Un estudio para evaluar los eventos adversos y el cambio en la actividad de la enfermedad de las tabletas orales de atogepant en participantes pediátricos (6 a 17 años de edad) con migraña episódica
Un estudio de fase 3, multicéntrico, de 12 semanas, doble ciego, controlado con placebo para evaluar la seguridad y eficacia de atogepant para el tratamiento preventivo de la migraña episódica en sujetos pediátricos de 6 a 17 años de edad.
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.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ABBVIE CALL CENTER
- Número de teléfono: 844-663-3742
- Correo electrónico: abbvieclinicaltrials@abbvie.com
Ubicaciones de estudio
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Antwerpen
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Edegem, Antwerpen, Bélgica, 2650
- Reclutamiento
- Uza /Id# 247339
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West-Vlaanderen
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Bruges, West-Vlaanderen, Bélgica, 8000
- Reclutamiento
- Algemeen Ziekenhuis Sint-Jan Brugge /ID# 247201
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Alberta
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Edmonton, Alberta, Canadá, T6G 2B7
- Reclutamiento
- Stollery Children's Hospital /ID# 249672
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Ontario
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London, Ontario, Canadá, N6A 5W9
- Reclutamiento
- London Health Sciences Center- University Hospital /ID# 252979
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Quebec
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Montreal, Quebec, Canadá, H4A 3J1
- Terminado
- McGill University Health Centre - Glen Site /ID# 247271
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Capital Region
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Herlev, Capital Region, Dinamarca, 2730
- Reclutamiento
- Herlev Hospital /ID# 247724
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Central Jutland
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Herning, Central Jutland, Dinamarca, 7400
- Reclutamiento
- Regionshospitalet Godstrup /ID# 247902
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Contacto:
- Site Coordinator
- Número de teléfono: +45 50935730
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North Denmark
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Aalborg, North Denmark, Dinamarca, 9000
- Terminado
- Aalborg Sygehus Nord /ID# 247428
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Barcelona, España, 08035
- Reclutamiento
- Hospital Universitario Vall de Hebron /ID# 247967
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Madrid, España, 28040
- Reclutamiento
- Hospital Clinico San Carlos /ID# 249267
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Madrid, España, 28041
- Reclutamiento
- Hospital Universitario 12 de Octubre /ID# 275578
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Seville, España, 41013
- Terminado
- Hospital Universitario Virgen del Rocio /ID# 248632
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Valencia, España, 46026
- Terminado
- Hospital Universitario y Politecnico La Fe /ID# 247969
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Alabama
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Huntsville, Alabama, Estados Unidos, 35805-4046
- Reclutamiento
- Rehabilitation & Neurological Services /ID# 248517
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Saraland, Alabama, Estados Unidos, 36571
- Reclutamiento
- The Center for Clinical Trials - Saraland /ID# 271604
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72211
- Reclutamiento
- Preferred Research Partners /ID# 249729
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Little Rock, Arkansas, Estados Unidos, 72211
- Terminado
- Preferred Research Partners /ID# 270406
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California
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Anaheim, California, Estados Unidos, 92805
- Reclutamiento
- Advanced Research Center /ID# 251381
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Long Beach, California, Estados Unidos, 90807
- Reclutamiento
- Alliance for Research Alliance for Wellness /ID# 248521
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Oceanside, California, Estados Unidos, 92056
- Terminado
- Excell Research, Inc /ID# 247532
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San Jose, California, Estados Unidos, 95124-4108
- Reclutamiento
- Lumos Clinical Research Center /ID# 249731
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Walnut Creek, California, Estados Unidos, 94596
- Reclutamiento
- Sunwise Clinical Research /ID# 248529
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Colorado
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Fort Collins, Colorado, Estados Unidos, 80528
- Terminado
- Advanced Neurosciences Research, LLC /ID# 247592
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Florida
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Gulf Breeze, Florida, Estados Unidos, 32561-4495
- Terminado
- Northwest Florida Clinical Research Group, LLC /ID# 251382
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Homestead, Florida, Estados Unidos, 33030-4613
- Terminado
- Advanced Research Institute of Miami /ID# 248539
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Miami, Florida, Estados Unidos, 33155
- Reclutamiento
- My Preferred Research LLC /ID# 249720
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Spring Hill, Florida, Estados Unidos, 34609-5692
- Terminado
- FWD Clinical Research - Spring Hill /ID# 248525
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Georgia
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Brunswick, Georgia, Estados Unidos, 31520-1601
- Reclutamiento
- Coastal Georgia Child Neurology /ID# 249733
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Contacto:
- Site Coordinator
- Número de teléfono: 770-376-7912
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Indiana
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Newburgh, Indiana, Estados Unidos, 47630
- Reclutamiento
- Deaconess Clinic - Gateway Health Center /ID# 247589
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Contacto:
- Site Coordinator
- Número de teléfono: 812-474-7184
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Kansas
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Overland Park, Kansas, Estados Unidos, 66210-2761
- Terminado
- College Park Family Care Center Overland Park /ID# 249734
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48104-5131
- Reclutamiento
- Michigan Headache & Neurological Institute (MHNI) /ID# 247468
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Contacto:
- Site Coordinator
- Número de teléfono: 734-677-6000
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Mississippi
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Ridgeland, Mississippi, Estados Unidos, 39157
- Reclutamiento
- Proven Endpoints LLC /ID# 258066
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Contacto:
- Site Coordinator
- Número de teléfono: 601-790-1811
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Nebraska
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Papillion, Nebraska, Estados Unidos, 68046-4131
- Terminado
- Cognitive Clinical Trials (CCT) - Papillion /ID# 248536
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New Jersey
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Morristown, New Jersey, Estados Unidos, 07960
- Reclutamiento
- Goryeb Childrens Hospital /ID# 249724
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New York
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Amherst, New York, Estados Unidos, 14226
- Reclutamiento
- Dent Neurologic Institute - Amherst /ID# 248534
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Contacto:
- Site Coordinator
- Número de teléfono: 716-558-5670
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New York, New York, Estados Unidos, 10001
- Terminado
- Modern Migraine MD /ID# 258074
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North Carolina
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Greensboro, North Carolina, Estados Unidos, 27405
- Reclutamiento
- Headache Wellness Center /ID# 251018
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45215-2123
- Reclutamiento
- Patient Priority Clinical Sites, LLC /ID# 247535
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Contacto:
- Site Coordinator
- Número de teléfono: 513-791-7760
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Cincinnati, Ohio, Estados Unidos, 45229
- Reclutamiento
- Cincinnati Childrens Hospital Medical Center /ID# 258070
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West Chester, Ohio, Estados Unidos, 45069
- Terminado
- CincyScience /ID# 249726
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73112
- Terminado
- Lynn Institute of Oklahoma City /ID# 247600
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104-4319
- Reclutamiento
- Children's Hospital of Philadelphia - Main /ID# 258071
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38103
- Terminado
- Le Bonheur Children's Hospital /ID# 261084
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- Access Clinical Trials, Inc. /ID# 248532
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Texas
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Austin, Texas, Estados Unidos, 78723-3079
- Reclutamiento
- UT Health Austin at Dell Children's Neurology Clinic /ID# 264082
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Austin, Texas, Estados Unidos, 78731
- Terminado
- FutureSearch Trials of Neurology /ID# 247470
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El Paso, Texas, Estados Unidos, 79925-7945
- Terminado
- 3A Research - East El Paso /ID# 248516
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Friendswood, Texas, Estados Unidos, 77546
- Reclutamiento
- Earle Research /ID# 248501
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Contacto:
- Site Coordinator
- Número de teléfono: 281-218-8080
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The Woodlands, Texas, Estados Unidos, 77381
- Terminado
- Family Psychiatry of The Woodlands /ID# 249727
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Waxahachie, Texas, Estados Unidos, 75165-1430
- Reclutamiento
- ClinPoint Trials /ID# 248540
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Utah
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Bountiful, Utah, Estados Unidos, 84010-4968
- Reclutamiento
- Pantheon Clinical Research /ID# 251601
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Clinton, Utah, Estados Unidos, 84015
- Reclutamiento
- Alpine Research Organization - Clinton /ID# 276497
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Salt Lake City, Utah, Estados Unidos, 84124
- Reclutamiento
- Highland Clinical Research /ID# 247590
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Virginia
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Franklin, Virginia, Estados Unidos, 23851
- Reclutamiento
- Office of Maria Ona /ID# 249738
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Washington
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Everett, Washington, Estados Unidos, 98201
- Terminado
- Core Clinical Research /ID# 249721
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Toulouse, Francia, 31059
- Terminado
- CHU Toulouse - Hôpital des enfants /ID# 247553
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Somme
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Amiens, Somme, Francia, 80054
- Terminado
- CHU Amiens-Picardie Site Sud /ID# 248833
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Val-de-Marne
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Créteil, Val-de-Marne, Francia, 94000
- Terminado
- Centre Hosp Intercommunal de Creteil /ID# 248832
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Budapest, Hungría, 1085
- Reclutamiento
- Semmelweis Egyetem /ID# 248360
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Budapest, Hungría, 1024
- Terminado
- MIND Clinic /ID# 248687
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Haifa, Israel, 3339419
- Reclutamiento
- Bnai Zion Medical Center /ID# 247469
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Central District
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Beer Ya'akov, Central District, Israel, 70300
- Reclutamiento
- Shamir Medical Center /ID# 256857
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Haifa District
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Hadera, Haifa District, Israel, 38100
- Terminado
- Hillel Yaffe Medical Center /ID# 246747
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Tel Aviv
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Ramat Gan, Tel Aviv, Israel, 5265601
- Reclutamiento
- The Chaim Sheba Medical Center /ID# 246746
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Tel Aviv, Tel Aviv, Israel, 6423906
- Reclutamiento
- Tel Aviv Sourasky Medical Center /ID# 247466
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Palermo, Italia, 90127
- Reclutamiento
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 247638
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Milano
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Milan, Milano, Italia, 20133
- Reclutamiento
- Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581
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Roma
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Rome, Roma, Italia, 00165
- Reclutamiento
- Ospedale Pediatrico Bambino Gesu /ID# 247647
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Kyoto, Japón, 600-8811
- Reclutamiento
- Tatsuoka Neurology Clinic /ID# 254455
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Hyōgo
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Kobe, Hyōgo, Japón, 658-0064
- Reclutamiento
- Konan Medical Center /ID# 254457
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Nishinomiya, Hyōgo, Japón, 663-8204
- Reclutamiento
- Yamaguchi Clinic /ID# 254753
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Kochi
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Kochi, Kochi, Japón, 780-8011
- Reclutamiento
- Umenotsuji Clinic /ID# 254453
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Miyagi
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Sendai, Miyagi, Japón, 982-0014
- Reclutamiento
- Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211
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Osaka
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Osaka, Osaka, Japón, 556-0015
- Reclutamiento
- Tominaga Clinic - Osaka /ID# 254450
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Tokyo
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Shinjuku-ku, Tokyo, Japón, 160-0023
- Reclutamiento
- Tokyo Medical University Hospital /ID# 254459
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Gelderland
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Nijmegen, Gelderland, Países Bajos, 6532 SZ
- Reclutamiento
- Canisius-Wilhelmina Ziekenhuis /ID# 253065
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South Holland
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The Hague, South Holland, Países Bajos, 2545 AA
- Reclutamiento
- HagaZiekenhuis /ID# 247318
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Zeeland
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Terneuzen, Zeeland, Países Bajos, 4535 PA
- Reclutamiento
- ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301
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Wroclaw, Polonia, 52-210
- Reclutamiento
- MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 247381
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polonia, 60-848
- Reclutamiento
- Clinical Research Center Medic-R /ID# 247383
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polonia, 85-752
- Reclutamiento
- Athleticomed Sp. z o.o /ID# 248789
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polonia, 30-539
- Reclutamiento
- Specjalistyczne Gabinety Sp. z o.o. /ID# 247384
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polonia, 20-582
- Reclutamiento
- Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247382
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polonia, 01-018
- Reclutamiento
- Oha-Med Sp. Z O.O /ID# 248614
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Bayamón, Puerto Rico, 00960
- Terminado
- Clinical Research Investigator Group /ID# 261254
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Caguas, Puerto Rico, 00727
- Terminado
- Dr. Samuel Sanchez PSC /ID# 248495
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Dorado, Puerto Rico, 00646
- Reclutamiento
- Puerto Rico Health Institute /ID# 249741
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Contacto:
- Site Coordinator
- Número de teléfono: 787-797-1049
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San Juan, Puerto Rico, 00927
- Terminado
- PRCCI Clinical Research Center /ID# 262726
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San Juan, Puerto Rico, 00918-3501
- Terminado
- Caribbean Medical Research Center Headlands /ID# 251634
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Aberdeen, Reino Unido, AB15 6RE
- Reclutamiento
- NHS Grampian /ID# 249067
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Stockport, Reino Unido, SK2 7JE
- Reclutamiento
- Stepping Hill Hospital-Stockport NHS foundation trust /ID# 261121
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Greater London
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London, Greater London, Reino Unido, WC1N 3HZ
- Reclutamiento
- Great Ormond Street Children's Hospital /ID# 262933
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Kent
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Gillingham, Kent, Reino Unido, ME7 5NY
- Reclutamiento
- Medway NHS Foundation Trust /ID# 249065
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Bucharest, Rumania, 014146
- Terminado
- Delta Health Care S.R.L /ID# 248130
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Bucharest
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Bucharest, Bucharest, Rumania, 022102
- Terminado
- Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 248431
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Cluj
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Cluj-Napoca, Cluj, Rumania, 400012
- Terminado
- Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 248595
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Mölnlycke, Suecia, 435 30
- Reclutamiento
- Vastra Gotealandsregionen Regionhalsan /ID# 248277
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Stockholm County
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Stockholm, Stockholm County, Suecia, 118 83
- Reclutamiento
- Sodersjukhuset /ID# 248279
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)
Participants 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. |
Oral Tablet
Otros nombres:
|
|
Experimental: Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)
Participants 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. |
Oral Tablet
Otros nombres:
|
|
Experimental: Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)
Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks. |
Oral Tablet
Otros nombres:
|
|
Comparador de placebos: Double-Blind Treatment Period: Placebo (12-17 yrs)
Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks. |
Oral Tablet |
|
Experimental: Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)
Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks. |
Oral Tablet
Otros nombres:
|
|
Experimental: Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)
Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks. |
Oral Tablet
Otros nombres:
|
|
Comparador de placebos: Double-Blind Treatment Period: Placebo (6-11 yrs)
Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks. |
Oral Tablet |
|
Experimental: Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)
Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks. |
Oral Tablet
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in Mean Monthly Migraine Days
Periodo de tiempo: 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
|
|
Number of Participants Experiencing Adverse Events
Periodo de tiempo: Baseline (Week 0) through Week 16
|
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. |
Baseline (Week 0) through Week 16
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in Mean Monthly Headache Days
Periodo de tiempo: 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 Headache Days of at Least Moderate Severity
Periodo de tiempo: 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
Periodo de tiempo: 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 Average of Monthly Migraine Days
Periodo de tiempo: Baseline (Week 0) to 3 Months
|
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) to 3 Months
|
|
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) total score
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: ABBVIE INC., AbbVie
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M21-201
- 2022-501100-94-00 (Otro identificador: EU CT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Criterios de acceso compartido de IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .