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NCT07775300RecruitingPhase 3

A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD- 2)

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into four periods as follows: a screening period that will last approximately 1 month, a treatment period and a post- treatment period that combined will last a minimum of 12 months, and the safety follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
14 Aug 2026
Start date
14 Aug 2026
Primary completion date
31 Dec 2028
Lead sponsor
Eli Lilly and Company
Diseases
Depression
NCT number
NCT07775300
EU CT number
2025-522310-24-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1000
  • From 14 Aug 2026 to the primary completion date, 31 Dec 2028
  • 170 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

Other illness

  • Have a lifetime history or current diagnosis of the following:
    • schizophrenia spectrum or other psychotic disorder
    • bipolar disorder
    • borderline personality disorder, or
    • any eating disorder
  • Have type 1 diabetes mellitus, or a history of:
    • ketoacidosis, or
    • hyperosmolar state or coma.
  • Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening

Other

  • Are actively suicidal or deemed a significant risk for suicide

Who the study is looking for

  • Meet the diagnostic criteria for major depressive disorder
  • Are on stable standard of care medication for major depressive disorder
  • Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as
    • self-inject study intervention
    • store and use the provided blinded study intervention, as directed
    • maintain electronic and paper study diaries, as applicable, and
    • complete the required questionnaires

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (170)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ramsay Clinic New Farm
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BrisbaneAustraliaNot yet recruiting
Paratus Clinical Research Canberra
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BruceAustraliaNot yet recruiting
NeuroCentrix
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CarltonAustraliaNot yet recruiting
Lyell McEwin Hospital
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Elizabeth ValeAustraliaNot yet recruiting
Barwon Health
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GeelongAustraliaNot yet recruiting
Ramsay Clinic Albert Road
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MelbourneAustraliaNot yet recruiting
Multidisciplinary Alfred Psychiatry Research Centre
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MelbourneAustraliaNot yet recruiting
Toowoomba Hospital
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ToowoombaAustraliaNot yet recruiting
Westmead Hospital
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WestmeadAustraliaNot yet recruiting
Instituto de Pesquisa Clínica de Campinas
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CampinasBrazilNot yet recruiting
Cline Research Center
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CuritibaBrazilNot yet recruiting
Clinica Neurologica
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JoinvilleBrazilNot yet recruiting
Instituto Mederi de Pesquisa e Saude
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Passo FundoBrazilNot yet recruiting
Hospital das Clínicas - UFPE
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RecifeBrazilNot yet recruiting
Centro Multidisciplinar de Estudos Clinicos
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São Bernardo do CampoBrazilNot yet recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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São José do Rio PretoBrazilNot yet recruiting
PSEG Centro de Pesquisa Clinica
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São PauloBrazilRecruiting
CEPIC - Centro Paulista de Investigação Clínica
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São PauloBrazilNot yet recruiting
CEDOES
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VitóriaBrazilNot yet recruiting
Integral Pesquisa e Ensino
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VotuporangaBrazilNot yet recruiting
CaRe Clinic
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CalgaryCanadaNot yet recruiting
Kelowna Health and Memory Centre
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KelownaCanadaNot yet recruiting
Providence Care
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KingstonCanadaNot yet recruiting
Alpha Recherche Clinique - Lévis
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LévisCanadaNot yet recruiting
AMNDX
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MarkhamCanadaNot yet recruiting
Malton Medical Group
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MississaugaCanadaNot yet recruiting
Alpha Recherche Clinique
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QuébecCanadaNot yet recruiting
Richmond Clinical Trials
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RichmondCanadaNot yet recruiting
Research, Innovation, Science and Excellence (RISE) Institute
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TorontoCanadaNot yet recruiting
Beijing Anding Hospital - Affiliated Capital University of Medical Science
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BeijingChinaRecruiting
Chaohu Hospital of Anhui Medical University
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ChaohuChinaRecruiting
Shandong Mental Health Center
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JinanChinaRecruiting
Linfen Central Hospital
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LinfenChinaRecruiting
Shanghai Tongji Hospital
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ShanghaiChinaRecruiting
Suzhou Guangji Hospital
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SuzhouChinaRecruiting
Tianjin Anding Hospital
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TianjinChinaNot yet recruiting
The Affiliated Kangning Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
Wuhu Hospital of Beijing Anding hospital
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WuhuChinaRecruiting
Zhenjiang mental health center
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ZhenjiangChinaRecruiting
FutureMeds GmbH
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BerlinGermanyRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Pharmakologisches Studienzentrum Chemnitz GmbH
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ChemnitzGermanyRecruiting
Klinische Forschung Hamburg GmbH
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HamburgGermanyRecruiting
Universitaet Leipzig
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LeipzigGermanyRecruiting
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH
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SchwerinGermanyRecruiting
Hestia Palau S.L.
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
EAP Osona Sud - Alt Congost S.L.P
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CentellesSpainRecruiting
Hospital Universitario Infanta Leonor
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MadridSpainRecruiting
Complejo Asistencial Universitario de Salamanca
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SalamancaSpainRecruiting
Parc Sanitari Sant Joan de Déu
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Sant Boi de LlobregatSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
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SevillaSpainRecruiting
Hospital Provincial de Zamora
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ZamoraSpainRecruiting
Servicio de Salud Mental del Área IV CSM La Corredoría Oviedo
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-SpainRecruiting
Bodmin Community Hospital
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BodminUnited KingdomNot yet recruiting
Edinburgh Royal Infirmary
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EdinburghUnited KingdomNot yet recruiting
Devon Partnership Trust
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ExeterUnited KingdomNot yet recruiting
Queen Elizabeth University Hospital
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GlasgowUnited KingdomNot yet recruiting
Avrin - Liverpool
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LiverpoolUnited KingdomNot yet recruiting
Neuroclnx
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MotherwellUnited KingdomRecruiting
St Bartholomew's Medical Centre
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OxfordUnited KingdomRecruiting
Atlantic Medical
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PenzanceUnited KingdomNot yet recruiting
Ascend Clinical Research
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ReadingUnited KingdomRecruiting
Woodstock Bower Surgery
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RotherhamUnited KingdomRecruiting
Argolida General Hospital
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Argos-MykinesGreeceNot yet recruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceNot yet recruiting
Multidisciplinary Mental Health Hospital of Attiki
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Chaidari, AthensGreeceNot yet recruiting
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceNot yet recruiting
University General Hospital of Ioannina
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IoanninaGreeceNot yet recruiting
Sismanogleio General Hospital
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MaroussiGreeceNot yet recruiting
Pan-Arcadian General Hospital Of Tripoli Evangelistria
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TripolisGreeceNot yet recruiting
Kuramitsu Hospital
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FukuokaJapanNot yet recruiting
Medical corporation Shinseikai Kaku Mental Clinic
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FukuokaJapanNot yet recruiting
UNB Sumiyoshi Jinjamae Clinic
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Hakata-KuJapanNot yet recruiting
Hinotoyoda Cocoro Clinic
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HinoJapanNot yet recruiting
Rainbow and Sea Hospital
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KaratsuJapanNot yet recruiting
Kishiro Mental Clinic
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KawasakiJapanNot yet recruiting
Hiiragi Kokoro Clinic - Kokurain
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KitakyushuJapanNot yet recruiting
Juntendo Koshigaya Hospital
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KoshigayaJapanNot yet recruiting
Monzen-nakacho Mental Clinic
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Kōtō CityJapanNot yet recruiting
National Hospital Organization Shimofusa Psychiatric Medical Center
Coordinator of this site? Confirm its status
MIdori-ku, Chiba-shiJapanNot yet recruiting
Tokyo Nakano Mental Clinic
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Nakano CityJapanNot yet recruiting
Watanabe Clinic
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OsakaJapanNot yet recruiting
Yutaka Clinic
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SagamiharaJapanNot yet recruiting
Kitasato University Hospital
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SagamiharaJapanNot yet recruiting
Maynds Tower Mental Clinic
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Shibuya-kuJapanNot yet recruiting
Etoh Mentalclinic Meguro
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Shinagawa CityJapanNot yet recruiting
Tokumoto Komorebi Clinic
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SuitaJapanNot yet recruiting
Sangenjaya Nakamura Mental Clinic
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TokyoJapanNot yet recruiting
Ikebukuro Olive Mental Clinic
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Toshima CityJapanNot yet recruiting
Miki Mental Clinic
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YokohamaJapanNot yet recruiting
Yokohama Mental Clinic Totsuka
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YokohamaJapanNot yet recruiting
Korea University Ansan Hospital
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Ansan-siSouth KoreaNot yet recruiting
Chonnam National University Hospital
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GwangjuSouth KoreaNot yet recruiting
Jeju National University Hospital
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Jeju CitySouth KoreaNot yet recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
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SeoulSouth KoreaNot yet recruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaNot yet recruiting
Konkuk University Medical Center
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SeoulSouth KoreaNot yet recruiting
Seoul National University Hospital
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SeoulSouth KoreaNot yet recruiting
Asan Medical Center
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SeoulSouth KoreaNot yet recruiting
Samsung Medical Center
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SeoulSouth KoreaNot yet recruiting
Scientia Investigacion Clinica S.C.
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Chihuahua CityMexicoNot yet recruiting
Scientia Investigacion Clinica Tj
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Ciudad de TijuanaMexicoNot yet recruiting
Investigación Clínica Cuernavaca, S.C.
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CuernavacaMexicoNot yet recruiting
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
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CuliacánMexicoNot yet recruiting
Medical Care and Research Sa de Cv
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MéridaMexicoNot yet recruiting
Human Science Research Trials
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Mexico CityMexicoNot yet recruiting
RM Pharma Specialists
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Mexico CityMexicoNot yet recruiting
Ketamine Clinic México
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Mexico CityMexicoNot yet recruiting
FAICIC S. de R.L. de C.V.
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VeracruzMexicoNot yet recruiting
Núcleo de Investigación Médica Sur de Guadalajara
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ZapopanMexicoNot yet recruiting
Revit Sp. z o.o.
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BialystokPolandRecruiting
MentalMEDIC Grzegorz Giemza, Gliwickie Centrum Psychiatrii i Psychoterapii
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Bielsko-BiałaPolandRecruiting
In- Vivo Sp. z o. o.
Coordinator of this site? Confirm its status
BydgoszczPolandRecruiting
Diamond Clinic Sp. z o.o.
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CracowPolandRecruiting
Penta Hospitals Badania Kliniczne sp. z o.o.
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GdanskPolandRecruiting
NZOP Mentis
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LesznoPolandRecruiting
Santa SP. z o.o
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LodzPolandRecruiting
Nowy Szpital W Olkuszu Sp. z o.o.
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OlkuszPolandRecruiting
Praktyka Lekarska Małgorzata Wojtanowska-Bogacka
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PoznańPolandRecruiting
Ginemedica Sp. z o.o.
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WroclawPolandRecruiting
Clinhouse Sp. z o.o.
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ZabrzePolandRecruiting
Barbara Diaz Hernandez MD Research Inc
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San JuanPuerto RicoNot yet recruiting
INSPIRA Clinical Research
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San JuanPuerto RicoRecruiting
Instituto De Neurologia Dra. Ivonne Fraga
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San JuanPuerto RicoNot yet recruiting
Keelung Chang Gung Memorial Hospital
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KeelungTaiwanNot yet recruiting
Taichung Veterans General Hospital
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TaichungTaiwanNot yet recruiting
Chung Shan Medical University Hospital
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TaichungTaiwanNot yet recruiting
National Cheng Kung University Hospital
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TainanTaiwanNot yet recruiting
Taipei Veterans General Hospital
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TaipeiTaiwanNot yet recruiting
Cheng Hsin General Hospital
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TaipeiTaiwanNot yet recruiting
National Taiwan University Hospital
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TaipeiTaiwanNot yet recruiting
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanNot yet recruiting
JEM Research Institute
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AtlantisUnited StatesRecruiting
FutureSearch Trials of Neurology
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AustinUnited StatesNot yet recruiting
Pharmasite Research, Inc.
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BaltimoreUnited StatesRecruiting
Gadolin Research
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BeaumontUnited StatesRecruiting
Northwest Clinical Research Center
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BellevueUnited StatesRecruiting
University of Alabama at Birmingham School of Medicine
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BirminghamUnited StatesRecruiting
Adams Clinical Boston
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BostonUnited StatesRecruiting
Key Clinical Research
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BradentonUnited StatesRecruiting
Bradenton Research Center, Inc.
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BradentonUnited StatesRecruiting
Charter Research Chicago
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ChicagoUnited StatesRecruiting
CenExel iResearch, LLC
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DecaturUnited StatesNot yet recruiting
Adams Clinical Dallas
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DeSotoUnited StatesRecruiting
The University of Texas Rio Grande Valley
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HarlingenUnited StatesNot yet recruiting
NextPhase Research Florida - Hollywood
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HollywoodUnited StatesRecruiting
Irvine Clinical Research
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IrvineUnited StatesRecruiting
Olympus Clinical Research
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KatyUnited StatesRecruiting
Healthy Brain Clinic
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Long BeachUnited StatesNot yet recruiting
Diverse Clinical Research
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MiamiUnited StatesRecruiting
Quantix Research - Miami - Southwest 72nd Street
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MiamiUnited StatesRecruiting
Miami Jewish Health
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MiamiUnited StatesNot yet recruiting
CLA Research
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NaplesUnited StatesRecruiting
Oakland Clinical
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OaklandUnited StatesRecruiting
Be Well Clinical Studies - Omaha
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OmahaUnited StatesRecruiting
Adams Clinical Philadelphia
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PhiladelphiaUnited StatesRecruiting
Penn Medicine: University of Pennsylvania Health System
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PhiladelphiaUnited StatesRecruiting
NoesisPharma, LLC
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PhoenixUnited StatesRecruiting
Boeson Research - Provo
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ProvoUnited StatesRecruiting
AGILE Clinical Research Trials, LLC
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Sandy SpringsUnited StatesRecruiting
Adams Clinical Bronx
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The BronxUnited StatesRecruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
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TroyUnited StatesRecruiting
Concierge Clinical Trials
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Valley VillageUnited StatesRecruiting
Adams Clinical Watertown
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WatertownUnited StatesRecruiting
Suburban Research Associates
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West ChesterUnited StatesRecruiting
Health Synergy Clinical Research
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West Palm BeachUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.