Trial studying safety and effects for Migraine
Official title Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
ClinicalTrials.gov ID: NCT06972056
What this study is testing
What is Atogepant 60 mg?
An investigational oral tablet being studied as a preventive treatment for migraine. It is designed to block the CGRP receptor, which is involved in migraine pathways.
Also referred to as Qulipta.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out which of the three preventive medicines is most effective and easiest to tolerate for migraine sufferers.
- Who it's for
- Adults who experience migraine headaches.
- What's involved
- Participants will be randomly assigned to take one of the three medicines, keep a daily headache diary, and attend study visits for assessments.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Adults, 18-70 years of age at the time of enrollment
- Migraine with aura, migraine without aura, and/or chronic migraine; according to ICHD-3 diagnostic criteria.
- Migraine onset prior to 50 years of age
- Migraine present for at least 12 months at the time of enrollment
- At least four "moderate to severe headache days" per month (by patient self-report and then confirmed during four-week pre-randomization headache...
You likely can't join if
- Contraindications to taking atogepant, propranolol, or topiramate.
- Currently taking atogepant, propranolol, or topiramate\
- Previously took atogepant, propranolol, or topiramate\
- Unwillingness to take atogepant, topiramate, or propranolol.
- Current use of a CGRP-targeting preventive medication or beta-blocker
- Migraine with brainstem aura
See the full eligibility criteria
- Adults, 18-70 years of age at the time of enrollment
- Migraine with aura, migraine without aura, and/or chronic migraine; according to ICHD-3 diagnostic criteria. (Those with daily or continuous headaches are not excluded.)
- Migraine onset prior to 50 years of age
- Migraine present for at least 12 months at the time of enrollment
- At least four "moderate to severe headache days" per month (by patient self-report and then confirmed during four-week pre-randomization headache diary phase) A "moderate to severe headache day" is defined as a day...
- If already taking a migraine preventive treatment, willing to continue with that treatment without dose change during the first 16 weeks of the study, including the 4-week run-in phase and 12-week assigned by chance...
- Not pregnant or breastfeeding
- Women of childbearing potential must agree to use effective methods of contraception to reduce the risk of pregnancy.
- Willingness and ability to provide informed consent.
- Willingness and ability to complete all research visits.
- Contraindications to taking atogepant, propranolol, or topiramate.
- Currently taking atogepant, propranolol, or topiramate\
- Previously took atogepant, propranolol, or topiramate\
- Unwillingness to take atogepant, topiramate, or propranolol.
- Current use of a CGRP-targeting preventive medication or beta-blocker
- Migraine with brainstem aura
- Hemiplegic migraine
- Retinal migraine
- Migraine aura without headache (exclusively)
- Pure menstrual migraine
- Trigeminal autonomic cephalalgias
- Facial neuralgias
- Secondary headache disorders (medication overuse headache is not an exclusion)
- Migraine preventive treatment has been started or dose has been changed within 12 weeks prior to potential enrollment.
- Used opioids or butalbital on five or more days per month on average for at least 3 months prior to enrollment.
- Current or past epilepsy
- Severe hepatic impairment
- Moderate or more severe renal impairment \ Occasional as needed use of propranolol, currently or in the past, is not an exclusion, such as taking as needed propranolol for treatment of anxiety.
The study team makes the final eligibility decision.
Where it is enrolling
- Flagstaff, Arizona, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Palm Springs, California, United States
- Pomona, California, United States
- Aurora, Colorado, United States
- Hollywood, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Overland Park, Kansas, United States
- Hyde Park, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Reno, Nevada, United States
- Edison, New Jersey, United States
- Kingston, New York, United States
- Manhasset, New York, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Flagstaff, Arizona, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; Palm Springs, California, United States; Pomona, California, United States; Aurora, Colorado, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.