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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 overuse as defined in the protocol
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 28 weeks
Awards & highlights
Study Summary
This trial will assess if atogepant is a safe and effective drug to prevent chronic migraine when taken with Botox.
Who is the study for?
Adults with chronic migraine who've been treated with BOTOX for at least two cycles in the past 8 months and have had 8-23 migraine days during a screening period. Participants must not have used certain migraine medications recently, including CGRP pathway blockers or oral gepants, and should not be on other preventive treatments besides BOTOX.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of an investigational drug called Atogepant when added to standard BOTOX treatment for preventing migraines. Around 125 participants will take Atogepant daily for 24 weeks while continuing their regular BOTOX injections.See study design
What are the potential side effects?
Possible side effects from adding Atogepant to BOTOX may include reactions typical of migraine prevention medications such as nausea, fatigue, dry mouth, or digestive issues. The study will closely monitor any adverse events throughout its duration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had chronic migraines for at least a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 28 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Monthly Migraine Days
Change from Baseline in Monthly Activity Impairment in Migraine - Diary (AIM-D)
Change from Baseline in Monthly Headache Days, Moderate or Severe Headache Days, Cumulative Hours of Headache, Acute Treatment Medication Use Days, Headache Free Days, and Migraine Symptom-Free Days
+7 moreOther outcome measures
Change From Baseline in Mean Monthly Migraine Days
Side effects data
From 2020 Phase 3 trial • 744 Patients • NCT0370032010%
Upper respiratory tract infection
7%
Constipation
6%
Nausea
5%
Urinary tract infection
4%
Nasopharyngitis
3%
Fatigue
3%
Dizziness
3%
Anxiety
1%
Paraesthesia
1%
Weight increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atogepant 60 mg
Oral SOC Migraine Preventive Medication
Trial Design
1Treatment groups
Experimental Treatment
Group I: AtogepantExperimental Treatment1 Intervention
Participants will receive atogepant once a day (QD) during the 24-week treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atogepant
2018
Completed Phase 4
~3490
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
502,309 Total Patients Enrolled
10 Trials studying Migraine
7,659 Patients Enrolled for Migraine
AllerganLead Sponsor
781 Previous Clinical Trials
276,494 Total Patients Enrolled
10 Trials studying Migraine
5,869 Patients Enrolled for Migraine
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,184 Total Patients Enrolled
5 Trials studying Migraine
4,687 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been receiving BOTOX for chronic migraines, with at least 2 treatments in the last 8 months.I've used opioids for headaches more than 4 days a month recently.I have had chronic migraines for at least a year.I have had chronic migraines for at least a year.You must have experienced 8 to 23 migraine days within the screening period, and your eDiary must have recorded at least 20 days of data.I haven't had treatments like acupuncture or TENS on my head/neck muscles in the last 4 weeks.I have used CGRP-blocking medication in the last 6 months.I haven't taken oral migraine medication in the last 4 weeks.I am not using migraine prevention treatments other than BOTOX or low-dose topiramate.I have been receiving BOTOX for chronic migraines and have completed at least 2 treatment cycles in the last 8 months.
Research Study Groups:
This trial has the following groups:- Group 1: Atogepant
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Migraine Patient Testimony for trial: Trial Name: NCT05216263 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If a patient meets the eligibility requirements, can they enroll in this clinical trial today?
"Unfortunately, this study is not currently looking for patients as it is not in the recruitment stage. The trial was posted on November 1st, 2020 but was last edited on October 17th, 2020. Although this specific study is not looking for patients, there are 169 other clinical trials that are."
Answered by AI
In how many medical facilities can patients participate in this clinical trial?
"This trial is being conducted at 27 different locations, some of which are MedVadis Research /ID# 242948 in Waltham, Massachusetts, Hope Clinical Research /ID# 241772 in Canoga Park, California, and Dent Neurosciences Research Center, Inc. /ID# 241776 in Amherst, New york."
Answered by AI
What is the side effect profile of Atogepant?
"Atogepant's safety has been backed by both efficacy data as well as multiple rounds of safety trials, warranting a score of 3."
Answered by AI
Does this research study welcome elderly participants?
"This particular study requires that applicants are aged between 18 and 75. There are 33 clinical trials that allow patients who are under 18 and 114 for patients who are over the age of 65."
Answered by AI
Who else is applying?
What state do they live in?
Florida
West Virginia
California
What site did they apply to?
Hope Clinical Research /ID# 241772
Neurological Research Institute /ID# 242688
Neuro Pain Medical Center /ID# 241992
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
1
Why did patients apply to this trial?
Hopping this medical trial will help me and my migraines ! IVE TRIED MANY DIFFERENT MEDICATIONS AND REMEDIES FOR RELIEF AND PREVENTION WITH LITTLE TO NO LUCK. IM WILLING TO DO ANYTHING AT THIS POINT.
PatientReceived 2+ prior treatments
I applied because I’ve had chronic migraines for the past 19 years. There aren’t many trials in my area, so being able to apply made me happy and eager to do so.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How often would I need to be there?
PatientReceived no prior treatments
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