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Calcitonin Gene-Related Peptide (CGRP) Antagonist

Atogepant for Migraine Prevention

Phase 3
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 156 weeks
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a drug called atogepant for preventing migraines in people who have them chronically or episodically.

Who is the study for?
This trial is for people who have chronic or episodic migraines and were part of earlier studies without major issues or serious side effects. They shouldn't need any off-limits treatments, have significant heart problems, uncontrolled high blood pressure, a risk of self-harm, or other serious health conditions.Check my eligibility
What is being tested?
The study tests the long-term safety and tolerability of Atogepant 60 mg taken daily to prevent migraines. It's an extension study for participants from previous trials on this medication.See study design
What are the potential side effects?
While not specified here, common side effects may include digestive discomforts like constipation or nausea, fatigue, dry mouth and potential allergic reactions. Each person might experience different side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I completed previous study visits without major issues or unsafe side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~156 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 156 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
Secondary outcome measures
Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
+1 more

Side effects data

From 2022 Phase 3 trial • 315 Patients • NCT04740827
10%
CONSTIPATION
8%
COVID-19
7%
NAUSEA
5%
NASOPHARYNGITIS
1%
ABORTION INDUCED
1%
INVASIVE BREAST CARCINOMA
1%
VENTRICULAR TACHYCARDIA
1%
BREAST CANCER STAGE II
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Atogepant 60 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Atogepant 60 mgExperimental Treatment1 Intervention
Taken once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atogepant 60 mg
2021
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
275,973 Total Patients Enrolled
10 Trials studying Migraine
5,869 Patients Enrolled for Migraine
Joel TrugmanStudy DirectorAllergan
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
78,663 Total Patients Enrolled
5 Trials studying Migraine
4,687 Patients Enrolled for Migraine

Media Library

Atogepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04686136 — Phase 3
Migraine Research Study Groups: Atogepant 60 mg
Migraine Clinical Trial 2023: Atogepant Highlights & Side Effects. Trial Name: NCT04686136 — Phase 3
Atogepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04686136 — Phase 3
Migraine Patient Testimony for trial: Trial Name: NCT04686136 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you tell me what other research studies have looked at Atogepant 60 mg?

"Atogepant 60 mg was first studied in 2020 at the Higashiosaka City Medical Center. So far, there have been 9 completed trials and 2 additional trials are still recruiting patients. The Ridgeland, Mississippi medical centre is playing a role in these ongoing studies."

Answered by AI

Is this clinical trial only open to people who are under 45 years old?

"This particular study is seeking patients that fall between 18-80 years old, which 33 other trials also focus on. In contrast, 116 trials focus on patients that are 65 years or older."

Answered by AI

Has anything like this been done before?

"At present, there are 2 open clinical trials for Atogepant 60 mg in 18 different countries and 140 cities. The first trial was sponsored by Allergan in 2020 and had 170 participants. It completed Phase 3 drug approval and since then, there have been 9 more studies."

Answered by AI

Are there any current openings in this research project for new participants?

"Trial recruitment for this study has concluded. The study's primary posting was on February 19th, 2021 with the most recent edit on September 21st, 2022. There are currently 169 other trials recruiting patients with episodic migraines and 2 trials for Atogepant 60 mg admitting participants."

Answered by AI

Would I be able to take part in this research if I signed up?

"Eligible patients for this study are those aged 18-80 who have episodic migraines. Additionally, these patients must have completed Visit 7 and 8 of Study 3101-303-002 or Study 3101-304-002 without any major protocol deviations. Lastly, they cannot have experienced any Adverse Events that would suggest an unacceptable safety risk."

Answered by AI

What is the Atogepant 60 mg stance on FDA regulations?

"Atogepant 60 mg ranked a 3 on our Power team's safety assessment scale. This is due to the fact that it is a Phase 3 trial, meaning that there is not just data supporting efficacy, but multiple rounds of data supporting safety."

Answered by AI

How many test facilities are conducting this experiment?

"There are 100 sites enrolling patients in this trial. To make the process more convenient for enrollees, locations were chosen to be close to major population centres."

Answered by AI

Who else is applying?

What state do they live in?
Washington
Texas
Florida
Other
How old are they?
18 - 65
What site did they apply to?
Pharmacology Research Institute
Headache Wellness Center
Highland Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0

Why did patients apply to this trial?

La necesidad de conseguir dinero extra. I've been experiencing severe migraines and looking for alternatives.
PatientReceived 2+ prior treatments
I’ve tried so many different drugs that haven’t worked and I’m hoping through this trial that I can find a solution.
PatientReceived no prior treatments
I get migraines a lot and I fo through excedrin migraine like candy. That seems to be the only thing that kind of helps. I'm definitely suffering and need relief.
PatientReceived 1 prior treatment
I've seen a doctor in the past about daily migraines, and his advice was merely to change my diet, as he felt the side effects would potentially cause worse functionality for me in the long run. I followed his advice and it worked for a short period of time before they came back worse.I get about 7-8 hours of sleep a night, I eat a clean diet, drink plenty of water, and I am active in the gym as well as regular walks with my dog, however, my migraines still persist every day, to the point where once one comes on (depending on severity and location of migraine), I know the rest of my day is over as I cannot be around bright lights, loud sounds, and smells of food make me nauseated.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do the screening visits take and how often do I have to travel to Greensboro? What day of the week will it be? If the drug works for me, will I be able to continue getting it after the trial is over?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
2021. "A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04686136.
All > Migraine Headaches > Migraine
~57 spots leftby Sep 2024
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