To Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine



Status:Active, not recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:3/27/2019
Start Date:October 8, 2018
End Date:November 9, 2020

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A Phase 3, Multicenter, Randomized, Open-label Study to Evaluate the Long-term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine.

Safety and tolerability of treatment with atogepant for the prevention of episodic migraine
over the course of one year


Inclusion Criteria:

- Written informed consent and participant privacy information (eg, written
authorization for use and release of health and research study information) obtained
from the participant prior to initiation of any study-specific procedures.

- Participant is a candidate to be prescribed at least one of the protocol-defined
acceptable oral SOC (Standard of Care) migraine prevention medications and the
participant is willing to accept SOC (Standard of Care) treatment.

- Participants must be using a medically acceptable and effective method of birth
control during the course of the entire study,

- At least a 1-year history of migraine with or without aura consistent with a diagnosis

- Age of the participant at the time of migraine onset < 50 years

- History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

Exclusion Criteria:

- Difficulty distinguishing migraine headaches from tension-type or other headaches

- Has a history of migraine accompanied by diplopia or decreased level of consciousness
or retinal migraine

- Has a current diagnosis of CM, new persistent daily headache, trigeminal autonomic
cephalgia (eg, cluster headache), or painful cranial neuropathy

- ≥ 15 headache days per month on average across the 3 months prior to Visit 1

- Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month,
or simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days/month in the 3
months prior to Visit 1 per investigator's judgment, or during the baseline period.
For all participants, barbiturates are excluded 30 days prior to screening and during
the baseline period. For participants randomized to atogepant, barbiturates are
excluded through the duration of the study as well

- Female participant is pregnant, planning to become pregnant during the course of the
study, or currently lactating. Women of childbearing potential must have a negative
urine pregnancy test

- Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, GI, or
neurologic disease

- Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP >
100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may
be repeated only once.

- At Visit 1, a user of recreational or illicit drugs or has had a history within the
past year of drug or alcohol abuse or dependence

- History of any GI prior procedures or GI conditions (eg, diarrhea syndromes,
inflammatory bowel disease) that may affect the absorption or metabolism of atogepant;
participants with prior gastric bariatric interventions (eg, Lap Band) which have been
reversed are not excluded.
We found this trial at
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Austin, Texas 78745
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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3555 NW 58th St # 800
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