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NCT06966401RecruitingPhase 3

Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
850 (estimated)
First submitted
30 Apr 2025
Start date
16 Apr 2025
Primary completion date
31 May 2029
Lead sponsor
Neurocrine Biosciences
Diseases
Depression
NCT number
NCT06966401
EU CT number
2024-519423-24-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 850
  • From 16 Apr 2025 to the primary completion date, 31 May 2029
  • 137 sites in 23 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

  • A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.

Other

  • Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
    • Other protocol defined inclusion and exclusion criteria apply.

Who the study is looking for

  • Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
  • Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
  • Participant must have been taking oral antidepressants for at least 8 weeks prior to screening.
  • Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.

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

Full criteria on ClinicalTrials.gov

Sites (137)

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

SiteCityCountrySite status
Neurocrine Clinical Site
Coordinator of this site? Confirm its status
CarltonAustraliaRecruiting
Neurocrine Clinical Site
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MelbourneAustraliaRecruiting
Anima
Coordinator of this site? Confirm its status
AlkenBelgiumRecruiting
Az Sint-Lucas
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BruggeBelgiumRecruiting
Meclinas
Coordinator of this site? Confirm its status
MechelenBelgiumRecruiting
Medical Center Lifemed EOOD
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KirdzhaliBulgariaRecruiting
Medical Center Mentalcare Ltd.
Coordinator of this site? Confirm its status
PlovdivBulgariaRecruiting
Center For Mental Health Ruse EOOD
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RuseBulgariaRecruiting
Medical Center Intermedica Ltd.
Coordinator of this site? Confirm its status
SofiaBulgariaRecruiting
Medical Center Hera EOOD
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SofiyaBulgariaRecruiting
Medical Center Saint Naum EOOD
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SofiyaBulgariaRecruiting
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
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SofiyaBulgariaRecruiting
Diagnostics-Consultancy Center Mladost M Varna OOD
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VarnaBulgariaRecruiting
Neurocrine Clinical Site
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North VancouverCanadaRecruiting
Neurocrine Clinical Site
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TorontoCanadaRecruiting
Narodni Ustav Dusevniho Zdravi
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KlecanyCzechiaRecruiting
Psychiatricka ambulance MUDr Marta Ondrusova
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KurimCzechiaRecruiting
A-Shine s.r.o.
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Plzen 3CzechiaRecruiting
INEP medical s.r.o.
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PragueCzechiaRecruiting
Neuropsychiatrie Petrska s.r.o.
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PragueCzechiaRecruiting
Medical Services Prague S R O
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PragueCzechiaRecruiting
Praglandia s.r.o.
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PragueCzechiaRecruiting
Clintrial s.r.o.
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Prague 10CzechiaRecruiting
Marienthali Kliinik OÜ
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TallinnEstoniaRecruiting
Arstikeskus Confido AS
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TallinnEstoniaRecruiting
Tartu University Hospital
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Tartu LinnEstoniaRecruiting
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hestia Palau S.L.
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BarcelonaSpainRecruiting
Savon Psykiatripalvelu Oy
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KuopioFinlandRecruiting
Oulu Mentalcare Oy
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OuluFinlandRecruiting
Mehilaeinen Oy
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TampereFinlandRecruiting
Neurocrine Clinical Site
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LondonUnited KingdomRecruiting
Neurocrine Clinical Site
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ManchesterUnited KingdomWithdrawn
Neurocrine Clinical Site
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SheffieldUnited KingdomRecruiting
Neurocrine Clinical Site
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SouthamptonUnited KingdomWithdrawn
KBC Zagreb
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Grad ZagrebCroatiaRecruiting
Clinic for psychiatry Sveti Ivan
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Grad ZagrebCroatiaRecruiting
Klinika za psihijatriju Vrapce
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Grad ZagrebCroatiaRecruiting
Poliklinika Solmed d.o.o.
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Grad ZagrebCroatiaRecruiting
Semmelweis University
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BudapestHungaryRecruiting
Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet
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BudapestHungaryRecruiting
Obudai Egeszseguegyi Centrum Kft.
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Budapest IIIHungaryRecruiting
Gyoengyosi Bugat Pal Koerhaz
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GyongyosHungaryRecruiting
Dr. Mathe Es Tarsa Bt.
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KalocsaHungaryRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyRecruiting
Neurocrine Clinical Site
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Gyeonggi-doSouth KoreaRecruiting
Neurocrine Clinical Site
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SeoulSouth KoreaRecruiting
Saules seimos medicinos centras UAB
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KaunasLithuaniaRecruiting
Romuvos klinika UAB
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KaunasLithuaniaRecruiting
Respublikine Klaipedos ligonine VšĮ
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KlaipedaLithuaniaRecruiting
Vilnius City Mental Health Center
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VilniusLithuaniaRecruiting
Lietuvos sveikatos mokslu universiteto Kauno ligonine
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Ziegzdriu K.LithuaniaRecruiting
Slimnica Gintermuiza VSIA
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JelgavaLatviaRecruiting
L. Keruze practice in Psychiatry
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LiepajaLatviaRecruiting
Siguldas Slimnica
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Siguldas PagastsLatviaRecruiting
Brain Research Center Amsterdam B.V.
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AmsterdamNetherlandsCompleted
Universitair Medisch Centrum Groningen
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GroningenNetherlandsCompleted
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsCompleted
Brain Research Center Den Bosch B.V.
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's-HertogenboschNetherlandsCompleted
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
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BelchatowPolandRecruiting
MłynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Łazarczyk
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BiałystokPolandRecruiting
Prywatne Gabinety Lekarskie „Promedicus” Anna Agnieszka Tomczak
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BiałystokPolandRecruiting
Podlaskie Centrum Psychogeriatrii
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Bia?ystokPolandRecruiting
Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
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BydgoszczPolandRecruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandRecruiting
Centrum Zdrowia Alcea
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GdanskPolandRecruiting
Przychodnie Grudziadz sp. z o.o.
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GrudziądzPolandRecruiting
Clinic BBP Bożena Pawełczyk
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KatowicePolandRecruiting
Care Clinic Sp. Z O.O.
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KatowicePolandRecruiting
Osrodek Badan Klinicznych Clinsante s.c. Ewa Galczak-Nowak Malgorzata Trzaska
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TorunPolandRecruiting
Gyncentrum Sp. z o. o.
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WarsawPolandRecruiting
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
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BucharestRomaniaRecruiting
Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian
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BucharestRomaniaRecruiting
Institutul Privat de Cercetari Melchisedec, pentru Boli Autoimune, Ereditare si Rare - IPCM
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CraiovaRomaniaRecruiting
Spitalul Clinic Judetean De Urgenta Bihor
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OradeaRomaniaRecruiting
Neurocrine Clinical Site
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BelgradeSerbiaRecruiting
Neurocrine Clinical Site
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KragujevacSerbiaRecruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GothenburgSwedenRecruiting
ProbarE i Lund AB
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LundSwedenRecruiting
ProbarE i Stockholm AB
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StockholmSwedenRecruiting
Dana Ignjatovićová, spol. s r.o
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Banská BystricaSlovakiaRecruiting
Centrum Zdravia R.B.K. s.r.o.
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BardejovSlovakiaRecruiting
Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
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BojniceSlovakiaRecruiting
Epamed s.r.o.
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Kosice - ZapadSlovakiaRecruiting
PsychoLine s.r.o.
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Rimavska SobotaSlovakiaRecruiting
Mentum s.r.o.
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Stare MestoSlovakiaRecruiting
Crystal Comfort S.R.O.
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Vranov nad TopľouSlovakiaRecruiting
Neurocrine Clinical Site
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KeelungTaiwanRecruiting
Neurocrine Clinical Site
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TaipeiTaiwanWithdrawn
Neurocrine Clinical Site
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AtlantaUnited StatesRecruiting
Neurocrine Clinical Site
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Avon LakeUnited StatesRecruiting
Neurocrine Clinical Site
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BellaireUnited StatesWithdrawn
Neurocrine Clinical Site
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BostonUnited StatesRecruiting
Neurocrine Clinical Site
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BryantUnited StatesRecruiting
Neurocrine Clinical Site
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CedarhurstUnited StatesRecruiting
Neurocrine Clinical Site
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ChinoUnited StatesRecruiting
Neurocrine Clinical Site
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CromwellUnited StatesRecruiting
Neurocrine Clinical Site
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DallasUnited StatesRecruiting
Neurocrine Clinical Site
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DeSotoUnited StatesRecruiting
Neurocrine Clinical Site
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DraperUnited StatesRecruiting
Neurocrine Clinical Site
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EdmondUnited StatesRecruiting
Neurocrine Clinical Site
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FarmingtonUnited StatesRecruiting
Neurocrine Clinical Site
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GaithersburgUnited StatesRecruiting
Neurocrine Clinical Site
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GlendaleUnited StatesRecruiting
Neurocrine Clinical Site
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HollywoodUnited StatesRecruiting
Neurocrine Clinical Site
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HoustonUnited StatesRecruiting
Neurocrine Clinical Site
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HuntsvilleUnited StatesRecruiting
Neurocrine Clinical Site
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IrvineUnited StatesRecruiting
Neurocrine Clinical Site
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Little RockUnited StatesRecruiting
Neurocrine Clinical Site
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Los AngelesUnited StatesRecruiting
Neurocrine Clinical Site
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MaitlandUnited StatesRecruiting
Neurocrine Clinical Site
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MiamiUnited StatesRecruiting
Neurocrine Clinical Site
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Miami GardensUnited StatesRecruiting
Neurocrine Clinical Site
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Mount KiscoUnited StatesRecruiting
Neurocrine Clinical Site
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New YorkUnited StatesRecruiting
Neurocrine Clinical Site
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OceansideUnited StatesRecruiting
Neurocrine Clinical Site
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O'FallonUnited StatesRecruiting
Neurocrine Clinical Site
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Oklahoma CityUnited StatesWithdrawn
Neurocrine Clinical Site
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OrangeUnited StatesRecruiting
Neurocrine Clinical Site
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OrlandoUnited StatesWithdrawn
Neurocrine Clinical Site
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Palm BayUnited StatesRecruiting
Neurocrine Clinical Site
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PhiladelphiaUnited StatesRecruiting
Neurocrine Clinical Site
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Pico RiveraUnited StatesRecruiting
Neurocrine Clinical Site
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RichmondUnited StatesWithdrawn
Neurocrine Clinical Site
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Saint CharlesUnited StatesRecruiting
Neurocrine Clinical Site
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San DiegoUnited StatesRecruiting
Neurocrine Clinical Site
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San FranciscoUnited StatesActive, not recruiting
Neurocrine Clinical Site
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San JoseUnited StatesRecruiting
Neurocrine Clinical Site
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StaffordUnited StatesRecruiting
Neurocrine Clinical Site
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TampaUnited StatesRecruiting
Neurocrine Clinical Site
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The BronxUnited StatesRecruiting
Neurocrine Clinical Site
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The WoodlandsUnited StatesRecruiting
Neurocrine Clinical Site
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UplandUnited StatesTerminated
Neurocrine Clinical Site
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WatertownUnited StatesRecruiting

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