Uno studio per valutare gli eventi avversi e il cambiamento nell'attività della malattia delle compresse orali di atogepant nei partecipanti pediatrici (6-17 anni di età) con emicrania episodica
Uno studio di fase 3, multicentrico, di 12 settimane, in doppio cieco, controllato con placebo per valutare la sicurezza e l'efficacia di Atogepant per il trattamento preventivo dell'emicrania episodica in soggetti pediatrici di età compresa tra 6 e 17 anni.
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.
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
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Antwerpen
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Edegem, Antwerpen, Belgio, 2650
- Reclutamento
- Uza /Id# 247339
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West-Vlaanderen
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Bruges, West-Vlaanderen, Belgio, 8000
- Reclutamento
- Algemeen Ziekenhuis Sint-Jan Brugge /ID# 247201
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- Reclutamento
- Stollery Children's Hospital /ID# 249672
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Ontario
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London, Ontario, Canada, N6A 5W9
- Reclutamento
- London Health Sciences Center- University Hospital /ID# 252979
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- Completato
- McGill University Health Centre - Glen Site /ID# 247271
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Capital Region
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Herlev, Capital Region, Danimarca, 2730
- Reclutamento
- Herlev Hospital /ID# 247724
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Central Jutland
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Herning, Central Jutland, Danimarca, 7400
- Reclutamento
- Regionshospitalet Godstrup /ID# 247902
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Contatto:
- Site Coordinator
- Numero di telefono: +45 50935730
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North Denmark
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Aalborg, North Denmark, Danimarca, 9000
- Completato
- Aalborg Sygehus Nord /ID# 247428
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Toulouse, Francia, 31059
- Completato
- CHU Toulouse - Hôpital des enfants /ID# 247553
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Somme
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Amiens, Somme, Francia, 80054
- Completato
- CHU Amiens-Picardie Site Sud /ID# 248833
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Val-de-Marne
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Créteil, Val-de-Marne, Francia, 94000
- Completato
- Centre Hosp Intercommunal de Creteil /ID# 248832
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Kyoto, Giappone, 600-8811
- Reclutamento
- Tatsuoka Neurology Clinic /ID# 254455
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Hyōgo
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Kobe, Hyōgo, Giappone, 658-0064
- Reclutamento
- Konan Medical Center /ID# 254457
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Nishinomiya, Hyōgo, Giappone, 663-8204
- Reclutamento
- Yamaguchi Clinic /ID# 254753
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Kochi
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Kochi, Kochi, Giappone, 780-8011
- Reclutamento
- Umenotsuji Clinic /ID# 254453
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Miyagi
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Sendai, Miyagi, Giappone, 982-0014
- Reclutamento
- Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211
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Osaka
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Osaka, Osaka, Giappone, 556-0015
- Reclutamento
- Tominaga Clinic - Osaka /ID# 254450
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Tokyo
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Shinjuku-ku, Tokyo, Giappone, 160-0023
- Reclutamento
- Tokyo Medical University Hospital /ID# 254459
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Haifa, Israele, 3339419
- Reclutamento
- Bnai Zion Medical Center /ID# 247469
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Central District
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Beer Ya'akov, Central District, Israele, 70300
- Reclutamento
- Shamir Medical Center /ID# 256857
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Haifa District
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Hadera, Haifa District, Israele, 38100
- Completato
- Hillel Yaffe Medical Center /ID# 246747
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Tel Aviv
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Ramat Gan, Tel Aviv, Israele, 5265601
- Reclutamento
- The Chaim Sheba Medical Center /ID# 246746
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Tel Aviv, Tel Aviv, Israele, 6423906
- Reclutamento
- Tel Aviv Sourasky Medical Center /ID# 247466
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Palermo, Italia, 90127
- Reclutamento
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 247638
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Milano
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Milan, Milano, Italia, 20133
- Reclutamento
- Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581
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Roma
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Rome, Roma, Italia, 00165
- Reclutamento
- Ospedale Pediatrico Bambino Gesu /ID# 247647
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Gelderland
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Nijmegen, Gelderland, Olanda, 6532 SZ
- Reclutamento
- Canisius-Wilhelmina Ziekenhuis /ID# 253065
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South Holland
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The Hague, South Holland, Olanda, 2545 AA
- Reclutamento
- HagaZiekenhuis /ID# 247318
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Zeeland
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Terneuzen, Zeeland, Olanda, 4535 PA
- Reclutamento
- ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301
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Wroclaw, Polonia, 52-210
- Reclutamento
- 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
- Reclutamento
- 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
- Reclutamento
- 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
- Reclutamento
- Specjalistyczne Gabinety Sp. z o.o. /ID# 247384
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polonia, 20-582
- Reclutamento
- 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
- Reclutamento
- Oha-Med Sp. Z O.O /ID# 248614
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Bayamón, Porto Rico, 00960
- Completato
- Clinical Research Investigator Group /ID# 261254
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Caguas, Porto Rico, 00727
- Completato
- Dr. Samuel Sanchez PSC /ID# 248495
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Dorado, Porto Rico, 00646
- Reclutamento
- Puerto Rico Health Institute /ID# 249741
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Contatto:
- Site Coordinator
- Numero di telefono: 787-797-1049
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San Juan, Porto Rico, 00927
- Completato
- PRCCI Clinical Research Center /ID# 262726
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San Juan, Porto Rico, 00918-3501
- Completato
- Caribbean Medical Research Center Headlands /ID# 251634
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Aberdeen, Regno Unito, AB15 6RE
- Reclutamento
- NHS Grampian /ID# 249067
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Stockport, Regno Unito, SK2 7JE
- Reclutamento
- Stepping Hill Hospital-Stockport NHS foundation trust /ID# 261121
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Greater London
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London, Greater London, Regno Unito, WC1N 3HZ
- Reclutamento
- Great Ormond Street Children's Hospital /ID# 262933
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Kent
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Gillingham, Kent, Regno Unito, ME7 5NY
- Reclutamento
- Medway NHS Foundation Trust /ID# 249065
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Bucharest, Romania, 014146
- Completato
- Delta Health Care S.R.L /ID# 248130
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Bucharest
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Bucharest, Bucharest, Romania, 022102
- Completato
- Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 248431
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Cluj
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Cluj-Napoca, Cluj, Romania, 400012
- Completato
- Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 248595
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Barcelona, Spagna, 08035
- Reclutamento
- Hospital Universitario Vall de Hebron /ID# 247967
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Madrid, Spagna, 28040
- Reclutamento
- Hospital Clinico San Carlos /ID# 249267
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Madrid, Spagna, 28041
- Reclutamento
- Hospital Universitario 12 de Octubre /ID# 275578
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Seville, Spagna, 41013
- Completato
- Hospital Universitario Virgen del Rocio /ID# 248632
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Valencia, Spagna, 46026
- Completato
- Hospital Universitario y Politecnico La Fe /ID# 247969
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Alabama
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Huntsville, Alabama, Stati Uniti, 35805-4046
- Reclutamento
- Rehabilitation & Neurological Services /ID# 248517
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Saraland, Alabama, Stati Uniti, 36571
- Reclutamento
- The Center for Clinical Trials - Saraland /ID# 271604
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72211
- Reclutamento
- Preferred Research Partners /ID# 249729
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Little Rock, Arkansas, Stati Uniti, 72211
- Completato
- Preferred Research Partners /ID# 270406
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California
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Anaheim, California, Stati Uniti, 92805
- Reclutamento
- Advanced Research Center /ID# 251381
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Long Beach, California, Stati Uniti, 90807
- Reclutamento
- Alliance for Research Alliance for Wellness /ID# 248521
-
Oceanside, California, Stati Uniti, 92056
- Completato
- Excell Research, Inc /ID# 247532
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San Jose, California, Stati Uniti, 95124-4108
- Reclutamento
- Lumos Clinical Research Center /ID# 249731
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Walnut Creek, California, Stati Uniti, 94596
- Reclutamento
- Sunwise Clinical Research /ID# 248529
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Colorado
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Fort Collins, Colorado, Stati Uniti, 80528
- Completato
- Advanced Neurosciences Research, LLC /ID# 247592
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Florida
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Gulf Breeze, Florida, Stati Uniti, 32561-4495
- Completato
- Northwest Florida Clinical Research Group, LLC /ID# 251382
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Homestead, Florida, Stati Uniti, 33030-4613
- Completato
- Advanced Research Institute of Miami /ID# 248539
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Miami, Florida, Stati Uniti, 33155
- Reclutamento
- My Preferred Research LLC /ID# 249720
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Spring Hill, Florida, Stati Uniti, 34609-5692
- Completato
- FWD Clinical Research - Spring Hill /ID# 248525
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Georgia
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Brunswick, Georgia, Stati Uniti, 31520-1601
- Reclutamento
- Coastal Georgia Child Neurology /ID# 249733
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Contatto:
- Site Coordinator
- Numero di telefono: 770-376-7912
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Indiana
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Newburgh, Indiana, Stati Uniti, 47630
- Reclutamento
- Deaconess Clinic - Gateway Health Center /ID# 247589
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Contatto:
- Site Coordinator
- Numero di telefono: 812-474-7184
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Kansas
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Overland Park, Kansas, Stati Uniti, 66210-2761
- Completato
- College Park Family Care Center Overland Park /ID# 249734
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Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48104-5131
- Reclutamento
- Michigan Headache & Neurological Institute (MHNI) /ID# 247468
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Contatto:
- Site Coordinator
- Numero di telefono: 734-677-6000
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Mississippi
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Ridgeland, Mississippi, Stati Uniti, 39157
- Reclutamento
- Proven Endpoints LLC /ID# 258066
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Contatto:
- Site Coordinator
- Numero di telefono: 601-790-1811
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Nebraska
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Papillion, Nebraska, Stati Uniti, 68046-4131
- Completato
- Cognitive Clinical Trials (CCT) - Papillion /ID# 248536
-
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New Jersey
-
Morristown, New Jersey, Stati Uniti, 07960
- Reclutamento
- Goryeb Childrens Hospital /ID# 249724
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New York
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Amherst, New York, Stati Uniti, 14226
- Reclutamento
- Dent Neurologic Institute - Amherst /ID# 248534
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Contatto:
- Site Coordinator
- Numero di telefono: 716-558-5670
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New York, New York, Stati Uniti, 10001
- Completato
- Modern Migraine MD /ID# 258074
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North Carolina
-
Greensboro, North Carolina, Stati Uniti, 27405
- Reclutamento
- Headache Wellness Center /ID# 251018
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Ohio
-
Cincinnati, Ohio, Stati Uniti, 45215-2123
- Reclutamento
- Patient Priority Clinical Sites, LLC /ID# 247535
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Contatto:
- Site Coordinator
- Numero di telefono: 513-791-7760
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Cincinnati, Ohio, Stati Uniti, 45229
- Reclutamento
- Cincinnati Childrens Hospital Medical Center /ID# 258070
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West Chester, Ohio, Stati Uniti, 45069
- Completato
- CincyScience /ID# 249726
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73112
- Completato
- Lynn Institute of Oklahoma City /ID# 247600
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104-4319
- Reclutamento
- Children's Hospital of Philadelphia - Main /ID# 258071
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Tennessee
-
Memphis, Tennessee, Stati Uniti, 38103
- Completato
- Le Bonheur Children's Hospital /ID# 261084
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Nashville, Tennessee, Stati Uniti, 37203
- Reclutamento
- Access Clinical Trials, Inc. /ID# 248532
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Texas
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Austin, Texas, Stati Uniti, 78723-3079
- Reclutamento
- UT Health Austin at Dell Children's Neurology Clinic /ID# 264082
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Austin, Texas, Stati Uniti, 78731
- Completato
- FutureSearch Trials of Neurology /ID# 247470
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El Paso, Texas, Stati Uniti, 79925-7945
- Completato
- 3A Research - East El Paso /ID# 248516
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Friendswood, Texas, Stati Uniti, 77546
- Reclutamento
- Earle Research /ID# 248501
-
Contatto:
- Site Coordinator
- Numero di telefono: 281-218-8080
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The Woodlands, Texas, Stati Uniti, 77381
- Completato
- Family Psychiatry of The Woodlands /ID# 249727
-
Waxahachie, Texas, Stati Uniti, 75165-1430
- Reclutamento
- ClinPoint Trials /ID# 248540
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Utah
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Bountiful, Utah, Stati Uniti, 84010-4968
- Reclutamento
- Pantheon Clinical Research /ID# 251601
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Clinton, Utah, Stati Uniti, 84015
- Reclutamento
- Alpine Research Organization - Clinton /ID# 276497
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Salt Lake City, Utah, Stati Uniti, 84124
- Reclutamento
- Highland Clinical Research /ID# 247590
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Virginia
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Franklin, Virginia, Stati Uniti, 23851
- Reclutamento
- Office of Maria Ona /ID# 249738
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Washington
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Everett, Washington, Stati Uniti, 98201
- Completato
- Core Clinical Research /ID# 249721
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-
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Mölnlycke, Svezia, 435 30
- Reclutamento
- Vastra Gotealandsregionen Regionhalsan /ID# 248277
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Stockholm County
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Stockholm, Stockholm County, Svezia, 118 83
- Reclutamento
- Sodersjukhuset /ID# 248279
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-
-
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Budapest, Ungheria, 1085
- Reclutamento
- Semmelweis Egyetem /ID# 248360
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Budapest, Ungheria, 1024
- Completato
- MIND Clinic /ID# 248687
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
|
|
Comparatore placebo: 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 |
|
Sperimentale: 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
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
|
|
Comparatore placebo: 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 |
|
Sperimentale: 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
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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 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
Lasso di tempo: 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
|
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 Headache Days of at Least Moderate Severity
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 Average of Monthly Migraine Days
Lasso di tempo: 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
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
- M21-201
- 2022-501100-94-00 (Altro identificatore: EU CT)
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 .