AzTrials
AzTrials

Episodic MigrainePhase 3NCT05711394

A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine

A Phase 3 study testing Atogepant in people with Episodic Migraine, run by AbbVie at 98 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Episodic Migraine
What is being tested?
Atogepant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
98 sitesin 16 countries
Study dates
1 May 2023to May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
  • History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.
  • Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day baseline period per eDiary.
  • To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 [2018]) and per investigator judgment is appropriate to receive preventive treatment for migraine.

Who cannot join

  • History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
  • Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).
  • Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).

Trial locations and contacts

98 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

98 sites in 16 countries

United States42 sites, 26 recruiting

  • Dent Neurologic Institute - Amherst /ID# 248534

    Amherst, New York, 14226

    Site Coordinator, 716-558-5670

    Recruiting

  • Advanced Research Center /ID# 251381

    Anaheim, California, 92805

    Recruiting

  • Michigan Headache & Neurological Institute (MHNI) /ID# 247468

    Ann Arbor, Michigan, 48104-5131

    Site Coordinator, 734-677-6000

    Recruiting

  • UT Health Austin at Dell Children's Neurology Clinic /ID# 264082

    Austin, Texas, 78723-3079

    Recruiting

  • FutureSearch Trials of Neurology /ID# 247470

    Austin, Texas, 78731

    Completed

  • Pantheon Clinical Research /ID# 251601

    Bountiful, Utah, 84010-4968

    Recruiting

  • Coastal Georgia Child Neurology /ID# 249733

    Brunswick, Georgia, 31520-1601

    Site Coordinator, 770-376-7912

    Recruiting

  • Patient Priority Clinical Sites, LLC /ID# 247535

    Cincinnati, Ohio, 45215-2123

    Site Coordinator, 513-791-7760

    Recruiting

  • Cincinnati Childrens Hospital Medical Center /ID# 258070

    Cincinnati, Ohio, 45229

    Recruiting

  • Alpine Research Organization - Clinton /ID# 276497

    Clinton, Utah, 84015

    Recruiting

  • 3A Research - East El Paso /ID# 248516

    El Paso, Texas, 79925-7945

    Completed

  • Core Clinical Research /ID# 249721

    Everett, Washington, 98201

    Completed

  • Advanced Neurosciences Research, LLC /ID# 247592

    Fort Collins, Colorado, 80528

    Completed

  • Office of Maria Ona /ID# 249738

    Franklin, Virginia, 23851

    Recruiting

  • Earle Research /ID# 248501

    Friendswood, Texas, 77546

    Site Coordinator, 281-218-8080

    Recruiting

  • Headache Wellness Center /ID# 251018

    Greensboro, North Carolina, 27405

    Recruiting

  • Northwest Florida Clinical Research Group, LLC /ID# 251382

    Gulf Breeze, Florida, 32561-4495

    Completed

  • Advanced Research Institute of Miami /ID# 248539

    Homestead, Florida, 33030-4613

    Completed

  • Rehabilitation & Neurological Services /ID# 248517

    Huntsville, Alabama, 35805-4046

    Recruiting

  • Preferred Research Partners /ID# 249729

    Little Rock, Arkansas, 72211

    Recruiting

  • Preferred Research Partners /ID# 270406

    Little Rock, Arkansas, 72211

    Completed

  • Alliance for Research Alliance for Wellness /ID# 248521

    Long Beach, California, 90807

    Recruiting

  • Le Bonheur Children's Hospital /ID# 261084

    Memphis, Tennessee, 38103

    Completed

  • My Preferred Research LLC /ID# 249720

    Miami, Florida, 33155

    Recruiting

  • Goryeb Childrens Hospital /ID# 249724

    Morristown, New Jersey, 07960

    Recruiting

  • Access Clinical Trials, Inc. /ID# 248532

    Nashville, Tennessee, 37203

    Recruiting

  • Modern Migraine MD /ID# 258074

    New York, New York, 10001

    Completed

  • Deaconess Clinic - Gateway Health Center /ID# 247589

    Newburgh, Indiana, 47630

    Site Coordinator, 812-474-7184

    Recruiting

  • Excell Research, Inc /ID# 247532

    Oceanside, California, 92056

    Completed

  • Lynn Institute of Oklahoma City /ID# 247600

    Oklahoma City, Oklahoma, 73112

    Completed

  • College Park Family Care Center Overland Park /ID# 249734

    Overland Park, Kansas, 66210-2761

    Completed

  • Cognitive Clinical Trials (CCT) - Papillion /ID# 248536

    Papillion, Nebraska, 68046-4131

    Completed

  • Children's Hospital of Philadelphia - Main /ID# 258071

    Philadelphia, Pennsylvania, 19104-4319

    Recruiting

  • Proven Endpoints LLC /ID# 258066

    Ridgeland, Mississippi, 39157

    Site Coordinator, 601-790-1811

    Recruiting

  • Highland Clinical Research /ID# 247590

    Salt Lake City, Utah, 84124

    Recruiting

  • Lumos Clinical Research Center /ID# 249731

    San Jose, California, 95124-4108

    Recruiting

  • The Center for Clinical Trials - Saraland /ID# 271604

    Saraland, Alabama, 36571

    Recruiting

  • FWD Clinical Research - Spring Hill /ID# 248525

    Spring Hill, Florida, 34609-5692

    Completed

  • Family Psychiatry of The Woodlands /ID# 249727

    The Woodlands, Texas, 77381

    Completed

  • Sunwise Clinical Research /ID# 248529

    Walnut Creek, California, 94596

    Recruiting

  • ClinPoint Trials /ID# 248540

    Waxahachie, Texas, 75165-1430

    Recruiting

  • CincyScience /ID# 249726

    West Chester, Ohio, 45069

    Completed

Other trials in United States

Japan7 sites, 7 recruiting

  • Konan Medical Center /ID# 254457

    Kobe, Hyōgo, 658-0064

    Recruiting

  • Umenotsuji Clinic /ID# 254453

    Kochi, Kochi, 780-8011

    Recruiting

  • Tatsuoka Neurology Clinic /ID# 254455

    Kyoto, 600-8811

    Recruiting

  • Yamaguchi Clinic /ID# 254753

    Nishinomiya, Hyōgo, 663-8204

    Recruiting

  • Tominaga Clinic - Osaka /ID# 254450

    Osaka, Osaka, 556-0015

    Recruiting

  • Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211

    Sendai, Miyagi, 982-0014

    Recruiting

  • Tokyo Medical University Hospital /ID# 254459

    Shinjuku-ku, Tokyo, 160-0023

    Recruiting

Other trials in Japan

Poland6 sites, 6 recruiting

  • Athleticomed Sp. z o.o /ID# 248789

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752

    Recruiting

  • Specjalistyczne Gabinety Sp. z o.o. /ID# 247384

    Krakow, Lesser Poland Voivodeship, 30-539

    Recruiting

  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247382

    Lublin, Lublin Voivodeship, 20-582

    Recruiting

  • Clinical Research Center Medic-R /ID# 247383

    Poznan, Greater Poland Voivodeship, 60-848

    Recruiting

  • Oha-Med Sp. Z O.O /ID# 248614

    Warsaw, Masovian Voivodeship, 01-018

    Recruiting

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 247381

    Wroclaw, 52-210

    Recruiting

Other trials in Poland

Israel5 sites, 4 recruiting

  • Shamir Medical Center /ID# 256857

    Beer Ya'akov, Central District, 70300

    Recruiting

  • Hillel Yaffe Medical Center /ID# 246747

    Hadera, Haifa District, 38100

    Completed

  • Bnai Zion Medical Center /ID# 247469

    Haifa, 3339419

    Recruiting

  • The Chaim Sheba Medical Center /ID# 246746

    Ramat Gan, Tel Aviv, 5265601

    Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 247466

    Tel Aviv, Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Puerto Rico5 sites, 1 recruiting

  • Clinical Research Investigator Group /ID# 261254

    Bayamón, 00960

    Completed

  • Dr. Samuel Sanchez PSC /ID# 248495

    Caguas, 00727

    Completed

  • Puerto Rico Health Institute /ID# 249741

    Dorado, 00646

    Site Coordinator, 787-797-1049

    Recruiting

  • Caribbean Medical Research Center Headlands /ID# 251634

    San Juan, 00918-3501

    Completed

  • PRCCI Clinical Research Center /ID# 262726

    San Juan, 00927

    Completed

Other trials in Puerto Rico

Spain5 sites, 3 recruiting

  • Hospital Universitario Vall de Hebron /ID# 247967

    Barcelona, 08035

    Recruiting

  • Hospital Clinico San Carlos /ID# 249267

    Madrid, 28040

    Recruiting

  • Hospital Universitario 12 de Octubre /ID# 275578

    Madrid, 28041

    Recruiting

  • Hospital Universitario Virgen del Rocio /ID# 248632

    Seville, 41013

    Completed

  • Hospital Universitario y Politecnico La Fe /ID# 247969

    Valencia, 46026

    Completed

Other trials in Spain

United Kingdom4 sites, 4 recruiting

  • NHS Grampian /ID# 249067

    Aberdeen, AB15 6RE

    Recruiting

  • Medway NHS Foundation Trust /ID# 249065

    Gillingham, Kent, ME7 5NY

    Recruiting

  • Great Ormond Street Children's Hospital /ID# 262933

    London, Greater London, WC1N 3HZ

    Recruiting

  • Stepping Hill Hospital-Stockport NHS foundation trust /ID# 261121

    Stockport, SK2 7JE

    Recruiting

Other trials in United Kingdom

Canada3 sites, 2 recruiting

  • Stollery Children's Hospital /ID# 249672

    Edmonton, Alberta, T6G 2B7

    Recruiting

  • London Health Sciences Center- University Hospital /ID# 252979

    London, Ontario, N6A 5W9

    Recruiting

  • McGill University Health Centre - Glen Site /ID# 247271

    Montreal, Quebec, H4A 3J1

    Completed

Other trials in Canada

Denmark3 sites, 2 recruiting

  • Aalborg Sygehus Nord /ID# 247428

    Aalborg, North Denmark, 9000

    Completed

  • Herlev Hospital /ID# 247724

    Herlev, Capital Region, 2730

    Recruiting

  • Regionshospitalet Godstrup /ID# 247902

    Herning, Central Jutland, 7400

    Site Coordinator, +45 50935730

    Recruiting

Other trials in Denmark

France3 sites

  • CHU Amiens-Picardie Site Sud /ID# 248833

    Amiens, Somme, 80054

    Completed

  • Centre Hosp Intercommunal de Creteil /ID# 248832

    Créteil, Val-de-Marne, 94000

    Completed

  • CHU Toulouse - Hôpital des enfants /ID# 247553

    Toulouse, 31059

    Completed

Other trials in France

Italy3 sites, 3 recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581

    Milan, Milano, 20133

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 247638

    Palermo, 90127

    Recruiting

  • Ospedale Pediatrico Bambino Gesu /ID# 247647

    Rome, Roma, 00165

    Recruiting

Other trials in Italy

Netherlands3 sites, 3 recruiting

  • Canisius-Wilhelmina Ziekenhuis /ID# 253065

    Nijmegen, Gelderland, 6532 SZ

    Recruiting

  • ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301

    Terneuzen, Zeeland, 4535 PA

    Recruiting

  • HagaZiekenhuis /ID# 247318

    The Hague, South Holland, 2545 AA

    Recruiting

Other trials in Netherlands

Romania3 sites

  • Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 248431

    Bucharest, Bucharest, 022102

    Completed

  • Delta Health Care S.R.L /ID# 248130

    Bucharest, 014146

    Completed

  • Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 248595

    Cluj-Napoca, Cluj, 400012

    Completed

Other trials in Romania

Belgium2 sites, 2 recruiting

  • Algemeen Ziekenhuis Sint-Jan Brugge /ID# 247201

    Bruges, West-Vlaanderen, 8000

    Recruiting

  • Uza /Id# 247339

    Edegem, Antwerpen, 2650

    Recruiting

Other trials in Belgium

Hungary2 sites, 1 recruiting

  • MIND Clinic /ID# 248687

    Budapest, 1024

    Completed

  • Semmelweis Egyetem /ID# 248360

    Budapest, 1085

    Recruiting

Other trials in Hungary

Sweden2 sites, 2 recruiting

  • Vastra Gotealandsregionen Regionhalsan /ID# 248277

    Mölnlycke, 435 30

    Recruiting

  • Sodersjukhuset /ID# 248279

    Stockholm, Stockholm County, 118 83

    Recruiting

Other trials in Sweden

About this study

Official title: A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17.

Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide.

Read more

Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks.

There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Being tested
Atogepant, Placebo-Matching Atogepant
Keywords
Episodic Migraine, Atogepant, QULIPTA, AGN-241689

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtogepantDrug

    Also called QULIPTA, AGN-241689

    Oral Tablet

  • Placebo-Matching AtogepantDrug

    Oral Tablet

Study groups in NCT05711394
Study groupRoleWhat they receive
Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)ExperimentalParticipants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
Receives: Drug: Atogepant
Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)ExperimentalParticipants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
Receives: Drug: Atogepant
Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)ExperimentalParticipants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Receives: Drug: Atogepant
Double-Blind Treatment Period: Placebo (12-17 yrs)Placebo comparatorParticipants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Receives: Drug: Placebo-Matching Atogepant
Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)ExperimentalParticipants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Receives: Drug: Atogepant
Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)ExperimentalParticipants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Receives: Drug: Atogepant
Double-Blind Treatment Period: Placebo (6-11 yrs)Placebo comparatorParticipants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Receives: Drug: Placebo-Matching Atogepant
Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)ExperimentalParticipants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Receives: Drug: Atogepant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Mean Monthly Migraine Days

    A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.

    Measured: Baseline (Week 0) through Week 12

  2. Number of Participants Experiencing Adverse Events

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Baseline (Week 0) through Week 16

Secondary outcomes (6)

  1. Change from Baseline in Mean Monthly Headache Days

    A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM.

    Measured: Baseline (Week 0) through Week 12

  2. Change from Baseline in Mean Monthly Headache Days of at Least Moderate Severity

    A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM.

    Measured: Baseline (Week 0) through Week 12

  3. Change from Baseline in Mean Monthly Acute Medication Use Days

    An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.

    Measured: Baseline (Week 0) through Week 12

  4. Percentage of Participants who Achieve at least a 50% Reduction in Average of Monthly Migraine Days

    A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.

    Measured: Baseline (Week 0) to 3 Months

  5. Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) total score

    The PedsQL is a 23-item measure that evaluates quality of life in four areas of functioning: physical, emotional, social, and school functioning. The PedsQL yields a total quality of life score and two summary scores: Physical Health Summary Score and Psychosocial Health Summary Score.

    Measured: Baseline (Week 0) through Week 12

  6. Change from baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) total score

    The PedMIDAS scale evaluates the impact of headache on school performance, disability at home and social/sport function. The score is a composite of the total of 6 questions.

    Measured: Baseline (Week 0) through Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2023
  2. Study start1 May 2023
  3. Primary completionMar 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05711394
Sponsor's protocol ID
M21-201
Other IDs
2022-501100-94-00
Status last verified
Oct 2026
First submitted
26 Jan 2023
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Publications

  • Shin L, Mentz O, Gelfand AA, de Prado BM, Shapiro H, Oh A, Onifade OO, Saunders J, Raj N, Szperka CL. Gepants for headache prevention in children and adolescents: A multicenter chart review study. Headache. 2026 Jan;66(1):239-248. doi: 10.1111/head.15087. Epub 2025 Nov 14.

    PubMed 41235617

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atogepant in people with Episodic Migraine, run by AbbVie at 98 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States, Japan, Poland, Israel, Puerto Rico and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Mean Monthly Migraine Days (time frame: Baseline (Week 0) through Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05711394, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in