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NCT06323928CompletedPhase 2

A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-finding Trial of Lu AG09222 for the Prevention of Migraine in Participants With Unsuccessful Prior Preventive Treatments

Source: ClinicalTrials.gov · Last updated 12 Jun 2026

Brief summary (registry, in English)

The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 1 to 4 other available medications to prevent their migraines, but these medications have not helped them.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
874 (actual)
First submitted
15 Mar 2024
Start date
1 Apr 2024
Primary completion date
16 Jan 2026
Lead sponsor
H. Lundbeck A/S
Diseases
Migraine
NCT number
NCT06323928
EU CT number
2023-508821-28-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 874
  • From 1 Apr 2024 to the primary completion date, 16 Jan 2026
  • 129 sites in 14 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

  • The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (anti-PACAP treatment).

Other illness

  • The participant has confounding and clinically significant pain syndromes.
  • The participant has a diagnosis of acute or active temporomandibular disorder.

Other

  • The participant has a history or diagnosis of confounding headaches.
    • Additional protocol-defined criteria apply.

Who the study is looking for

  • The participant has a diagnosis of migraine as defined by International Classification of Headache Disorders Third Edition (ICHD-3) guidelines confirmed at the Screening Visit.
  • The participant has a history of migraine onset ≥ 12 months prior to the Screening Visit.
  • The participant has a migraine onset at ≤50 years of age.
  • The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
  • The participant has documented evidence of treatment failure in the past 10 years of at least 1 to 4 (maximum) different migraine preventive medications.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (129)

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

SiteCityCountrySite status
Medical Center Nevrocentrum EOOD
Coordinator of this site? Confirm its status
PlovdivBulgariaCompleted
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
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PlovdivBulgariaCompleted
Medical Center Rusemed EOOD
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RuseBulgariaCompleted
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaCompleted
Diagnostic And Consultative Center Neoclinic EAD
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SofiyaBulgariaCompleted
Universitetska Parva Mnogoprofilna Bolnitsa Za Aktivno Lechenie Sofia Sv. Yoan Krastitel
Coordinator of this site? Confirm its status
SofiyaBulgariaCompleted
Neurologie Rs Centrum s.r.o.
Coordinator of this site? Confirm its status
Hradec KraloveCzechiaCompleted
Neurosanatio s.r.o.
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Litomysl-MestoCzechiaCompleted
Neuros s.r.o.
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Plzen 3CzechiaCompleted
DADO MEDICAL s.r.o.
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PragueCzechiaCompleted
Praglandia s.r.o.
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PragueCzechiaCompleted
INEP medical s.r.o.
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PragueCzechiaCompleted
FORBELI s.r.o.
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PragueCzechiaCompleted
Clintrial s.r.o.
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Prague 10CzechiaCompleted
Axon Clinical s.r.o.
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Prague 5CzechiaCompleted
MP-neuro s.r.o.
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Slezká OstravaCzechiaCompleted
NeuroMed Zlin s.r.o.
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ZlínCzechiaCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Studienzentrum Dr. Bischof GmbH
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BoeblingenGermanyCompleted
Kopfschmerzzentrum Frankfurt
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Frankfurt am MainGermanyCompleted
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyCompleted
curiositas ad sanum Studien und Beratungs GmbH
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Haag I.obGermanyCompleted
Siteworks GmbH
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HanoverGermanyCompleted
Siteworks GmbH
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HeidelbergGermanyCompleted
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie
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KielGermanyCompleted
Copenhagen University Hospital
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Copenhagen NvDenmarkCompleted
Rigshospitalet
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GlostrupDenmarkCompleted
Hospital General Universitario Dr. Balmis
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AlicanteSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital del Mar
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BarcelonaSpainCompleted
Clinica Universidad de Navarra
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MadridSpainCompleted
Hospital Universitario HM Sanchinarro
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MadridSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
CHU Besancon
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Besancon CedexFranceCompleted
Hospices Civils de Lyon
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BronFranceCompleted
University Hospital Of Clermont-Ferrand
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Clermont Ferrand Cedex 1FranceCompleted
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceCompleted
Centre Hospitalier Regional De Marseille
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MarseilleFranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
Jo Ann Medical Center
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TbilisiGeorgiaUnknown status
S.Khechinashvili University Hospital
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TbilisiGeorgiaUnknown status
Caucasus Medical Center Ltd
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TbilisiGeorgiaUnknown status
MD Georgia Staff Physician MediClub Georgia
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TbilisiGeorgiaUnknown status
Aversi Clinic
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TbilisiGeorgiaUnknown status
JSC K. Eristavi National Center of Experimental and Clinical Surgery
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TbilisiGeorgiaUnknown status
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
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TbilisiGeorgiaUnknown status
Archangel St Michael Multiprofile Clinical Hospital
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TbilisiGeorgiaUnknown status
S-Medicon Kft.
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Budapest IVHungaryCompleted
Shonan Keiiku Hospital
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Fujisawa-shiJapanUnknown status
Saitama Medical University Hospital
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Iruma-gunJapanUnknown status
Tanaka Neurosurgery & Headache Clinic
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KagoshimaJapanUnknown status
Atsuchi Neurosurgical Hospital
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KagoshimaJapanUnknown status
Jinnouchi Neurosurgery Clinic
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Kasuga-shiJapanUnknown status
Ikeda Neurosurgery Clinic
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Kasuga-shiJapanUnknown status
Kitasato University Kitasato Institute Hospital
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Minato-kuJapanUnknown status
Shinagawa strings clinic
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Minato-KuJapanUnknown status
Mito Kyodo General Hospital
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MitoJapanUnknown status
Iwate Medical University Uchimaru Medical Center
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MoriokaJapanUnknown status
Tominaga Hospital
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OsakaJapanUnknown status
Nakamura Memorial Hospital
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SapporoJapanUnknown status
Sendai Headache and Neurology Clinic, Medical Corporation
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SendaiJapanUnknown status
Dokkyo Medical University Hospital
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Shimotsuga-gunJapanUnknown status
Japanese Red Cross Shizuoka Hospital
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ShizuokaJapanUnknown status
Keio University Hospital
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TokyoJapanUnknown status
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
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KaunasLithuaniaCompleted
Klaipedos universiteto ligonine VšĮ
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KlaipedaLithuaniaCompleted
Medicum Centrum UAB
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TaurageLithuaniaCompleted
Vilniaus universiteto ligonine Santaros klinikos VšĮ
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VilniusLithuaniaCompleted
Pratia S.A.
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BydgoszczPolandCompleted
Pratia S.A.
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CracowPolandCompleted
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
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ElblagPolandCompleted
Neuro-Care Sp. z o.o. sp.k.
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KatowicePolandCompleted
Specjalistyczne Gabinety Lekarskie Landa
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KrakówPolandCompleted
Centrum Opieki Zdrowotnej Orkan-Med Stec - Michalska Sp. j.
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KsawerówPolandCompleted
Appletreeclinics Network Sp. z o.o.
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LodzPolandCompleted
Centrum Medyczne Hope Clinic Sebastian Szklener
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LublinPolandCompleted
Indywidualna Praktyka Lekarska Dr hab. n. med. Anna Szczepanska-Szerej
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LublinPolandCompleted
Clinirem Sp. z o.o.
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LublinPolandCompleted
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
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Nowa SolPolandCompleted
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
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OswiecimPolandCompleted
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej
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PlewiskaPolandCompleted
Centrum Medyczne HCP Sp. z o.o.
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PoznanPolandCompleted
RCMed Oddzial Sochaczew
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SochaczewPolandCompleted
MTZ Clinical Research powered by Pratia
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WarsawPolandCompleted
Centrum Medyczne NeuroProtect
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WarsawPolandCompleted
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
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WrocławPolandCompleted
Clinhouse Sp. z o.o.
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ZabrzePolandCompleted
Fizio Center S.R.L.
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BucharestRomaniaCompleted
Policlinica CCBR S.R.L.
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BucharestRomaniaCompleted
Clubul Sanatatii S.R.L.
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CampulungRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
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ConstanțaRomaniaCompleted
MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o.
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Banská BystricaSlovakiaCompleted
IN MEDIC, s.r.o.
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BardejovSlovakiaCompleted
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas
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Liptovský MikulášSlovakiaCompleted
Konzilium s.r.o.
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Nova DubnicaSlovakiaCompleted
SANERA, s.r.o.
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PrešovSlovakiaCompleted
Univerzitna nemocnica Nemocnica svaeteho Michala a.s.
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Stare MestoSlovakiaCompleted
Accellacare and McFarland Clinic
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AmesUnited StatesUnknown status
Dent Neurosciences Research Center, Inc
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AmherstUnited StatesUnknown status
Internal Medicine and Pediatric Associates of Bristol, PC
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BristolUnited StatesUnknown status
Profound Research - Neurology Center of Southern California
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CarlsbadUnited StatesUnknown status
Accellacare of Cary - Cary Medical Group
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CaryUnited StatesUnknown status
Clinical Research Professionals
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ChesterfieldUnited StatesUnknown status
K2 Medical Research WINTER GARDEN
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ClermontUnited StatesUnknown status
Cedar Health Research, LLC
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DallasUnited StatesUnknown status
Neurology Center of North Orange County
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FullertonUnited StatesUnknown status
Headache Wellness Center
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GreensboroUnited StatesUnknown status
Healthcare Research Network
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HazelwoodUnited StatesUnknown status
Accel Research Sites Network - Neurology and Neurodiagnostic of Alabama
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HooverUnited StatesUnknown status
Clinical NeuroScience Solutions Inc
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JacksonvilleUnited StatesUnknown status
CenExel CNS
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Los AlamitosUnited StatesUnknown status
K2 Medical Research, LLC - Maitland
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MaitlandUnited StatesUnknown status
MedStar Health - Neurology Clinic at McLean
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McLeanUnited StatesUnknown status
Accellacare of Charleston
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Mt. PleasantUnited StatesUnknown status
Aqualane Clinical Research
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NaplesUnited StatesUnknown status
North Suffolk Neurology, PC
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Port Jefferson StationUnited StatesUnknown status
M3 Wake Research, Inc.
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RaleighUnited StatesUnknown status
Raleigh Medical Group
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RaleighUnited StatesUnknown status
Accellacare of Rocky Mount
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Rocky MountUnited StatesUnknown status
ASCLEPES Research Centers
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Sherman OaksUnited StatesUnknown status
Ki Health Partners, LLc, dba New England Institute for Clinical Research
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StamfordUnited StatesUnknown status
Mercury Clinical Research
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Sugar LandUnited StatesUnknown status
K2 Medical Research Tampa LLC
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TampaUnited StatesUnknown status
Premiere Research Institute Palm Beach
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West Palm BeachUnited StatesUnknown status
Triad Neurological Associates
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Winston-SalemUnited StatesUnknown status

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