Uno studio delle compresse di atogepant orale per valutare gli eventi avversi e il cambiamento dell'attività della malattia per prevenire l'emicrania nei partecipanti dai 12 ai 17 anni
Un studio di fase 3, multicentrico, 12 settimane, doppio cieco, controllato con placebo per valutare la sicurezza e l'efficacia di Atogepant per il trattamento preventivo dell'emicrania cronica in soggetti pediatrici di età compresa tra 12 e 17 anni
Migraine is a disease that most often causes 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. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age.
Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world.
Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks.
Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: ABBVIE CALL CENTER
- Numero di telefono: 844-663-3742
- Email: abbvieclinicaltrials@abbvie.com
Luoghi di studio
-
-
Ontario
-
London, Ontario, Canada, N6A 5W9
- Reclutamento
- London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659
-
-
Quebec
-
Montreal, Quebec, Canada, H4A 3J1
- Completato
- McGill University Health Centre - Glen Site /ID# 270662
-
-
-
-
Capital Region
-
Herlev, Capital Region, Danimarca, 2730
- Reclutamento
- Herlev Hospital /ID# 270482
-
-
Central Jutland
-
Herning, Central Jutland, Danimarca, 7400
- Reclutamento
- Regionshospitalet Godstrup /ID# 270481
-
-
-
-
-
Kagoshima, Giappone, 890-0052
- Reclutamento
- Tanaka Neurosurgery & Headache Clinic /ID# 271346
-
-
Hyōgo
-
Kobe, Hyōgo, Giappone, 658-0064
- Reclutamento
- Konan Medical Center /ID# 270486
-
-
Kochi
-
Kochi, Kochi, Giappone, 780-8011
- Reclutamento
- Umenotsuji Clinic /ID# 270484
-
-
Osaka
-
Osaka, Osaka, Giappone, 556-0015
- Reclutamento
- Tominaga Clinic - Osaka /ID# 270483
-
Contatto:
- Site Coordinator
- Numero di telefono: ＋81-6-6643-2660
-
-
Tokyo
-
Shibuya-ku, Tokyo, Giappone, 151-0051
- Reclutamento
- Tokyo Headache Clinic /ID# 271610
-
Shinjuku-ku, Tokyo, Giappone, 160-0023
- Reclutamento
- Tokyo Medical University Hospital /ID# 270487
-
-
Yamagata
-
Tendo-shi, Yamagata, Giappone, 994-0083
- Reclutamento
- Tendo Brain Clinic /ID# 271410
-
-
Yamanashi
-
Kai, Yamanashi, Giappone, 400-0124
- Reclutamento
- Nagaseki Headache Clinic /ID# 271699
-
-
-
-
Milano
-
Milan, Milano, Italia, 20133
- Reclutamento
- Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756
-
-
Roma
-
Rome, Roma, Italia, 00165
- Reclutamento
- Ospedale Pediatrico Bambino Gesu /ID# 270759
-
-
-
-
Gelderland
-
Nijmegen, Gelderland, Olanda, 6532 SZ
- Reclutamento
- Canisius-Wilhelmina Ziekenhuis /ID# 270374
-
-
South Holland
-
The Hague, South Holland, Olanda, 2545 AA
- Reclutamento
- HagaZiekenhuis /ID# 270379
-
-
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polonia, 60-848
- Reclutamento
- Clinical Research Center Medic-R /ID# 270235
-
-
Kuyavian-Pomeranian Voivodeship
-
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polonia, 85-752
- Reclutamento
- Athleticomed Sp. z o.o /ID# 270243
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, Polonia, 30-539
- Reclutamento
- Specjalistyczne Gabinety Sp. z o.o /ID# 270238
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Polonia, 52-210
- Reclutamento
- MIGRE Polskie Centrum Leczenia Migreny /ID# 270239
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polonia, 01-018
- Reclutamento
- Oha-Med Sp. Z O.O /ID# 270242
-
-
-
-
-
San Juan, Porto Rico, 00918-3501
- Completato
- Caribbean Medical Research Center Headlands /ID# 271300
-
-
-
-
-
Coimbra, Portogallo, 3000-075
- Reclutamento
- Unidade Local de Saude de Coimbra /ID# 277993
-
Lisbon, Portogallo, 1649-035
- Reclutamento
- Unidade Local de Saude de Santa Maria /ID# 277997
-
Porto, Portogallo, 4099-003
- Reclutamento
- Unidade Local de Saude de Santo Antonio /ID# 278090
-
-
Lisbon District
-
Lisbon, Lisbon District, Portogallo, 1500-650
- Reclutamento
- Hospital da Luz /ID# 277991
-
-
Setúbal District
-
Almada, Setúbal District, Portogallo, 2805-267
- Reclutamento
- Unidade Local de Saude de Almada-Seixal, EPE /ID# 278092
-
Contatto:
- Site Coordinator
- Numero di telefono: 351 21 294 0294
-
-
-
-
-
Stockport, Regno Unito, SK2 7JE
- Reclutamento
- Stepping Hill Hospital-Stockport NHS foundation trust /ID# 271883
-
-
Greater London
-
London, Greater London, Regno Unito, WC1N 3HZ
- Reclutamento
- Great Ormond Street Children's Hospital /ID# 271550
-
-
Kent
-
Gillingham, Kent, Regno Unito, ME7 5NY
- Reclutamento
- Medway Maritime Hospital /ID# 271885
-
-
Scotland
-
Aberdeen, Scotland, Regno Unito, AB25 2ZG
- Reclutamento
- Royal Aberdeen Children's Hospital /ID# 271664
-
-
West Yorkshire
-
Leeds, West Yorkshire, Regno Unito, LS9 7TF
- Reclutamento
- Leeds Teaching Hospitals NHS Trust /ID# 273449
-
-
-
-
Alabama
-
Huntsville, Alabama, Stati Uniti, 35805
- Reclutamento
- Rehabilitation and Neurological Services /ID# 270782
-
-
Arkansas
-
Fayetteville, Arkansas, Stati Uniti, 72703
- Completato
- Preferred Research Partners - Fayetteville /ID# 270419
-
Little Rock, Arkansas, Stati Uniti, 72211
- Reclutamento
- Preferred Research Partners /ID# 270389
-
-
California
-
Anaheim, California, Stati Uniti, 92805
- Reclutamento
- Advanced Research Center /ID# 270257
-
Fresno, California, Stati Uniti, 93710
- Reclutamento
- Neuro Pain Research Center /ID# 271048
-
Long Beach, California, Stati Uniti, 90807
- Reclutamento
- Alliance for Research Alliance for Wellness /ID# 270398
-
Oceanside, California, Stati Uniti, 92056
- Reclutamento
- Excell Research /ID# 270258
-
San Jose, California, Stati Uniti, 95124
- Reclutamento
- Lumos Clinical Research Center /ID# 270582
-
Walnut Creek, California, Stati Uniti, 94596
- Reclutamento
- Sunwise Clinical Research /ID# 270431
-
-
Florida
-
Gulf Breeze, Florida, Stati Uniti, 32561
- Reclutamento
- Northwest Florida Clinical Research Group, LLC /ID# 270833
-
Lakeland, Florida, Stati Uniti, 33813
- Completato
- Auzmer Research /ID# 271158
-
Miami, Florida, Stati Uniti, 33155
- Reclutamento
- My Preferred Research /ID# 270312
-
Weston, Florida, Stati Uniti, 33331
- Reclutamento
- Encore Medical Research - Weston /ID# 271139
-
Winter Park, Florida, Stati Uniti, 32789
- Reclutamento
- Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263
-
-
Indiana
-
Evansville, Indiana, Stati Uniti, 47710
- Reclutamento
- Deaconess Midtown Hospital /ID# 270572
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48104
- Reclutamento
- Michigan Headache & Neurological Institute /ID# 270942
-
-
Mississippi
-
Ridgeland, Mississippi, Stati Uniti, 39157
- Reclutamento
- Proven Endpoints LLC /ID# 270269
-
-
Nebraska
-
Papillion, Nebraska, Stati Uniti, 68046
- Reclutamento
- Cct Research - Papillion Research Center /ID# 270393
-
-
New Hampshire
-
Nashua, New Hampshire, Stati Uniti, 03060
- Reclutamento
- Healthy Perspectives - Innovate Mental Health Services /ID# 270847
-
-
New York
-
Amherst, New York, Stati Uniti, 14226
- Reclutamento
- Dent Neurologic Institute - Amherst /ID# 270260
-
-
North Carolina
-
Greensboro, North Carolina, Stati Uniti, 27405
- Completato
- Headache Wellness Center /ID# 270568
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19104
- Reclutamento
- The Children's Hospital of Philadelphia /ID# 270842
-
Scottdale, Pennsylvania, Stati Uniti, 15683
- Reclutamento
- Frontier Clinical Research - Scottdale /ID# 270854
-
Smithfield, Pennsylvania, Stati Uniti, 15478
- Reclutamento
- Frontier Clinical Research - Smithfield /ID# 270849
-
-
Tennessee
-
Nashville, Tennessee, Stati Uniti, 37203
- Reclutamento
- Access Clinical Trials Inc /ID# 270280
-
-
Texas
-
Austin, Texas, Stati Uniti, 78723-3079
- Reclutamento
- UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577
-
Houston, Texas, Stati Uniti, 77058
- Reclutamento
- Earle Research /ID# 270424
-
Waxahachie, Texas, Stati Uniti, 75165
- Reclutamento
- Clinpoint Trials /ID# 270261
-
-
Utah
-
Bountiful, Utah, Stati Uniti, 84010
- Reclutamento
- Pantheon Clinical Research /ID# 270259
-
Clinton, Utah, Stati Uniti, 84015
- Reclutamento
- Alpine Research Organization - Clinton /ID# 276527
-
Salt Lake City, Utah, Stati Uniti, 84124
- Reclutamento
- Highland Clinical Research /ID# 270281
-
-
West Virginia
-
Kingwood, West Virginia, Stati Uniti, 26537
- Reclutamento
- Frontier Clinical Research - Kingwood /ID# 271053
-
-
-
-
-
Budapest, Ungheria, 1085
- Reclutamento
- Semmelweis Egyetem /ID# 271219
-
Budapest, Ungheria, 1141
- Reclutamento
- Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
-
History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1.
-
During the last 28 days of the screening/baseline period, and as per eDiary:
- Participant must have completed the eDiary for a minimum of 20 out of 28 days.
- Participant has >= 15 headache days.
- Participant has >= 8 migraine days.
Exclusion Criteria:
- Clinically significant hypertension per investigator's judgment.
- History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Atogepant
Participants will receive atogepant once daily for 12 weeks. |
Oral tablet
Altri nomi:
|
|
Comparatore placebo: Placebo for Atogepant
Participants will receive placebo for atogepant once daily for 12 weeks. |
Oral tablet |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
Lasso di tempo: Up to approximately 16 weeks
|
An adverse event (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. |
Up to approximately 16 weeks
|
|
Change From Baseline in Mean Monthly Migraine Days
Lasso di tempo: Baseline (Week 0) through Week 12
|
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary. |
Baseline (Week 0) through Week 12
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Mean Monthly Headache Days
Lasso di tempo: Baseline (Week 0) through Week 12
|
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. |
Baseline (Week 0) through Week 12
|
|
Change From Baseline in Mean Monthly Acute Medication Use Days
Lasso di tempo: Baseline (Week 0) through Week 12
|
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. |
Baseline (Week 0) through Week 12
|
|
Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days
Lasso di tempo: Baseline (Week 0) through Week 12
|
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. |
Baseline (Week 0) through Week 12
|
|
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score
Lasso di tempo: Baseline (Week 0) through Week 12
|
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. |
Baseline (Week 0) through Week 12
|
|
Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score
Lasso di tempo: Baseline (Week 0) through Week 12
|
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. |
Baseline (Week 0) through Week 12
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: ABBVIE INC., AbbVie
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- M23-712
- 2024-513836-28-00 (Ctis)
- 2024-513836-28
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Periodo di condivisione IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Criteri di accesso alla condivisione IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .