En undersøgelse til evaluering (BALSAM-1)
22. oktober 2026 opdateret af: Bristol-Myers Squibb
En fase 3, randomiseret, dobbeltblind, placebokontrolleret undersøgelse for at evaluere effektiviteten og sikkerheden af Karxt til behandling af maniske episoder i Bipolar-I Disorder (Balsam-1)
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in subjects with bipolar disorder experiencing an acute episode of mania or mania with mixed features.
The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
274
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: First line of the email MUST contain NCT # and Site #.
Undersøgelse Kontakt Backup
- Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonnummer: 855-907-3286
- E-mail: Clinical.Trials@bms.com
Studiesteder
-
-
-
Córdoba, Argentina, 5000
- Rekruttering
- Sanatorio Morra S.A.
-
Kontakt:
- Carlos Morra, Site 0115
- Telefonnummer: 5493516858696
-
Mendoza, Argentina, 5502
- Ikke rekrutterer endnu
- Local Institution - 0109
-
Kontakt:
- Site 0109
-
Santiago del Estero, Argentina, G4200DND
- Ikke rekrutterer endnu
- Local Institution - 0140
-
Kontakt:
- Site 0140
-
-
Buenos Aires F.D.
-
ABB, Buenos Aires F.D., Argentina, C1199ABB
- Rekruttering
- Hospital Italiano de Buenos Aires
-
Kontakt:
- José Faccioli, Site 0110
- Telefonnummer: +5491157934078
-
-
Mendoza Province
-
Las Heras, Mendoza Province, Argentina, 5539
- Rekruttering
- Clinica del Prado
-
Kontakt:
- Eugenio Velasco, Site 0108
- Telefonnummer: 54-261-9-155861633
-
-
-
-
New South Wales
-
St Leonards, New South Wales, Australien, 2065
- Rekruttering
- Ramsay Clinic Northside
-
Kontakt:
- Philip Mitchell, Site 0117
- Telefonnummer: +61 2 9433 3555
-
-
Queensland
-
Brisbane, Queensland, Australien, 4005
- Rekruttering
- Ramsay Clinic New Farm
-
Kontakt:
- James Scott, Site 0106
- Telefonnummer: +61 7 3069 7398
-
-
-
-
-
Burgas, Bulgarien, 8001
- Rekruttering
- Center for Mental Health Prof. Dr. Ivan Temkov
-
Kontakt:
- Veselin Palazov, Site 0113
- Telefonnummer: 359888451225
-
Haskovo, Bulgarien, 6300
- Ikke rekrutterer endnu
- Local Institution - 0139
-
Kontakt:
- Site 0139
-
Novi Iskar, Bulgarien, 1282
- Rekruttering
- State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
-
Kontakt:
- Tsveteslava Galabova, Site 0119
- Telefonnummer: 359892444643
-
Pleven, Bulgarien, 5800
- Rekruttering
- "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
-
Kontakt:
- Maya Stoimenova - Popova, Site 0112
- Telefonnummer: +359888227165
-
Sliven, Bulgarien, 8800
- Rekruttering
- MHAT "Dr. Ival Seliminski"
-
Kontakt:
- Rozalina Petrova, Site 0120
- Telefonnummer: 00359887801545
-
Vratsa, Bulgarien, 3000
- Rekruttering
- Mental Health Center - Vratsa
-
Kontakt:
- Nadya Ivanova, Site 0121
- Telefonnummer: +359887422440
-
-
Stara Zagora
-
Kazanlak, Stara Zagora, Bulgarien, 6100
- Ikke rekrutterer endnu
- Local Institution - 0138
-
Kontakt:
- Site 0138
-
-
-
-
Arkansas
-
Bentonville, Arkansas, Forenede Stater, 72712
- Aktiv, ikke rekrutterende
- Local Institution - 0058
-
Little Rock, Arkansas, Forenede Stater, 72211
- Rekruttering
- Woodland International Research Group
-
Kontakt:
- George Konis, Site 0011
- Telefonnummer: 501-221-8681
-
-
California
-
Anaheim, California, Forenede Stater, 92805
- Rekruttering
- Advanced Research Center Inc.
-
Kontakt:
- Steven Macina, Site 0005
- Telefonnummer: 714-999-6688
-
Bellflower, California, Forenede Stater, 90706
- Rekruttering
- CITrials
-
Kontakt:
- Gerald Maguire, Site 0008
- Telefonnummer: 562-249-6956
-
Cerritos, California, Forenede Stater, 90703
- Ikke rekrutterer endnu
- Local Institution - 0014
-
Kontakt:
- Site 0014
-
Long Beach, California, Forenede Stater, 90806
- Rekruttering
- Collaborative Neuroscience Research, LLC
-
Kontakt:
- David Walling, Site 0059
- Telefonnummer: 714-799-7799
-
Los Angeles, California, Forenede Stater, 90015
- Rekruttering
- NRC Research Institute
-
Kontakt:
- Tony Ortiz, Site 0053
- Telefonnummer: 714-289-1100
-
Montclair, California, Forenede Stater, 91763
- Rekruttering
- Catalina Research Institute, LLC
-
Kontakt:
- Stephen Volk, Site 0072
- Telefonnummer: 909-590-8409
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06519
- Rekruttering
- Connecticut Mental Health Center
-
Kontakt:
- Deepak D'Souza, Site 0124
- Telefonnummer: 20393257112594
-
-
Florida
-
Hollywood, Florida, Forenede Stater, 33024
- Rekruttering
- Research Centers of America ( Hollywood )
-
Kontakt:
- Edwin Gomez, Site 0043
- Telefonnummer: 954-604-3900
-
Homestead, Florida, Forenede Stater, 33033
- Rekruttering
- Advanced Research Institute of Miami
-
Kontakt:
- Moraima Trujillo, Site 0020
- Telefonnummer: 305-246-0001
-
Miami, Florida, Forenede Stater, 33166
- Rekruttering
- South Florida Research Phase I-IV
-
Kontakt:
- Silvia Silva Duluc, Site 0069
- Telefonnummer: 305-669-6166
-
Miami Lakes, Florida, Forenede Stater, 33016
- Rekruttering
- Innovative Clinical Research, Inc.
-
Kontakt:
- Rishi Kakar, Site 0054
- Telefonnummer: 786-512-4106
-
Miami Lakes, Florida, Forenede Stater, 33016
- Ikke rekrutterer endnu
- Local Institution - 0015
-
Kontakt:
- Site 0015
-
West Palm Beach, Florida, Forenede Stater, 33407
- Rekruttering
- Health Synergy Clinical Research
-
Kontakt:
- Mohammad Nisar, Site 0023
- Telefonnummer: 786-831-7303
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30328
- Rekruttering
- Synexus Clinical Research US, Inc.
-
Kontakt:
- Bethany Davis, Site 0009
- Telefonnummer: 404-255-6005
-
Savannah, Georgia, Forenede Stater, 31405
- Rekruttering
- CenExel iResearch, LLC
-
Kontakt:
- Michael Mobley, Site 0057
- Telefonnummer: 912-744-0800
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60641
- Rekruttering
- Pillar Clinical Research -Chicago
-
Kontakt:
- Roueen Rafeyan, Site 0047
- Telefonnummer: 312-865-6336
-
-
New York
-
Staten Island, New York, Forenede Stater, 10314
- Rekruttering
- Richmond Behavioral Associates
-
Kontakt:
- Peter Weiden, Site 0030
- Telefonnummer: 917-701-7484
-
-
Ohio
-
North Canton, Ohio, Forenede Stater, 44720
- Rekruttering
- Neuro-Behavioral Clinical Research
-
Kontakt:
- Shishuka Malhotra, Site 0013
- Telefonnummer: 330-493-1118
-
-
Texas
-
Austin, Texas, Forenede Stater, 78754
- Rekruttering
- Community Clinical Research
-
Kontakt:
- David Brown, Site 0141
- Telefonnummer: 512-323-2622
-
Irving, Texas, Forenede Stater, 75062
- Trukket tilbage
- Local Institution - 0029
-
Richardson, Texas, Forenede Stater, 75080
- Rekruttering
- Pillar Clinical Research - Richardson
-
Kontakt:
- Scott Bartley, Site 0044
- Telefonnummer: 214-396-4844
-
-
-
-
-
Fukuoka, Japan, 819-0037
- Rekruttering
- Kuramitsu Hospital
-
Kontakt:
- Noriko Tamaru, Site 0083
- Telefonnummer: +81-92-811-1821
-
Miyazaki, Japan, 880-8510
- Rekruttering
- Miyazaki Prefectural Miyazaki Hospital
-
Kontakt:
- Jiro Kawano, Site 0077
- Telefonnummer: 81985244181
-
Osaka, Japan, 590-0018
- Trukket tilbage
- Local Institution - 0084
-
Osaka, Japan, 545-8586
- Rekruttering
- Osaka Metropolitan University Hospital
-
Kontakt:
- Yasuhiko Deguchi, Site 0086
- Telefonnummer: +81-6-6645-3821
-
Tokyo, Japan, 157-8577
- Rekruttering
- Showa Medical University Karasuyama Hospital
-
Kontakt:
- Kenji Sanada, Site 0104
- Telefonnummer: +81-3-3300-5231
-
Wakayama, Japan, 641-8510
- Rekruttering
- Wakayama Medical University Hospital
-
Kontakt:
- Sohei Kimoto, Site 0076
- Telefonnummer: 073-441-0659
-
Yamagata, Japan, 990-0045
- Rekruttering
- Yamagata Sakuracho Hospital
-
Kontakt:
- Nobuhiro Yokokawa, Site 0088
- Telefonnummer: +81236312315
-
-
Aichi-ken
-
Kōnan, Aichi-ken, Japan, 4838248
- Afsluttet
- Local Institution - 0082
-
Toyoake, Aichi-ken, Japan, 470-1168
- Rekruttering
- Okehazama Hospital
-
Kontakt:
- kiyoshi Fujita, Site 0079
- Telefonnummer: 0562971361
-
-
Chiba
-
Ichikawa, Chiba, Japan, 272-8516
- Rekruttering
- National Kohnodai Medical Center.
-
Kontakt:
- Toshihiko Ito, Site 0078
- Telefonnummer: +81-47-372-3501
-
-
Fukuoka
-
Kitakyushu, Fukuoka, Japan, 803-0831
- Trukket tilbage
- Local Institution - 0100
-
-
Hokkaido
-
Obihiro, Hokkaido, Japan, 080-0024
- Rekruttering
- Obihiro Kosei Hospital
-
Kontakt:
- Kengo Furuse, Site 0090
- Telefonnummer: 81155650102
-
Sapporo, Hokkaido, Japan, 002-8029
- Rekruttering
- Goryokai Medical Corporation - Goryokai Hospital
-
Kontakt:
- Kimihiro Nakajima, Site 0080
- Telefonnummer: +81-11-771-5660
-
-
Osaka
-
Moriguchi, Osaka, Japan, 570-8507
- Rekruttering
- Kansai Medical University Medical Center
-
Kontakt:
- Masaki Kato, Site 0089
- Telefonnummer: +81-6-6992-1001
-
-
Saga-ken
-
Karatsu-shi, Saga-ken, Japan, 847-0031
- Rekruttering
- Rainbow and Sea Hospital
-
Kontakt:
- Taro Shindo, Site 0087
- Telefonnummer: 0955770711
-
-
Saitama
-
Iruma, Saitama, Japan, 350-0495
- Trukket tilbage
- Local Institution - 0081
-
Kumagaya, Saitama, Japan, 360-0114
- Rekruttering
- Saitama Konan Hospital
-
Kontakt:
- Narifumi Yokoyama, Site 0092
- Telefonnummer: 048-536-1366
-
-
Tokyo
-
Kodaira, Tokyo, Japan, 187-8551
- Rekruttering
- National Center of Neurology and Psychiatry
-
Kontakt:
- Takamasa Noda, Site 0105
- Telefonnummer: +81-42-341-2711
-
tabashi City, Tokyo, Japan, 175-0091
- Rekruttering
- Narimasu Kosei Hospital
-
Kontakt:
- Yuya Tenjin, Site 0085
- Telefonnummer: 0339391191
-
-
-
-
-
Auckland, New Zealand, 0622
- Rekruttering
- North Shore Hospital
-
Kontakt:
- Sylvester Miles, Site 0055
- Telefonnummer: +6421963555
-
-
-
-
-
Tuszyn, Polen, 95-080
- Rekruttering
- Clinica Inventiva
-
Kontakt:
- Jaroslaw Strzelec, Site 0096
- Telefonnummer: 602305132
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polen, 61-485
- Rekruttering
- Centrum Medyczne HCP
-
Kontakt:
- Sylwia Szymkowiak, Site 0095
- Telefonnummer: +48604116632
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polen, 02-957
- Rekruttering
- Instytut Psychiatrii i Neurologii
-
Kontakt:
- Adam Wichniak, Site 0107
- Telefonnummer: +48600-107-410
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, Polen, 15-272
- Rekruttering
- Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku
-
Kontakt:
- Napoleon Waszkiewicz, Site 0094
- Telefonnummer: +48608888796
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Polen, 80-214
- Ikke rekrutterer endnu
- Local Institution - 0111
-
Kontakt:
- Site 0111
-
-
Silesian Voivodeship
-
Rybnik, Silesian Voivodeship, Polen, 44-200
- Rekruttering
- M2M Med
-
Kontakt:
- Wojciech Eysymontt, Site 0103
- Telefonnummer: +48609673001
-
Sosnowiec, Silesian Voivodeship, Polen, 41-200
- Ikke rekrutterer endnu
- Local Institution - 0102
-
Kontakt:
- Site 0102
-
-
-
-
-
Kyiv, Ukraine, 04080
- Rekruttering
- CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)
-
Kontakt:
- Yuliya Blazhevych, Site 0129
- Telefonnummer: +380503847048
-
Poltava, Ukraine, 36013
- Rekruttering
- Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"
-
Kontakt:
- Andriy Skrypnikov, Site 0132
- Telefonnummer: +380502523300
-
Smila, Ukraine, 20708
- Rekruttering
- Communal non-commercial enterprise "Cherkasy regional psychiatric hospital of Cherkasy regional council"
-
Kontakt:
- Iryna Kosenkova, Site 0131
- Telefonnummer: 380473321979
-
Ternopil, Ukraine, 46027
- Ikke rekrutterer endnu
- Local Institution - 0137
-
Kontakt:
- Site 0137
-
-
Dnipropetrovsk Oblast
-
Dnipro, Dnipropetrovsk Oblast, Ukraine, 49115
- Rekruttering
- MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC
-
Kontakt:
- Svitlana Moroz, Site 0130
- Telefonnummer: +380675658914
-
-
Khmelnytskyi Oblast
-
Skarzhyntsi, Khmelnytskyi Oblast, Ukraine, 32120
- Rekruttering
- Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council
-
Kontakt:
- Viktoriia Kachynska, Site 0133
- Telefonnummer: 380672624158
-
-
Kirovohrad Oblast
-
Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25491
- Rekruttering
- Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council
-
Kontakt:
- Yevhen Denysov, Site 0126
- Telefonnummer: +380505641035
-
-
-
-
-
Budapest, Ungarn, 1083
- Rekruttering
- Semmelweis Egyetem
-
Kontakt:
- János Réthelyi, Site 0118
- Telefonnummer: +3612100336
-
Budapest, Ungarn, 1135
- Rekruttering
- Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet
-
Kontakt:
- Csaba Almasi, Site 0114
- Telefonnummer: +36 30 604 9696
-
-
Győr-Moson-Sopron
-
Győr, Győr-Moson-Sopron, Ungarn, 9024
- Rekruttering
- Petz Aladar Egyetemi Oktato Korhaz
-
Kontakt:
- Gabor Feller, Site 0116
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria
- Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
- Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
- Participants must require hospitalization for the acute exacerbation or relapse of mania.
- Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
- Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
- Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.
Exclusion Criteria:
- Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
- Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
- Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test.
- Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Participants must not have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
- Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Specified dose on specified days |
|
Eksperimentel: KarXT
Flexible dosing |
Specified dose on specified days
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Young Mania Rating Scale (YMRS) score
Tidsramme: At week 3
|
The YMRS comprised of 11 items that assess the severity of manic symptoms. All items are given a severity rating, with 4 items graded from 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), and the remaining 7 items are graded from 0 to 4 points. The highest score obtainable on the YMRS is 60 and the higher the number the greater the number of symptoms and/or the greater their severity. |
At week 3
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Forekomst af respons baseret på CGI-BP-ændring fra baseline ≥ 1
Tidsramme: I uge 3
|
I uge 3
|
|
|
Forekomst af respons baseret på en ≥ 50% reduktion fra baseline i YMRS total score
Tidsramme: I uge 3
|
I uge 3
|
|
|
Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP)
Tidsramme: At week 3
|
The CGI-BP is designed to assess the severity, improvement, and efficacy of treatment in individuals with bipolar disorder. Only section I, illness severity, will be used, which includes three components: mania, depression, and overall bipolar illness. The ratings are on a 7-point scale (1 = normal, not ill; 2 = minimally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = very severely ill) |
At week 3
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
11. juni 2025
Primær færdiggørelse (Anslået)
1. november 2026
Studieafslutning (Anslået)
1. november 2026
Datoer for studieregistrering
Først indsendt
23. april 2025
Først indsendt, der opfyldte QC-kriterier
23. april 2025
Først opslået (Faktiske)
30. april 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CN012-0036
- 2024-520165-32 (Anden identifikator: EU CTR)
- U1111-1316-7438 (Anden identifikator: WHO)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
IPD-delingstidsramme
See Plan Description
IPD-delingsadgangskriterier
See Plan Description
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .