit 2 (Day 1).

- Must have 8 to 23 (inclusive) migraine days in the 28-day Screening/Baseline period
(as assessed with eDiary).

Exclusion Criteria:

- Use of opioid-containing products for more than 4 days for acute treatment of headache
in the 3 months prior to Screening (Visit 1) or during the 28-day Screening/Baseline
period.

- Treatment of study target muscles using acupuncture, transcutaneous electrical nerve
stimulation (TENS), cranial traction, dental splints for headache, or injection of
anesthetics/steroids within 4 weeks prior to Screening (Visit 1).

- Concurrent use of any migraine prevention treatment other than BOTOX (including use of
oral gepants) in the 4 weeks prior to Visit 1 nor during the Screening/Baseline
period.

- Current use or use within the 6 months (24 weeks) prior to Screening (Visit 1), of
mAbs blocking the CGRP pathway.

- Concurrent use of oral gepants for acute migraine treatment in the 4 weeks prior to
Visit 1 nor during the screening/baseline period.