En undersøgelse til vurdering af bivirkninger og ændringer i sygdomsaktivitet af orale atogepant-tabletter hos pædiatriske deltagere (6-17 år) med episodisk migræne
En fase 3, multicenter, 12-ugers, dobbeltblind, placebokontrolleret undersøgelse for at evaluere sikkerheden og effektiviteten af Atogepant til forebyggende behandling af episodisk migræne hos pædiatriske forsøgspersoner i alderen 6-17 år.
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.
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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Antwerpen
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Edegem, Antwerpen, Belgien, 2650
- Rekruttering
- Uza /Id# 247339
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West-Vlaanderen
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Bruges, West-Vlaanderen, Belgien, 8000
- Rekruttering
- Algemeen Ziekenhuis Sint-Jan Brugge /ID# 247201
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- Rekruttering
- Stollery Children's Hospital /ID# 249672
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Ontario
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London, Ontario, Canada, N6A 5W9
- Rekruttering
- London Health Sciences Center- University Hospital /ID# 252979
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- Afsluttet
- McGill University Health Centre - Glen Site /ID# 247271
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Capital Region
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Herlev, Capital Region, Danmark, 2730
- Rekruttering
- Herlev Hospital /ID# 247724
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Central Jutland
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Herning, Central Jutland, Danmark, 7400
- Rekruttering
- Regionshospitalet Godstrup /ID# 247902
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Kontakt:
- Site Coordinator
- Telefonnummer: +45 50935730
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North Denmark
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Aalborg, North Denmark, Danmark, 9000
- Afsluttet
- Aalborg Sygehus Nord /ID# 247428
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Aberdeen, Det Forenede Kongerige, AB15 6RE
- Rekruttering
- NHS Grampian /ID# 249067
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Stockport, Det Forenede Kongerige, SK2 7JE
- Rekruttering
- Stepping Hill Hospital-Stockport NHS foundation trust /ID# 261121
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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# 262933
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Kent
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Gillingham, Kent, Det Forenede Kongerige, ME7 5NY
- Rekruttering
- Medway NHS Foundation Trust /ID# 249065
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Alabama
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Huntsville, Alabama, Forenede Stater, 35805-4046
- Rekruttering
- Rehabilitation & Neurological Services /ID# 248517
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Saraland, Alabama, Forenede Stater, 36571
- Rekruttering
- The Center for Clinical Trials - Saraland /ID# 271604
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72211
- Rekruttering
- Preferred Research Partners /ID# 249729
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Little Rock, Arkansas, Forenede Stater, 72211
- Afsluttet
- Preferred Research Partners /ID# 270406
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California
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Anaheim, California, Forenede Stater, 92805
- Rekruttering
- Advanced Research Center /ID# 251381
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Long Beach, California, Forenede Stater, 90807
- Rekruttering
- Alliance for Research Alliance for Wellness /ID# 248521
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Oceanside, California, Forenede Stater, 92056
- Afsluttet
- Excell Research, Inc /ID# 247532
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San Jose, California, Forenede Stater, 95124-4108
- Rekruttering
- Lumos Clinical Research Center /ID# 249731
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Walnut Creek, California, Forenede Stater, 94596
- Rekruttering
- Sunwise Clinical Research /ID# 248529
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Colorado
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Fort Collins, Colorado, Forenede Stater, 80528
- Afsluttet
- Advanced Neurosciences Research, LLC /ID# 247592
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Florida
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Gulf Breeze, Florida, Forenede Stater, 32561-4495
- Afsluttet
- Northwest Florida Clinical Research Group, LLC /ID# 251382
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Homestead, Florida, Forenede Stater, 33030-4613
- Afsluttet
- Advanced Research Institute of Miami /ID# 248539
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Miami, Florida, Forenede Stater, 33155
- Rekruttering
- My Preferred Research LLC /ID# 249720
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Spring Hill, Florida, Forenede Stater, 34609-5692
- Afsluttet
- FWD Clinical Research - Spring Hill /ID# 248525
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Georgia
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Brunswick, Georgia, Forenede Stater, 31520-1601
- Rekruttering
- Coastal Georgia Child Neurology /ID# 249733
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Kontakt:
- Site Coordinator
- Telefonnummer: 770-376-7912
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Indiana
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Newburgh, Indiana, Forenede Stater, 47630
- Rekruttering
- Deaconess Clinic - Gateway Health Center /ID# 247589
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Kontakt:
- Site Coordinator
- Telefonnummer: 812-474-7184
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Kansas
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Overland Park, Kansas, Forenede Stater, 66210-2761
- Afsluttet
- College Park Family Care Center Overland Park /ID# 249734
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48104-5131
- Rekruttering
- Michigan Headache & Neurological Institute (MHNI) /ID# 247468
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Kontakt:
- Site Coordinator
- Telefonnummer: 734-677-6000
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Mississippi
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Ridgeland, Mississippi, Forenede Stater, 39157
- Rekruttering
- Proven Endpoints LLC /ID# 258066
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Kontakt:
- Site Coordinator
- Telefonnummer: 601-790-1811
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Nebraska
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Papillion, Nebraska, Forenede Stater, 68046-4131
- Afsluttet
- Cognitive Clinical Trials (CCT) - Papillion /ID# 248536
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New Jersey
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Morristown, New Jersey, Forenede Stater, 07960
- Rekruttering
- Goryeb Childrens Hospital /ID# 249724
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New York
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Amherst, New York, Forenede Stater, 14226
- Rekruttering
- Dent Neurologic Institute - Amherst /ID# 248534
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Kontakt:
- Site Coordinator
- Telefonnummer: 716-558-5670
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New York, New York, Forenede Stater, 10001
- Afsluttet
- Modern Migraine MD /ID# 258074
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North Carolina
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Greensboro, North Carolina, Forenede Stater, 27405
- Rekruttering
- Headache Wellness Center /ID# 251018
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45215-2123
- Rekruttering
- Patient Priority Clinical Sites, LLC /ID# 247535
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Kontakt:
- Site Coordinator
- Telefonnummer: 513-791-7760
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Cincinnati, Ohio, Forenede Stater, 45229
- Rekruttering
- Cincinnati Childrens Hospital Medical Center /ID# 258070
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West Chester, Ohio, Forenede Stater, 45069
- Afsluttet
- CincyScience /ID# 249726
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Afsluttet
- Lynn Institute of Oklahoma City /ID# 247600
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104-4319
- Rekruttering
- Children's Hospital of Philadelphia - Main /ID# 258071
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38103
- Afsluttet
- Le Bonheur Children's Hospital /ID# 261084
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Access Clinical Trials, Inc. /ID# 248532
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Texas
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Austin, Texas, Forenede Stater, 78723-3079
- Rekruttering
- UT Health Austin at Dell Children's Neurology Clinic /ID# 264082
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Austin, Texas, Forenede Stater, 78731
- Afsluttet
- FutureSearch Trials of Neurology /ID# 247470
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El Paso, Texas, Forenede Stater, 79925-7945
- Afsluttet
- 3A Research - East El Paso /ID# 248516
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Friendswood, Texas, Forenede Stater, 77546
- Rekruttering
- Earle Research /ID# 248501
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Kontakt:
- Site Coordinator
- Telefonnummer: 281-218-8080
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The Woodlands, Texas, Forenede Stater, 77381
- Afsluttet
- Family Psychiatry of The Woodlands /ID# 249727
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Waxahachie, Texas, Forenede Stater, 75165-1430
- Rekruttering
- ClinPoint Trials /ID# 248540
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Utah
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Bountiful, Utah, Forenede Stater, 84010-4968
- Rekruttering
- Pantheon Clinical Research /ID# 251601
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Clinton, Utah, Forenede Stater, 84015
- Rekruttering
- Alpine Research Organization - Clinton /ID# 276497
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Salt Lake City, Utah, Forenede Stater, 84124
- Rekruttering
- Highland Clinical Research /ID# 247590
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Virginia
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Franklin, Virginia, Forenede Stater, 23851
- Rekruttering
- Office of Maria Ona /ID# 249738
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Washington
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Everett, Washington, Forenede Stater, 98201
- Afsluttet
- Core Clinical Research /ID# 249721
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Toulouse, Frankrig, 31059
- Afsluttet
- CHU Toulouse - Hôpital des enfants /ID# 247553
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Somme
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Amiens, Somme, Frankrig, 80054
- Afsluttet
- CHU Amiens-Picardie Site Sud /ID# 248833
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Val-de-Marne
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Créteil, Val-de-Marne, Frankrig, 94000
- Afsluttet
- Centre Hosp Intercommunal de Creteil /ID# 248832
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Gelderland
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Nijmegen, Gelderland, Holland, 6532 SZ
- Rekruttering
- Canisius-Wilhelmina Ziekenhuis /ID# 253065
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South Holland
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The Hague, South Holland, Holland, 2545 AA
- Rekruttering
- HagaZiekenhuis /ID# 247318
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Zeeland
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Terneuzen, Zeeland, Holland, 4535 PA
- Rekruttering
- ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301
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Haifa, Israel, 3339419
- Rekruttering
- Bnai Zion Medical Center /ID# 247469
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Central District
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Beer Ya'akov, Central District, Israel, 70300
- Rekruttering
- Shamir Medical Center /ID# 256857
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Haifa District
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Hadera, Haifa District, Israel, 38100
- Afsluttet
- Hillel Yaffe Medical Center /ID# 246747
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Tel Aviv
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Ramat Gan, Tel Aviv, Israel, 5265601
- Rekruttering
- The Chaim Sheba Medical Center /ID# 246746
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Tel Aviv, Tel Aviv, Israel, 6423906
- Rekruttering
- Tel Aviv Sourasky Medical Center /ID# 247466
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Palermo, Italien, 90127
- Rekruttering
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 247638
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Milano
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Milan, Milano, Italien, 20133
- Rekruttering
- Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581
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Roma
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Rome, Roma, Italien, 00165
- Rekruttering
- Ospedale Pediatrico Bambino Gesu /ID# 247647
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Kyoto, Japan, 600-8811
- Rekruttering
- Tatsuoka Neurology Clinic /ID# 254455
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Hyōgo
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Kobe, Hyōgo, Japan, 658-0064
- Rekruttering
- Konan Medical Center /ID# 254457
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Nishinomiya, Hyōgo, Japan, 663-8204
- Rekruttering
- Yamaguchi Clinic /ID# 254753
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Kochi
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Kochi, Kochi, Japan, 780-8011
- Rekruttering
- Umenotsuji Clinic /ID# 254453
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Miyagi
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Sendai, Miyagi, Japan, 982-0014
- Rekruttering
- Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211
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Osaka
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Osaka, Osaka, Japan, 556-0015
- Rekruttering
- Tominaga Clinic - Osaka /ID# 254450
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 160-0023
- Rekruttering
- Tokyo Medical University Hospital /ID# 254459
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Wroclaw, Polen, 52-210
- Rekruttering
- 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, Polen, 60-848
- Rekruttering
- Clinical Research Center Medic-R /ID# 247383
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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# 248789
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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# 247384
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polen, 20-582
- Rekruttering
- Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247382
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 01-018
- Rekruttering
- Oha-Med Sp. Z O.O /ID# 248614
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Bayamón, Puerto Rico, 00960
- Afsluttet
- Clinical Research Investigator Group /ID# 261254
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Caguas, Puerto Rico, 00727
- Afsluttet
- Dr. Samuel Sanchez PSC /ID# 248495
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Dorado, Puerto Rico, 00646
- Rekruttering
- Puerto Rico Health Institute /ID# 249741
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Kontakt:
- Site Coordinator
- Telefonnummer: 787-797-1049
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San Juan, Puerto Rico, 00927
- Afsluttet
- PRCCI Clinical Research Center /ID# 262726
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San Juan, Puerto Rico, 00918-3501
- Afsluttet
- Caribbean Medical Research Center Headlands /ID# 251634
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Bucharest, Rumænien, 014146
- Afsluttet
- Delta Health Care S.R.L /ID# 248130
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Bucharest
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Bucharest, Bucharest, Rumænien, 022102
- Afsluttet
- Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 248431
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Cluj
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Cluj-Napoca, Cluj, Rumænien, 400012
- Afsluttet
- Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 248595
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Barcelona, Spanien, 08035
- Rekruttering
- Hospital Universitario Vall de Hebron /ID# 247967
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Madrid, Spanien, 28040
- Rekruttering
- Hospital Clinico San Carlos /ID# 249267
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Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre /ID# 275578
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Seville, Spanien, 41013
- Afsluttet
- Hospital Universitario Virgen del Rocio /ID# 248632
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Valencia, Spanien, 46026
- Afsluttet
- Hospital Universitario y Politecnico La Fe /ID# 247969
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Mölnlycke, Sverige, 435 30
- Rekruttering
- Vastra Gotealandsregionen Regionhalsan /ID# 248277
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Stockholm County
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Stockholm, Stockholm County, Sverige, 118 83
- Rekruttering
- Sodersjukhuset /ID# 248279
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Budapest, Ungarn, 1085
- Rekruttering
- Semmelweis Egyetem /ID# 248360
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Budapest, Ungarn, 1024
- Afsluttet
- MIND Clinic /ID# 248687
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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:
- 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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
|
|
Placebo komparator: 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 |
|
Eksperimentel: 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
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
|
|
Placebo komparator: 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 |
|
Eksperimentel: 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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
|
Change from Baseline in Mean Monthly Headache Days of at Least Moderate Severity
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
|
|
Change from Baseline in Mean Monthly Acute Medication Use Days
Tidsramme: 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
Tidsramme: 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
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
|
|
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
- M21-201
- 2022-501100-94-00 (Anden identifikator: EU CT)
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .