Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
Status: | Recruiting |
---|---|
Conditions: | Migraine Headaches |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 3/22/2019 |
Start Date: | March 11, 2019 |
End Date: | January 22, 2021 |
Contact: | Clinical Trials Registry Team |
Email: | IR-CTRegistration@allergan.com |
Phone: | 877-277-8566 |
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)
This study will evaluate the efficacy, safety and tolerability of atogepant in participants
with chronic migraine. This study includes a 12-week treatment period.
with chronic migraine. This study includes a 12-week treatment period.
Inclusion Criteria:
- At least a 1-year history of CM consistent with a diagnosis according to the ICHD-3,
2018
- Age of the participant at the time of migraine onset < 50 years
- Confirmation of headache/migraine headache day frequency as follows:
1. History of, on average, ≥ 15 headache days per month in the 3 months prior to
Visit 1 in the opinion of the investigator AND
2. ≥ 15 headache days during the 4-week screening/baseline period per the electronic
diary (eDiary) AND
3. ≥ 8 days during the 4-week screening/baseline period that qualify as being a
migraine day per the eDiary
- Participants must be using a medically acceptable and effective method of birth
control during the course of the entire study,
Exclusion Criteria:
- Has a history of migraine, accompanied by diplopia or decreased level of
consciousness, or retinal migraine
- Has a current diagnosis of new persistent daily headache, trigeminal autonomic
cephalgia (eg, cluster headache), or painful cranial neuropathy
- History of an inadequate response to > 4 medications (2 of which have different
mechanisms of action) prescribed for the prevention of migraine
- Woman 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 at Visit 1 and Visit 2.
We found this trial at
27
sites
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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