En undersøgelse af orale atogepant -tabletter til vurdering af bivirkninger og ændring i sygdomsaktivitet for at forhindre migræne hos deltagere i alderen 12 til 17 år
En fase 3, multicenter, 12-ugers, dobbeltblind, placebokontrolleret undersøgelse for at evaluere sikkerheden og effektiviteten af atogepant til forebyggende behandling af kronisk migræne hos pædiatriske personer 12 til 17 år gammel.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Studiesteder
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Ontario
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London, Ontario, Canada, N6A 5W9
- Rekruttering
- London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- Afsluttet
- McGill University Health Centre - Glen Site /ID# 270662
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Capital Region
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Herlev, Capital Region, Danmark, 2730
- Rekruttering
- Herlev Hospital /ID# 270482
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Central Jutland
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Herning, Central Jutland, Danmark, 7400
- Rekruttering
- Regionshospitalet Godstrup /ID# 270481
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Stockport, Det Forenede Kongerige, SK2 7JE
- Rekruttering
- Stepping Hill Hospital-Stockport NHS foundation trust /ID# 271883
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Greater London
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London, Greater London, Det Forenede Kongerige, WC1N 3HZ
- Rekruttering
- Great Ormond Street Children's Hospital /ID# 271550
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Kent
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Gillingham, Kent, Det Forenede Kongerige, ME7 5NY
- Rekruttering
- Medway Maritime Hospital /ID# 271885
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Scotland
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Aberdeen, Scotland, Det Forenede Kongerige, AB25 2ZG
- Rekruttering
- Royal Aberdeen Children's Hospital /ID# 271664
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West Yorkshire
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Leeds, West Yorkshire, Det Forenede Kongerige, LS9 7TF
- Rekruttering
- Leeds Teaching Hospitals NHS Trust /ID# 273449
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Alabama
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Huntsville, Alabama, Forenede Stater, 35805
- Rekruttering
- Rehabilitation and Neurological Services /ID# 270782
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Arkansas
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Fayetteville, Arkansas, Forenede Stater, 72703
- Afsluttet
- Preferred Research Partners - Fayetteville /ID# 270419
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Little Rock, Arkansas, Forenede Stater, 72211
- Rekruttering
- Preferred Research Partners /ID# 270389
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California
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Anaheim, California, Forenede Stater, 92805
- Rekruttering
- Advanced Research Center /ID# 270257
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Fresno, California, Forenede Stater, 93710
- Rekruttering
- Neuro Pain Research Center /ID# 271048
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Long Beach, California, Forenede Stater, 90807
- Rekruttering
- Alliance for Research Alliance for Wellness /ID# 270398
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Oceanside, California, Forenede Stater, 92056
- Rekruttering
- Excell Research /ID# 270258
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San Jose, California, Forenede Stater, 95124
- Rekruttering
- Lumos Clinical Research Center /ID# 270582
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Walnut Creek, California, Forenede Stater, 94596
- Rekruttering
- Sunwise Clinical Research /ID# 270431
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Florida
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Gulf Breeze, Florida, Forenede Stater, 32561
- Rekruttering
- Northwest Florida Clinical Research Group, LLC /ID# 270833
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Lakeland, Florida, Forenede Stater, 33813
- Afsluttet
- Auzmer Research /ID# 271158
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Miami, Florida, Forenede Stater, 33155
- Rekruttering
- My Preferred Research /ID# 270312
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Weston, Florida, Forenede Stater, 33331
- Rekruttering
- Encore Medical Research - Weston /ID# 271139
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Winter Park, Florida, Forenede Stater, 32789
- Rekruttering
- Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263
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Indiana
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Evansville, Indiana, Forenede Stater, 47710
- Rekruttering
- Deaconess Midtown Hospital /ID# 270572
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48104
- Rekruttering
- Michigan Headache & Neurological Institute /ID# 270942
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Mississippi
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Ridgeland, Mississippi, Forenede Stater, 39157
- Rekruttering
- Proven Endpoints LLC /ID# 270269
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Nebraska
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Papillion, Nebraska, Forenede Stater, 68046
- Rekruttering
- Cct Research - Papillion Research Center /ID# 270393
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New Hampshire
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Nashua, New Hampshire, Forenede Stater, 03060
- Rekruttering
- Healthy Perspectives - Innovate Mental Health Services /ID# 270847
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New York
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Amherst, New York, Forenede Stater, 14226
- Rekruttering
- Dent Neurologic Institute - Amherst /ID# 270260
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North Carolina
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Greensboro, North Carolina, Forenede Stater, 27405
- Afsluttet
- Headache Wellness Center /ID# 270568
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- The Children's Hospital of Philadelphia /ID# 270842
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Scottdale, Pennsylvania, Forenede Stater, 15683
- Rekruttering
- Frontier Clinical Research - Scottdale /ID# 270854
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Smithfield, Pennsylvania, Forenede Stater, 15478
- Rekruttering
- Frontier Clinical Research - Smithfield /ID# 270849
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Access Clinical Trials Inc /ID# 270280
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Texas
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Austin, Texas, Forenede Stater, 78723-3079
- Rekruttering
- UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577
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Houston, Texas, Forenede Stater, 77058
- Rekruttering
- Earle Research /ID# 270424
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Waxahachie, Texas, Forenede Stater, 75165
- Rekruttering
- Clinpoint Trials /ID# 270261
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Utah
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Bountiful, Utah, Forenede Stater, 84010
- Rekruttering
- Pantheon Clinical Research /ID# 270259
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Clinton, Utah, Forenede Stater, 84015
- Rekruttering
- Alpine Research Organization - Clinton /ID# 276527
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Salt Lake City, Utah, Forenede Stater, 84124
- Rekruttering
- Highland Clinical Research /ID# 270281
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West Virginia
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Kingwood, West Virginia, Forenede Stater, 26537
- Rekruttering
- Frontier Clinical Research - Kingwood /ID# 271053
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Gelderland
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Nijmegen, Gelderland, Holland, 6532 SZ
- Rekruttering
- Canisius-Wilhelmina Ziekenhuis /ID# 270374
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South Holland
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The Hague, South Holland, Holland, 2545 AA
- Rekruttering
- HagaZiekenhuis /ID# 270379
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Milano
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Milan, Milano, Italien, 20133
- Rekruttering
- Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756
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Roma
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Rome, Roma, Italien, 00165
- Rekruttering
- Ospedale Pediatrico Bambino Gesu /ID# 270759
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Kagoshima, Japan, 890-0052
- Rekruttering
- Tanaka Neurosurgery & Headache Clinic /ID# 271346
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Hyōgo
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Kobe, Hyōgo, Japan, 658-0064
- Rekruttering
- Konan Medical Center /ID# 270486
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Kochi
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Kochi, Kochi, Japan, 780-8011
- Rekruttering
- Umenotsuji Clinic /ID# 270484
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Osaka
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Osaka, Osaka, Japan, 556-0015
- Rekruttering
- Tominaga Clinic - Osaka /ID# 270483
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Kontakt:
- Site Coordinator
- Telefonnummer: ＋81-6-6643-2660
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Tokyo
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Shibuya-ku, Tokyo, Japan, 151-0051
- Rekruttering
- Tokyo Headache Clinic /ID# 271610
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Shinjuku-ku, Tokyo, Japan, 160-0023
- Rekruttering
- Tokyo Medical University Hospital /ID# 270487
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Yamagata
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Tendo-shi, Yamagata, Japan, 994-0083
- Rekruttering
- Tendo Brain Clinic /ID# 271410
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Yamanashi
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Kai, Yamanashi, Japan, 400-0124
- Rekruttering
- Nagaseki Headache Clinic /ID# 271699
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polen, 60-848
- Rekruttering
- Clinical Research Center Medic-R /ID# 270235
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-752
- Rekruttering
- Athleticomed Sp. z o.o /ID# 270243
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 30-539
- Rekruttering
- Specjalistyczne Gabinety Sp. z o.o /ID# 270238
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polen, 52-210
- Rekruttering
- MIGRE Polskie Centrum Leczenia Migreny /ID# 270239
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 01-018
- Rekruttering
- Oha-Med Sp. Z O.O /ID# 270242
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Coimbra, Portugal, 3000-075
- Rekruttering
- Unidade Local de Saude de Coimbra /ID# 277993
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Lisbon, Portugal, 1649-035
- Rekruttering
- Unidade Local de Saude de Santa Maria /ID# 277997
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Porto, Portugal, 4099-003
- Rekruttering
- Unidade Local de Saude de Santo Antonio /ID# 278090
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Lisbon District
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Lisbon, Lisbon District, Portugal, 1500-650
- Rekruttering
- Hospital da Luz /ID# 277991
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Setúbal District
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Almada, Setúbal District, Portugal, 2805-267
- Rekruttering
- Unidade Local de Saude de Almada-Seixal, EPE /ID# 278092
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Kontakt:
- Site Coordinator
- Telefonnummer: 351 21 294 0294
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San Juan, Puerto Rico, 00918-3501
- Afsluttet
- Caribbean Medical Research Center Headlands /ID# 271300
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Budapest, Ungarn, 1085
- Rekruttering
- Semmelweis Egyetem /ID# 271219
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Budapest, Ungarn, 1141
- Rekruttering
- Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
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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.
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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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Atogepant
Participants will receive atogepant once daily for 12 weeks. |
Oral tablet
Andre navne:
|
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Placebo komparator: Placebo for Atogepant
Participants will receive placebo for atogepant once daily for 12 weeks. |
Oral tablet |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
Tidsramme: Up to approximately 16 weeks
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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
|
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Change From Baseline in Mean Monthly Migraine Days
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Mean Monthly Headache Days
Tidsramme: 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
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Change From Baseline in Mean Monthly Acute Medication Use Days
Tidsramme: Baseline (Week 0) through Week 12
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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
|
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Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days
Tidsramme: 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
|
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Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score
Tidsramme: 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
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Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: ABBVIE INC., AbbVie
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- M23-712
- 2024-513836-28-00 (Ctis)
- 2024-513836-28
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
IPD-delingstidsramme
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD-delingsadgangskriterier
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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