A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

Last updated: March 24, 2025
Sponsor: Karuna Therapeutics
Overall Status: Active - Not Recruiting

Phase

3

Condition

Schizophrenia And Schizoaffective Disorders (Pediatric)

Schizotypal Personality Disorder (Spd)

Treatment

KarXT

Placebo

Clinical Study ID

NCT06126224
CN012-0027
KAR-032
CN012-0027
  • Ages 55-90
  • All Genders

Study Summary

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Is a male or female aged 55 to 90 years, inclusive, at Screening.

  2. Can understand the nature of the trial and protocol requirements and provideinformed consent or assent before any study assessments are performed.

  3. Meets clinical criteria for Possible AD or Probable AD.

  4. Living at the same home or residential assisted-living facility for a minimum of 6weeks before Screening.

  5. Have an identified study partner who should have daily contact (approximately 10hours a week or more).

  6. History of psychotic symptoms (meeting International Psychogeriatric Associationcriteria) (Cummings 2020) for at least 2 months prior to Screening.

  7. CGI-S scale with a score ≥ 4 at Screening and Baseline.

  8. AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline:

  9. Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2on 2 of the 8 items OR

  10. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domainscore of ≥ 2 on 2 of the 7 items

  11. MMSE score of 8 to 22, inclusive, at Screening.

Exclusion

Key Exclusion Criteria:

  1. Psychotic symptoms that are primarily attributable to a condition other than the ADcausing the dementia.

  2. History of major depressive episode with psychotic features during the 12 monthsprior to Screening.

  3. History of bipolar disorder, schizophrenia, or schizoaffective disorder.

  4. Significant or severe medical conditions including pulmonary, hepatic, renal,hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic,cardiovascular, or oncologic disease or any other condition that, in the opinion ofthe Investigator, could jeopardize the safety of the subject, ability to complete orcomply with the study procedures or validity of the study results.

  5. History or high risk of urinary retention, gastric retention, or narrow-angleglaucoma as evaluated by the Investigator.

  6. Prior exposure to KarXT.

  7. History of hypersensitivity to KarXT excipients or trospium chloride.

  8. Experienced any significant adverse events (AEs) due to trospium.

  9. Participation in another clinical study in which the subject received anexperimental or investigational drug within 3 months before Screening or hasparticipated in more than 2 clinical studies in the 12 months prior to Screening.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: KarXT
Phase: 3
Study Start date:
August 28, 2023
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, Limburg 3500
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  • Local Institution - 2801

    Hasselt, Limburg 3500
    Belgium

    Site Not Available

  • Local Institution - 2802

    Leuven, Vlaams Brabant 3000
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    Site Not Available

  • UZ Leuven

    Leuven, Vlaams Brabant 3000
    Belgium

    Active - Recruiting

  • AZ Delta- Campus Rumbeke

    Roeselare, West-Vlaanderen 8800
    Belgium

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    Roeselare, West-Vlaanderen 8800
    Belgium

    Site Not Available

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    Calgary, Alberta T2N 1N4
    Canada

    Site Not Available

  • Local Institution - 1603

    Hamilton, Ontario L8M 1W9
    Canada

    Site Not Available

  • Local Institution - 1602

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • Local Institution - 1604

    Whitby, Ontario L1N 5S9
    Canada

    Site Not Available

  • Local Institution - 1606

    Montreal, Quebec H4H 1R3
    Canada

    Site Not Available

  • Local Institution - 1601

    Verdun, Quebec H4H 1R3
    Canada

    Site Not Available

  • Biomedica Research Group

    Providencia, Metropolitana 7500000
    Chile

    Active - Recruiting

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    Providencia, Metropolitana 7500000
    Chile

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    Antofagasta, 1270244
    Chile

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    Antofagasta, 127-0244
    Chile

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    Antofagasta, 127-0244
    Chile

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    Las Condes, 7550000
    Chile

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    Las Condes, 7550000
    Chile

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    Hefei, Anhui 230022
    China

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    China

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    Beijing, Beijing 100088
    China

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    Beijing, Beijing 100088
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    Chongqing, Chongqing 400016
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    Chongqing, Chongqing 400016
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    Shenzhen, Guangdong 518118
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    China

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    China

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    Shanghai, Shanghai 200080
    China

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    Shanghai, Shanghai 200080
    China

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    China

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    China

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    Hangzhou, Zhejiang 310013
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    Hangzhou, Zhejiang 310003
    China

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    Hangzhou, Zhejiang 310016
    China

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    Hangzhou, Zhejiang 310016
    China

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    Hangzhou, Zhejiang 310003
    China

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    Wenzhou, Zhejiang 325000
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    Greece

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    Greece

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    Greece

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    Athina, Attiki 115 21
    Greece

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    Greece

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    Marousi, Attiki 151 23
    Greece

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    Greece

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    Greece

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  • Local Institution - 4801

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    Greece

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    Heraklion, 71110
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  • Local Institution - 4602

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    Miskolc, 3526
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    Daegu, Buk-gu 41404
    Korea, Republic of

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    Buk-gu, Daegu Gwang'yeogsi 41404
    Korea, Republic of

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  • Local Institution - 7207

    Seongnam-si, Gyeonggido 13496
    Korea, Republic of

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    Incheon, Incheon Gwang'yeogsi 21565
    Korea, Republic of

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  • Local Institution - 7205

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    Korea, Republic of

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    Incheon, Namdong-gu 21565
    Korea, Republic of

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  • Local Institution - 7204

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    Korea, Republic of

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  • Local Institution - 7202

    Seongnam-si, 0
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  • Seoul National University Bundang Hospital

    Seongnam-si, 0
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    Seoul, 143-729
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    Korea, Republic of

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    Seoul, 07071
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    Korea, Republic of

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    Seoul, 03080
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    Mexico

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    Saltillo Centro, Coahuila 25000
    Mexico

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    Saltillo Centro, Coahuila 25000
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    Monterrey, Nuevo LEON 64620
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  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo LEON 64460
    Mexico

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    Monterrey, Nuevo LEON 64460
    Mexico

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    Monterrey, Nuevo LEON 64620
    Mexico

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    Culiacan, Sinaloa 80020
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  • Neurociencias Estudios Clinicos S.C.

    Culiacan, Sinaloa 80020
    Mexico

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  • Health Pharma Professional Research-Av. Insurgente

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    Mexico, 03100
    Mexico

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    Miraflores, Lima 15046
    Peru

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  • Clinica Centenario Peruano Japonesa

    Pueblo Libre, Lima 15084
    Peru

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  • Local Institution - 6103

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    Peru

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    Callao, Callao 2
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    Bydgoszcz, Kujawsko-Pomorskie Województwo 85080
    Poland

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    Ścinawa, Lower Silesian 59330
    Poland

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  • Local Institution - 4206

    Lublin, Lubelskie 20-064
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  • NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska -Lublin

    Lublin, Lubelskie 20-064
    Poland

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  • AppleTreeClinics Network Sp. z o.o.

    Lodz, Lódzkie 90-349
    Poland

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    Lodz, Lódzkie 90-349
    Poland

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    Sopot, Pomorskie 81-855
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    Katowice, Silesian 40156
    Poland

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  • Clinical Medical Research sp. z o.o.

    Katowice, Slaskie 40-156
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    Katowice, Slaskie 40-156
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    Katowice, Slaskie 40-156
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  • Clinical Trial Site

    Łódź, Łódzkie Województwo 90349
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  • Local Institution - 4204

    Bydgoszcz, 85-080
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    Bydgoszcz, 85-080
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  • Osrodek Badawczo Naukowo Dydaktyczny Chorób Otepiennych im Ksiedza Henryka Kardynala Gulbinowicza

    Ścinawa, 59-330
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  • Local Institution - 4702

    Atakum, Samsun 55270
    Turkey

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  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

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    Turkey

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  • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

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    Turkey

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    Turkey

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  • Dokuz Eylul University Medical Faculty

    Izmir, 35210
    Turkey

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  • Izmir Ekonomi University Medical Point Hospital

    Izmir, 35575
    Turkey

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  • Local Institution - 4703

    Izmir, 35575
    Turkey

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    Izmir, 35210
    Turkey

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  • Local Institution - 2110

    Ilford, Greater London IG1 4HP
    United Kingdom

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    Swinton, Greater Manchester M27 8FF
    United Kingdom

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    London, Surrey SE5 8AZ
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    Aberdeen, AB25 2ZL
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    Chertsey, KT16 9AU
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    Edinburgh, EH4 2XU
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    Leeds, LS7 3JX
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    Motherwell, ML1 4UF
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    Preston, PR2 9HT
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    Sheffield, SouthYorkshire, s5 7JT
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  • Clinical Trial Site

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    United States

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    Chandler, Arizona 85286
    United States

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    Chandler, Arizona 85286
    United States

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    Encino, California 91316
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    Los Alamitos, California 90720
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    Los Alamitos, California 90720-6506
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    United States

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  • California Neuroscience Research - CenExel - PPDS

    Sherman Oaks, California 91403-2131
    United States

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    Sherman Oaks, California 91403
    United States

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    Sherman Oaks, California 91403-2131
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    Walnut Creek, California 94596
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    Walnut Creek, California 94596
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    Apopka, Florida 32703-5835
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    Clermont, Florida 34711
    United States

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    Clermont, Florida 34711-5190
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    Clermont, Florida 34711-5190
    United States

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    Clermont, Florida 34711-5190
    United States

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    Cutler Bay, Florida 33189
    United States

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    United States

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    Delray Beach, Florida 33445
    United States

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    Doral, Florida 33122
    United States

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    United States

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    United States

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    Fort Myers, Florida 33912
    United States

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    United States

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    Active - Recruiting

  • Galiz Research

    Hialeah, Florida 33016-1814
    United States

    Active - Recruiting

  • Local Institution - 1107

    Hialeah, Florida 33012-3618
    United States

    Site Not Available

  • Local Institution - 1120

    Hialeah, Florida 33012-4648
    United States

    Site Not Available

  • Local Institution - 1140

    Hialeah, Florida 33016-1814
    United States

    Site Not Available

  • Local Institution - 1155

    Hialeah, Florida 33012-3158
    United States

    Site Not Available

  • New Life Medical Research Center -3750 W 16th Ave

    Hialeah, Florida 33012-4648
    United States

    Active - Recruiting

  • Superior Associates in Research LLC

    Hialeah, Florida 33012-3158
    United States

    Active - Recruiting

  • Clinical Trial Site

    Hollywood, Florida 33020
    United States

    Site Not Available

  • Clinical Trial Site

    Homestead, Florida 33032
    United States

    Active - Recruiting

  • Local Institution - 0150

    Homestead, Florida 33032-8187
    United States

    Site Not Available

  • Local Institution - 1145

    Homestead, Florida 33032-8187
    United States

    Site Not Available

  • Sunbright Health Medical Center

    Homestead, Florida 33032-8187
    United States

    Active - Recruiting

  • Accel Research Sites - Saint Petersburg - Largo - ERN - PPDS

    Largo, Florida 33777-1359
    United States

    Active - Recruiting

  • Clinical Trial Site

    Largo, Florida 33777
    United States

    Active - Recruiting

  • Local Institution - 1127

    Largo, Florida 33777-1359
    United States

    Site Not Available

  • Clincloud Sandspur Office

    Maitland, Florida 32751-6138
    United States

    Active - Recruiting

  • Clinical Trial Site

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • K2 Medical Research - Maitland

    Maitland, Florida 32751-5669
    United States

    Active - Recruiting

  • Local Institution - 1039

    Maitland, Florida 32751-5669
    United States

    Site Not Available

  • Local Institution - 1146

    Maitland, Florida 32751-6138
    United States

    Site Not Available

  • Allied Biomedical Research Institute

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Angels Clinical Research Institute - Miami

    Miami, Florida 33122-1721
    United States

    Active - Recruiting

  • CCM Clinical Research Group

    Miami, Florida 33133-4231
    United States

    Active - Recruiting

  • Clinical Trial Site

    Miami, Florida 33145
    United States

    Active - Recruiting

  • Cordova Research Institute

    Miami, Florida 33155-6541
    United States

    Active - Recruiting

  • Dade Research Center

    Miami, Florida 33126-5683
    United States

    Active - Recruiting

  • Dade Research Center, LLC

    Miami, Florida 33126-5686
    United States

    Active - Recruiting

  • Florida Research Center, Inc.

    Miami, Florida 33174-2950
    United States

    Active - Recruiting

  • Floridian Neuroscience Institute-1901 SW 1 St

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Floridian Research Institute-1021 Ives Dairy Rd

    Miami, Florida 33179-2537
    United States

    Active - Recruiting

  • Future Care Solution LLC

    Miami, Florida 33165-3947
    United States

    Active - Recruiting

  • High Quality Research

    Miami, Florida 33184-1412
    United States

    Active - Recruiting

  • Homestead Associates in Research Inc

    Miami, Florida 33032
    United States

    Active - Recruiting

  • IMIC LLC- 9380 SW 150th Str

    Miami, Florida 33176-7947
    United States

    Active - Recruiting

  • Local Institution - 1009

    Miami, Florida 33155
    United States

    Site Not Available

  • Local Institution - 1105

    Miami, Florida 33179-2537
    United States

    Site Not Available

  • Local Institution - 1108

    Miami, Florida 33133-4231
    United States

    Site Not Available

  • Local Institution - 1109

    Miami, Florida 33174-2950
    United States

    Site Not Available

  • Local Institution - 1111

    Miami, Florida 33126-5683
    United States

    Site Not Available

  • Local Institution - 1113

    Miami, Florida 33155-6630
    United States

    Site Not Available

  • Local Institution - 1115

    Miami, Florida 33135
    United States

    Site Not Available

  • Local Institution - 1118

    Miami, Florida 33122-1721
    United States

    Site Not Available

  • Local Institution - 1125

    Miami, Florida 33135-1601
    United States

    Site Not Available

  • Local Institution - 1129

    Miami, Florida 33165-3947
    United States

    Site Not Available

  • Local Institution - 1143

    Miami, Florida 33145-2455
    United States

    Site Not Available

  • Local Institution - 1147

    Miami, Florida 33176-7947
    United States

    Site Not Available

  • Local Institution - 1150

    Miami, Florida 33165
    United States

    Site Not Available

  • Local Institution - 1157

    Miami, Florida 33184-1412
    United States

    Site Not Available

  • Local Institution - 1158

    Miami, Florida 33175
    United States

    Site Not Available

  • Local Institution - 1159

    Miami, Florida 33032
    United States

    Site Not Available

  • MedOne Clinical Research LLC

    Miami, Florida 33145-2455
    United States

    Active - Recruiting

  • My Community Research Center, Inc - 7480 Bird Rd

    Miami, Florida 33155-6630
    United States

    Active - Recruiting

  • My Community Research Center, Inc - 7480 Bird Rd Ste 400

    Miami, Florida 33155-6600
    United States

    Active - Recruiting

  • Reliant Medical Research

    Miami, Florida 33165
    United States

    Active - Recruiting

  • US Associates in Research Inc

    Miami, Florida 33175
    United States

    Active - Recruiting

  • Wellness Research Center Inc - Miami

    Miami, Florida 33135-1601
    United States

    Active - Recruiting

  • Clinical Trial Site

    Miami Gardens, Florida 33014
    United States

    Active - Recruiting

  • Local Institution - 1126

    Miami Gardens, Florida 33056-4000
    United States

    Site Not Available

  • New Med Research

    Miami Gardens, Florida 33056-4000
    United States

    Active - Recruiting

  • Clinical Trial Site

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Floridian Neuroscience Institute

    Miami Lakes, Florida 33016-1518
    United States

    Active - Recruiting

  • Local Institution - 1102

    Miami Lakes, Florida 33014-6435
    United States

    Site Not Available

  • Meridian International Research

    Miami Lakes, Florida 33014-6435
    United States

    Active - Recruiting

  • Clinical Trial Site

    Okeechobee, Florida 34972
    United States

    Active - Recruiting

  • Health Synergy Clinical Research

    Okeechobee, Florida 34972-2568
    United States

    Active - Recruiting

  • Local Institution - 1101

    Okeechobee, Florida 34972-2568
    United States

    Site Not Available

  • Clinical Trial Site

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Combined Research Orlando Phase I-IV LLC

    Orlando, Florida 32807-3555
    United States

    Active - Recruiting

  • Local Institution - 1112

    Orlando, Florida 32807-3555
    United States

    Site Not Available

  • Local Institution - 1136

    Orlando, Florida 32806-1041
    United States

    Site Not Available

  • PPD Clinical Research Unit Orlando

    Orlando, Florida 32806-1041
    United States

    Active - Recruiting

  • PPD Development, L.P.

    Orlando, Florida 32806-1041
    United States

    Active - Recruiting

  • Clinical Trial Site

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS

    Port Orange, Florida 32127-2914
    United States

    Active - Recruiting

  • Clinical Trial Site

    Port Orange, Florida 32127
    United States

    Active - Recruiting

  • Local Institution - 1137

    Port Orange, Florida 32127-2914
    United States

    Site Not Available

  • Cordova Research Institute- Sweetwater

    Sweetwater, Florida 33182
    United States

    Active - Recruiting

  • Local Institution - 1133

    Sweetwater, Florida 33182
    United States

    Site Not Available

  • Angels Clinical Research Institute Tampa

    Tampa, Florida 33614-2846
    United States

    Active - Recruiting

  • Clinical Trial Site

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Guardian Angel Research - ClinEdge - PPDS

    Tampa, Florida 33614-2700
    United States

    Active - Recruiting

  • Interventional Psychiatry of Tampa Bay

    Tampa, Florida 33629-5837
    United States

    Active - Recruiting

  • K2 Medical Research - Tampa

    Tampa, Florida 33607-4629
    United States

    Active - Recruiting

  • Local Institution - 1041

    Tampa, Florida 33607-4629
    United States

    Site Not Available

  • Local Institution - 1110

    Tampa, Florida 33629-5837
    United States

    Site Not Available

  • Local Institution - 1123

    Tampa, Florida 33614-2846
    United States

    Site Not Available

  • Local Institution - 1124

    Tampa, Florida 33614-2700
    United States

    Site Not Available

  • Local Institution - 1040

    The Villages, Florida 32159-8986
    United States

    Site Not Available

  • ClinCloud Clinical Research

    Viera, Florida 32940
    United States

    Active - Recruiting

  • Clinical Trial Site

    Viera, Florida 32940
    United States

    Active - Recruiting

  • Local Institution - 1131

    Viera, Florida 32940
    United States

    Site Not Available

  • Local Institution - 1152

    Augusta, Georgia 30912-0020
    United States

    Site Not Available

  • Local Institution - 1141

    Columbus, Georgia 31909-1693
    United States

    Site Not Available

  • Clinical Trial Site

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Local Institution - 1161

    Decatur, Georgia 30030
    United States

    Site Not Available

  • iResearch Atlanta - CenExel - PPDS

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Clinical Trial Site

    Elgin, Illinois 60123
    United States

    Active - Recruiting

  • Local Institution - 1148

    Elgin, Illinois 60123-9215
    United States

    Site Not Available

  • Revive Research Institute-Illinois

    Elgin, Illinois 60123-9215
    United States

    Active - Recruiting

  • Clinical Trial Site

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Legacy Clinical Solutions: Tandem Clinical Research LLC - Barataria Blvd - Marrero - ClinEdge - PPDS

    Marrero, Louisiana 70072-3083
    United States

    Active - Recruiting

  • Local Institution - 1114

    Marrero, Louisiana 70072-3083
    United States

    Site Not Available

  • Clinical Trial Site

    Rochester Hills, Michigan 48307
    United States

    Active - Recruiting

  • Local Institution - 1139

    Rochester Hills, Michigan 48307-2760
    United States

    Site Not Available

  • Revive Research Institute - 940 W Avon

    Rochester Hills, Michigan 48307-2760
    United States

    Active - Recruiting

  • Clinical Trial Site

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • Local Institution - 1132

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Precise Research Centers - ClinEdge - PPDS

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • Local Institution - 1144

    Las Vegas, Nevada 89106-4145
    United States

    Site Not Available

  • Local Institution - 1153

    New Hyde Park, New York 11042-2062
    United States

    Site Not Available

  • Local Institution - 1135

    Port Jefferson Station, New York 11776-3386
    United States

    Site Not Available

  • Clinical Trial Site

    Dayton, Ohio 45459
    United States

    Active - Recruiting

  • Local Institution - 1122

    Dayton, Ohio 45459-4248
    United States

    Site Not Available

  • Neurology Diagnostics - ERG - PPDS

    Dayton, Ohio 45459-4248
    United States

    Active - Recruiting

  • Local Institution - 1149

    Malvern, Pennsylvania 19355-3267
    United States

    Site Not Available

  • Clinical Trial Site

    Cypress, Texas 77429
    United States

    Active - Recruiting

  • Horizon Clinical Research: Gill Neuroscience

    Cypress, Texas 77429-6070
    United States

    Active - Recruiting

  • Local Institution - 1106

    Cypress, Texas 77429-6070
    United States

    Site Not Available

  • Clinical Trial Network - 7080 Southwest Fwy

    Houston, Texas 77074-2085
    United States

    Active - Recruiting

  • Local Institution - 1163

    Houston, Texas 77074-2085
    United States

    Site Not Available

  • Local Institution - 1154

    Katy, Texas 77450-1759
    United States

    Site Not Available

  • Mount Olympus Medical Research - Texas - Katy

    Katy, Texas 77450-1759
    United States

    Active - Recruiting

  • Olympus Research - Alcanza - HyperCore - PPDS

    Katy, Texas 77450-1759
    United States

    Active - Recruiting

  • Local Institution - 1121

    Red Oak, Texas 75154
    United States

    Site Not Available

  • Clinical Trial Site

    Stafford, Texas 77477
    United States

    Active - Recruiting

  • Local Institution - 1134

    Stafford, Texas 77477-3929
    United States

    Site Not Available

  • R & H Clinical Research-3727 Greenbriar Dr

    Stafford, Texas 77477-3929
    United States

    Active - Recruiting

  • Clinical Trial Site

    Sugar Land, Texas 77479
    United States

    Site Not Available

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