Clinical trial · NCT05980949 · RECRUITING · PHASE3

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Summary

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.

Interventions

KarXT · DRUG
KarXT 20/2 mg TID (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Must have completed study KAR-031 (CN012-0026), KAR-032(CN012-0027), or CN012-0056. This Inclusion criterion is not applicable for Protocol Amendment 07 or later versions.
* Can understand the nature of the study and protocol requirements and provide a signed informed consent (IC) form before any study assessments are performed. If the subject is deemed not competent to provide IC, both the following requirements for consent must be met:

1. The subject's legally acceptable representative (LAR) must provide IC
2. The subject must provide informed assent
* Must have stable living environment. At entry into this study, or any time during the study, if a subject needs to relocate from home, a residential assisted-living facility, or other stable location to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study.

Exclusion Criteria:

* Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.
* Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study KAR-031 (Visit 19), Study KAR-032 (Visit 12), Study CN012-0056 (Visit 12) that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.
* Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of KAR-033.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Sites (429)

Local Institution - 1029, Homewood, Alabama · WITHDRAWN
Local Institution - 1-13H98LK9, Chandler, Arizona · WITHDRAWN
Local Institution - 1227, Chandler, Arizona · WITHDRAWN
Local Institution - 1116, Chandler, Arizona · WITHDRAWN
Local Institution - 1247, Gilbert, Arizona · NOT_YET_RECRUITING
Local Institution - 1217, Phoenix, Arizona · NOT_YET_RECRUITING
Local Institution - 1044, Phoenix, Arizona · WITHDRAWN
Local Institution - 1220, Scottsdale, Arizona · WITHDRAWN
Advanced Research Center, Inc., Anaheim, California · RECRUITING
Local Institution - 1-141NO1DG, Chino, California · NOT_YET_RECRUITING
Local Institution - 1001, Costa Mesa, California · WITHDRAWN
Local Institution - 1151, Encino, California · WITHDRAWN
Local Institution - 1033, Encino, California · WITHDRAWN
Local Institution - 1031, Irvine, California · WITHDRAWN
Local Institution - 1142, Lancaster, California · WITHDRAWN
Local Institution - 1230, Long Beach, California · WITHDRAWN
Local Institution - 1117, Los Alamitos, California · WITHDRAWN
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC), Los Angeles, California · RECRUITING
Local Institution - 1228, Orange, California · NOT_YET_RECRUITING
SC3 Research - Pasadena - 960 E. Green St, Pasadena, California · RECRUITING
Local Institution - 1213, Rancho Cucamonga, California · NOT_YET_RECRUITING
Local Institution - 1103, Sherman Oaks, California · COMPLETED
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS, Walnut Creek, California · RECRUITING
Local Institution - 1014, Colorado Springs, Colorado · WITHDRAWN
University of Connecticut Health Center, Farmington, Connecticut · RECRUITING
Local Institution - 1013, Stamford, Connecticut · WITHDRAWN
Local Institution - 1225, Atlantis, Florida · WITHDRAWN
Local Institution - 1011, Boca Raton, Florida · WITHDRAWN
Envision Trials LLC, Bonita Springs, Florida · RECRUITING
Local Institution - 1015, Bradenton, Florida · WITHDRAWN
Local Institution - 1156, Clermont, Florida · WITHDRAWN
K2 Medical Research - Winter Garden, Clermont, Florida · RECRUITING
JY Research Institute Inc, Cutler Bay, Florida · RECRUITING
Arrow Clinical Trials, Daytona Beach, Florida · RECRUITING
Local Institution - 1224, Deerfield Beach, Florida · WITHDRAWN
Local Institution - 1162, Delray Beach, Florida · WITHDRAWN
Integrity Clinical Research LLC - 21st Street, Doral, Florida · RECRUITING
Betancourt Research Services, Doral, Florida · RECRUITING
Local Institution - 1165, Fort Myers, Florida · WITHDRAWN
Local Institution - 1155, Hialeah, Florida · COMPLETED
Direct Helpers Research Center, Hialeah, Florida · RECRUITING
New Life Medical Research Center -3750 W 16th Ave, Hialeah, Florida · RECRUITING
Local Institution - 1046, Hialeah, Florida · NOT_YET_RECRUITING
Las Mercedes Medical Research - 4440 West 16th Ave, Hialeah, Florida · RECRUITING
Local Institution - 1-13JED81K, Hialeah, Florida · WITHDRAWN
Local Institution - 1237, Hialeah, Florida · WITHDRAWN
Galiz Research, Hialeah, Florida · RECRUITING
Nexus Clinical Research Center- NRC, Homestead, Florida · RECRUITING
Local Institution - 1145, Homestead, Florida · WITHDRAWN
Coral Clinic Research, Homestead, Florida · RECRUITING
Homestead Associates in Research Inc-30328 Old Dixie Hwy, Homestead, Florida · RECRUITING
Local Institution - 1127, Largo, Florida · WITHDRAWN
K2 Medical Research - Maitland, Maitland, Florida · RECRUITING
Local Institution - 1146, Maitland, Florida · WITHDRAWN
Premier Clinical Research Institute, Miami, Florida · RECRUITING
Angels Clinical Research Institute - Miami, Miami, Florida · RECRUITING
Local Institution - 1005, Miami, Florida · NOT_YET_RECRUITING
CCM Clinical Research Group, Miami, Florida · RECRUITING
Wellness Research Center Inc - Miami, Miami, Florida · RECRUITING
A & D Doctor Center, Miami, Florida · RECRUITING
Floridian Neuroscience Institute-1901 SW 1 St, Miami, Florida · RECRUITING
Local Institution - 1010, Miami, Florida · WITHDRAWN
MedOne Clinical Research LLC, Miami, Florida · RECRUITING
Allied Biomedical Research Institute, Miami, Florida · RECRUITING
My Community Research Center, Inc - 7480 Bird Rd, Miami, Florida · RECRUITING
Future Care Solution LLC, Miami, Florida · RECRUITING
Reliant Medical Research, Miami, Florida · RECRUITING
South Florida Research Phase I-IV, Inc. - Miami, Miami, Florida · RECRUITING
Novel Clinical Research Center, LLC -7000 SW 97th Ave, Miami, Florida · RECRUITING
Dade Research Center - Miami FL - 7600 SW 87th Ave, Miami, Florida · RECRUITING
Florida Research Center, Inc., Miami, Florida · RECRUITING
Local Institution - 1158, Miami, Florida · COMPLETED
Serenity Research Center, Miami, Florida · RECRUITING
IMIC LLC- 9380 SW 150th Str, Miami, Florida · RECRUITING
New Gen Health, Miami, Florida · RECRUITING
Local Institution - 1105, Miami, Florida · COMPLETED
High Quality Research, Miami, Florida · RECRUITING
Coral Research Clinic & Coral Diagnostic Center, Miami, Florida · RECRUITING
ONHEALTH Research Center, Miami, Florida · RECRUITING
New Med Research, Miami Gardens, Florida · RECRUITING
San Marcus Research Clinic Inc, Miami Lakes, Florida · RECRUITING
Meridian International Research, Miami Lakes, Florida · RECRUITING
Local Institution - 1209, Miami Lakes, Florida · WITHDRAWN
Ocean Blue Medical Research Center Inc, Miami Springs, Florida · RECRUITING
Local Institution - 1246, Naples, Florida · NOT_YET_RECRUITING
Local Institution - 1212, Ocoee, Florida · NOT_YET_RECRUITING
Local Institution - 1101, Okeechobee, Florida · WITHDRAWN
Nova Psychiatry, Orlando, Florida · RECRUITING
Local Institution - 1136, Orlando, Florida · WITHDRAWN
Combined Research Orlando Phase I-IV LLC, Orlando, Florida · RECRUITING
Neurology Associates of Ormond Beach, Ormond Beach, Florida · RECRUITING
Local Institution - 1012, Pensacola, Florida · WITHDRAWN
Local Institution - 1137, Port Orange, Florida · WITHDRAWN
Local Institution - 1205, Port Orange, Florida · WITHDRAWN
Local Institution - 1008, St. Petersburg, Florida · WITHDRAWN
Local Institution - 1133, Sweetwater, Florida · COMPLETED
Local Institution - 1041, Tampa, Florida · NOT_YET_RECRUITING
Angels Clinical Research Institute Tampa - Palm Springs - PPDS, Tampa, Florida · RECRUITING
Guardian Angel Research, Tampa, Florida · RECRUITING
Interventional Psychiatry of Tampa Bay, Tampa, Florida · RECRUITING
Local Institution - 1040, The Villages, Florida · WITHDRAWN
Local Institution - 1131, Viera, Florida · WITHDRAWN
Premiere Research Institute at Palm Beach Neurology, PA, West Palm Beach, Florida · RECRUITING
Agile Clinical Research Trials, LLC, Atlanta, Georgia · RECRUITING
Local Institution - 1161, Decatur, Georgia · WITHDRAWN
Local Institution - 1037, Berwyn, Illinois · WITHDRAWN
Local Institution - 1148, Elgin, Illinois · WITHDRAWN
Local Institution - 1114, Marrero, Louisiana · WITHDRAWN
Local Institution - 1223, Belmont, Massachusetts · NOT_YET_RECRUITING
Local Institution - 1245, Boston, Massachusetts · NOT_YET_RECRUITING
Local Institution - 1243, North Dartmouth, Massachusetts · NOT_YET_RECRUITING
Local Institution - 1239, Springfield, Massachusetts · NOT_YET_RECRUITING
Local Institution - 1-146Y4PVY, Bloomfield Township, Michigan · WITHDRAWN
Local Institution - 1248, Bloomfield Township, Michigan · NOT_YET_RECRUITING
Local Institution - 1139, Rochester Hills, Michigan · WITHDRAWN
Precise Research Centers, Flowood, Mississippi · RECRUITING
Local Institution - 1255, St Louis, Missouri · NOT_YET_RECRUITING
Local Institution - 1202, Toms River, New Jersey · NOT_YET_RECRUITING
Local Institution - 1232, Toms River, New Jersey · WITHDRAWN
Local Institution - 1018, Manhasset, New York · WITHDRAWN
Local Institution - 1017, New York, New York · WITHDRAWN
Local Institution - 1034, Stony Brook, New York · WITHDRAWN
Local Institution - 1231, Syracuse, New York · WITHDRAWN
Local Institution - 1240, Syracuse, New York · NOT_YET_RECRUITING
Five Towns Neurology PC -Woodmere - 923 Broadway, Woodmere, New York · RECRUITING
Local Institution - 1221, Greensboro, North Carolina · NOT_YET_RECRUITING
AMC Research, LLC - Flourish - PPDS, Matthews, North Carolina · RECRUITING
Local Institution - 1215, Morehead City, North Carolina · NOT_YET_RECRUITING
Local Institution - 1252, Shelby, North Carolina · NOT_YET_RECRUITING
Local Institution - 1201, Columbus, Ohio · NOT_YET_RECRUITING
Local Institution - 1122, Dayton, Ohio · WITHDRAWN
Local Institution - 1249, Shaker Heights, Ohio · NOT_YET_RECRUITING
Local Institution - 1016, Oklahoma City, Oklahoma · NOT_YET_RECRUITING
Local Institution - 1218, Providence, Rhode Island · WITHDRAWN
Local Institution - 1035, Charleston, South Carolina · WITHDRAWN
Local Institution - 1211, Nashville, Tennessee · WITHDRAWN
Horizon Clinical Research: Gill Neuroscience, Cypress, Texas · RECRUITING
Local Institution - 1121, DeSoto, Texas · NOT_YET_RECRUITING
Local Institution - 1208, El Paso, Texas · NOT_YET_RECRUITING
Local Institution - 1022, Flower Mound, Texas · WITHDRAWN
Local Institution - 1036, Frisco, Texas · WITHDRAWN
Clinical Trial Network - 7080 Southwest Fwy, Houston, Texas · RECRUITING
Local Institution - 1238, Plano, Texas · WITHDRAWN
Local Institution - 1210, San Antonio, Texas · NOT_YET_RECRUITING
Local Institution - 1134, Stafford, Texas · WITHDRAWN
Local Institution - 1241, Arlington, Virginia · NOT_YET_RECRUITING
Local Institution - 1254, Kirkland, Washington · NOT_YET_RECRUITING
Local Institution - 5004, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina · NOT_YET_RECRUITING
Local Institution - 5009, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina · NOT_YET_RECRUITING
Local Institution - 5005, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina · NOT_YET_RECRUITING
Local Institution - 5001, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina · NOT_YET_RECRUITING
Local Institution - 5008, Rosario, Santa Fe Province, Argentina · NOT_YET_RECRUITING
Local Institution - 5002, Buenos Aires, Argentina · NOT_YET_RECRUITING
Local Institution - 5006, Buenos Aires, Argentina · NOT_YET_RECRUITING
Local Institution - 5007, Córdoba, Argentina · NOT_YET_RECRUITING
Local Institution - 5003, Córdoba, Argentina · NOT_YET_RECRUITING
Local Institution - 2806, Jette, Brussels Capital, Belgium · NOT_YET_RECRUITING
Local Institution - 2801, Hasselt, Limburg, Belgium · WITHDRAWN
Local Institution - 2802, Leuven, Vlaams Brabant, Belgium · WITHDRAWN
Local Institution - 2803, Roeselare, West-Vlaanderen, Belgium · NOT_YET_RECRUITING
Local Institution - 1-13JED87R, Alken, Belgium · WITHDRAWN
Local Institution - 2804, Alken, Belgium · COMPLETED
Local Institution - 2805, Kortrijk, Belgium · NOT_YET_RECRUITING
Local Institution - 1-13J38ZST, Brasília, Federal District, Brazil · WITHDRAWN
Local Institution - 6201, Brasília, Federal District, Brazil · NOT_YET_RECRUITING
CPQuali Pesquisa Clínica Sao Paulo, São Paulo, São Paulo, Brazil · RECRUITING
Local Institution - 1-13J38ZS5, São Paulo, São Paulo, Brazil · WITHDRAWN
BR Trials - Pesquisa Clínica, São Paulo, São Paulo, Brazil · RECRUITING
Local Institution - 1-13J38ZTW, São Paulo, São Paulo, Brazil · WITHDRAWN
Local Institution - 6207, São Paulo, São Paulo, Brazil · NOT_YET_RECRUITING
Local Institution - 1-13J38ZSH, São Paulo, São Paulo, Brazil · WITHDRAWN
Local Institution - 1-13J38ZRS, São Paulo, São Paulo, Brazil · WITHDRAWN
Local Institution - 6203, São Paulo, São Paulo, Brazil · NOT_YET_RECRUITING
Local Institution - 1-13J338E3, Rio de Janeiro, Brazil · WITHDRAWN
Ruschel Medicina, Rio de Janeiro, Brazil · RECRUITING
Instituto de Psiquiatria HC FMUSP, São Paulo, Brazil · RECRUITING
Local Institution - 4505, Sofia, Sofia-Grad, Bulgaria · WITHDRAWN
Local Institution - 4502, Sofia, Sofia-Grad, Bulgaria · WITHDRAWN
Local Institution - 4506, Sofia, Sofia-Grad, Bulgaria · NOT_YET_RECRUITING
Medical Center Medconsult Pleven OOD, Pleven, Bulgaria · RECRUITING
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-66 Peshtersko Shosse blvd, Plovdiv, Bulgaria · RECRUITING
University Multiprofile Hospital For Active Treatment Kanev AD, Rousse, Bulgaria · RECRUITING
Medical Center Sveti Naum EOOD, Sofia, Bulgaria · RECRUITING
Local Institution - 4509, Sofia, Bulgaria · NOT_YET_RECRUITING
Local Institution - 1-12IRCCNP, Calgary, Alberta, Canada · WITHDRAWN
Local Institution - 1603, Hamilton, Ontario, Canada · WITHDRAWN
Local Institution - 1604, Whitby, Ontario, Canada · WITHDRAWN
Local Institution - 1-12IYJCH7, Montreal, Quebec, Canada · WITHDRAWN
Local Institution - 1601, Verdun, Quebec, Canada · WITHDRAWN
Biomedica Research Group, Providencia, Santiago Metropolitan, Chile · RECRUITING
Psicomed Estudios Medicos, Antofagasta, Chile · RECRUITING
Especialidades Medicas L Y S, Las Condes, Chile · RECRUITING
Local Institution - 7007, Hefei, Anhui, China · WITHDRAWN
Local Institution - 7004, Beijing, Beijing Municipality, China · WITHDRAWN
Beijing Anding Hospital Capital Medical University, Beijing, Beijing Municipality, China · RECRUITING
Local Institution - 7025, Beijing, Beijing Municipality, China · NOT_YET_RECRUITING
Local Institution - 7015, Chongqing, Chongqing Municipality, China · WITHDRAWN
The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China · RECRUITING
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China · RECRUITING
Local Institution - 7009, Guangzhou, Guangdong, China · WITHDRAWN
Shenzhen Kangning Hospital, Shenzhen, Guangdong, China · RECRUITING
Local Institution - 7014, Nanjing, Jiangsu, China · WITHDRAWN
The Second Affiliated Hospital of Nanjing Medical University - Main Campus, Nanjing, Jiangsu, China · RECRUITING
Local Institution - 7024, Nanjing, Jiangsu, China · NOT_YET_RECRUITING
Local Institution - 7023, Zhenjiang, Jiangsu, China · NOT_YET_RECRUITING
Local Institution - 7012, Nanchang, Jiangxi, China · WITHDRAWN
Local Institution - 1-14J7PZ32, Xi'an, Shan1xi, China · NOT_YET_RECRUITING
Shanghai Mental Health Center - PPDS, Shanghai, Shanghai Municipality, China · RECRUITING
Local Institution - 7028, Shanghai, Shanghai Municipality, China · NOT_YET_RECRUITING
Local Institution - 7011, Shanghai, Shanghai Municipality, China · WITHDRAWN
Local Institution - 7026, Shanghai, Shanghai Municipality, China · NOT_YET_RECRUITING
West China Hospital Sichuan University, Chengdu, Sichuan, China · RECRUITING
Tianjin Anding Hospital(Tianjin mental Health Center), Tianjin, Tianjin Municipality, China · RECRUITING
Local Institution - 7017, Hangzhou, Zhejiang, China · WITHDRAWN
Local Institution - 7010, Hangzhou, Zhejiang, China · WITHDRAWN
Local Institution - 7021, Hangzhou, Zhejiang, China · NOT_YET_RECRUITING
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China · RECRUITING
Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus, Hangzhou, Zhejiang, China · RECRUITING
Local Institution - 7018, Wenzhou, Zhejiang, China · WITHDRAWN
Local Institution - 7027, Changsha, China · NOT_YET_RECRUITING
Local Institution - 7022, Kunming, China · NOT_YET_RECRUITING
Klinicki Bolnicki Centar Zagreb, Zagreb, City of Zagreb, Croatia · RECRUITING
Local Institution - 1-140R4546, Zagreb, City of Zagreb, Croatia · WITHDRAWN
Local Institution - 4102, Zagreb, City of Zagreb, Croatia · NOT_YET_RECRUITING
Local Institution - 4103, Zagreb, City of Zagreb, Croatia · WITHDRAWN
Local Institution - 4106, Zagreb, City of Zagreb, Croatia · NOT_YET_RECRUITING
Klinika za psihijatriju Vrapce, Zagreb, City of Zagreb, Croatia · RECRUITING
Local Institution - 4104, Zagreb, City of Zagreb, Croatia · NOT_YET_RECRUITING
CLINTRIAL s.r.o., Prague, Praha, Hlavní Mesto, Czechia · RECRUITING
Neuroterapie KH, s.r.o, Kutná Hora, Czechia · RECRUITING
A-SHINE s.r.o., Pilsen, Czechia · RECRUITING
Local Institution - 4004, Prague, Czechia · WITHDRAWN
Local Institution - 4006, Rychnov nad Kněžnou, Czechia · NOT_YET_RECRUITING
Local Institution - 2510, Nice, Alpes-Maritimes, France · WITHDRAWN
Local Institution - 2511, Tours, Indre-et-Loire, France · NOT_YET_RECRUITING
Local Institution - 2501, Reims, Marne, France · WITHDRAWN
Centre Hospitalier Universitaire Hopitaux de Rouen-1 Rue de Germont, Rouen, Seine-Maritime, France · RECRUITING
Local Institution - 2513, Toulouse, France · NOT_YET_RECRUITING
Local Institution - 2401, Böblingen, Baden-Wurttemberg, Germany · WITHDRAWN
Local Institution - 2407, Böblingen, Baden-Wurttemberg, Germany · NOT_YET_RECRUITING
Local Institution - 2403, Bayreuth, Bavaria, Germany · WITHDRAWN
Local Institution - 1-13JED8BL, Erbach im Odenwald, Hesse, Germany · WITHDRAWN
Local Institution - 2402, Homburg, Saarland, Germany · WITHDRAWN
Local Institution - 2404, Erbach im Odenwald, Germany · NOT_YET_RECRUITING
Local Institution - 1-13JED842, Frankfurt am Main, Germany · WITHDRAWN
Local Institution - 2405, Frankfurt am Main, Germany · NOT_YET_RECRUITING
Local Institution - 4805, Athens, Attica, Greece · WITHDRAWN
Local Institution - 4803, Athens, Attica, Greece · WITHDRAWN
Local Institution - 4802, Chaidari, Athens, Attica, Greece · WITHDRAWN
Local Institution - 4810, Kalyftaki-N. Kifissia, Attica, Greece · WITHDRAWN
Local Institution - 4806, Marousi, Attica, Greece · WITHDRAWN
University General Hospital of Heraklion, Heraklion, Greece · RECRUITING
Local Institution - 4811, Thessaloniki, Greece · WITHDRAWN
Local Institution - 4601, Pécs, Baranya, Hungary · NOT_YET_RECRUITING
Local Institution - 1-13JED893, Szeged, Csongrád megye, Hungary · WITHDRAWN
Local Institution - 4610, Szeged, Csongrád megye, Hungary · WITHDRAWN
Local Institution - 4602, Budapest, Hungary · NOT_YET_RECRUITING
Local Institution - 4612, Budapest, Hungary · NOT_YET_RECRUITING
Local Institution - 1-13JED8D1, Gyöngyös, Hungary · WITHDRAWN
Local Institution - 4611, Gyöngyös, Hungary · NOT_YET_RECRUITING
Local Institution - 4603, Miskolc, Hungary · WITHDRAWN
Local Institution - 7401, Nagpur, Maharashtra, India · NOT_YET_RECRUITING
Local Institution - 7405, Chandigarh, Punjab, India · NOT_YET_RECRUITING
Local Institution - 7406, Ajmer, Rajasthan, India · NOT_YET_RECRUITING
Local Institution - 7403, Hyderabad, India · NOT_YET_RECRUITING
Local Institution - 7404, Kolkata, India · NOT_YET_RECRUITING
Local Institution - 7402, Varanasi, India · NOT_YET_RECRUITING
Local Institution - 3101, Jerusalem, Jerusalem, Israel · NOT_YET_RECRUITING
Local Institution - 3103, Ashkelon, Tel Aviv, Israel · NOT_YET_RECRUITING
Local Institution - 3102, Petah Tikva, Israel · NOT_YET_RECRUITING
Local Institution - 3104, Ramat Gan, Israel · NOT_YET_RECRUITING
Local Institution - 1-140JNJT7, Salerno, Campania, Italy · WITHDRAWN
Local Institution - 1-13JED80W, Rome, Lazio, Italy · WITHDRAWN
Local Institution - 2322, Rome, Lazio, Italy · NOT_YET_RECRUITING
Local Institution - 1-13JED82O, Rome, Lazio, Italy · WITHDRAWN
Local Institution - 2320, Rome, Lazio, Italy · WITHDRAWN
Local Institution - 2301, Rome, Lazio, Italy · WITHDRAWN
Local Institution - 1-13JED83E, Brescia, Lombardy, Italy · WITHDRAWN
Local Institution - 2324, Brescia, Lombardy, Italy · NOT_YET_RECRUITING
Local Institution - 2304, Milan, Lombardy, Italy · WITHDRAWN
Local Institution - 2323, Milan, Lombardy, Italy · NOT_YET_RECRUITING
Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena, Baggiovara, Modena, Italy · RECRUITING
Local Institution - 2307, Ponderano (Biella), Piedmont, Italy · NOT_YET_RECRUITING
Local Institution - 2321, Rome, Roma, Italy · WITHDRAWN
Local Institution - 2308, Florence, Tuscany, Italy · WITHDRAWN
Local Institution - 2305, Monza, Italy · WITHDRAWN
Local Institution - 2302, Pisa, Italy · WITHDRAWN
Local Institution - 2303, Roma, Italy · NOT_YET_RECRUITING
Local Institution - 2309, Roma, Italy · NOT_YET_RECRUITING
Local Institution - 1-13H98LYW, Iizuka, Fukuoka, Japan · WITHDRAWN
Local Institution - 7503, Iizuka, Fukuoka, Japan · WITHDRAWN
Local Institution - 7525, Kōriyama, Fukushima, Japan · NOT_YET_RECRUITING
Local Institution - 7522, Sapporo, Hokkaido, Japan · NOT_YET_RECRUITING
Local Institution - 7526, Himeji-Shi, Hyōgo, Japan · NOT_YET_RECRUITING
Local Institution - 1-13H98LIT, Toride-shi, Ibaraki, Japan · WITHDRAWN
Memory Clinic Toride, Toride-shi, Ibaraki, Japan · RECRUITING
Local Institution - 7514, Takamatsu, Kagawa-ken, Japan · NOT_YET_RECRUITING
Local Institution - 7505, Hadano, Kanagawa, Japan · NOT_YET_RECRUITING
Koukan Clinic, Kawasaki-Shi, Kanagawa, Japan · RECRUITING
Local Institution - 7520, Yokohama, Kanagawa, Japan · NOT_YET_RECRUITING
Yokohama City Minato Red Cross Hospital, Yokohama, Kanagawa, Japan · RECRUITING
Yokohama City University Hospital, Yokohama, Kanagawa, Japan · RECRUITING
National Hospital Organization Utano National Hospital, Kyoto, Kyoto, Japan · RECRUITING
Local Institution - 7506, Tsu, Mie-ken, Japan · NOT_YET_RECRUITING
Asakayama General Hospital, Sakai, Osaka, Japan · RECRUITING
Local Institution - 7501, Takatsuki, Osaka, Japan · NOT_YET_RECRUITING
Local Institution - 7512, Yoshinogawa, Tokushima, Japan · NOT_YET_RECRUITING
Local Institution - 7518, Hachiōji, Tokyo, Japan · NOT_YET_RECRUITING
Local Institution - 7521, Setagaya-Ku, Tokyo, Japan · NOT_YET_RECRUITING
Kurumi Clinic, Setagaya-Ku, Tokyo, Japan · RECRUITING
Local Institution - 7528, Setagaya-Ku, Tokyo, Japan · NOT_YET_RECRUITING
Local Institution - 7527, tabashi City, Tokyo, Japan · NOT_YET_RECRUITING
Funairi nou clinic, Hiroshima, Japan · RECRUITING
Local Institution - 1-13H98LTZ, Kumamoto, Japan · NOT_YET_RECRUITING
Local Institution - 7524, Kumamoto, Japan · NOT_YET_RECRUITING
Local Institution - 7523, Tatebayashi, Japan · NOT_YET_RECRUITING
Hospital Universitario de Saltillo Dr Gonzalo Valdes Valdes, Saltillo Centro, Coahuila, Mexico · RECRUITING
Local Institution - 1504, Zona Urbana Río Tijuana, Estado de Baja California, Mexico · WITHDRAWN
Local Institution - 1507, Zapopan, Jalisco, Mexico · WITHDRAWN
Hospital Universitario Dr. Jose Eleuterio González, Monterrey, Nuevo León, Mexico · RECRUITING
Local Institution - 1505, Monterrey, Nuevo León, Mexico · WITHDRAWN
Neurociencias Estudios Clinicos S.C., Culiacán, Sinaloa, Mexico · RECRUITING
Local Institution - 1506, México, Mexico · WITHDRAWN
Local Institution - 6102, Miraflores, Lima region, Peru · WITHDRAWN
Local Institution - 6101, Callao, Peru · WITHDRAWN
Centrum Medyczne HCP Szpital im. Jana Pawla II, Poznan, Greater Poland Voivodeship, Poland · RECRUITING
Osrodek Badan Klinicznych Appletreeclinics, Lódz, Lódzkie, Poland · RECRUITING
Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17, Gdansk, Pomeranian Voivodeship, Poland · RECRUITING
Local Institution - 1-13JAX170, Gdansk, Pomeranian Voivodeship, Poland · WITHDRAWN
Local Institution - 4215, Iława, Warmian-Masurian Voivodeship, Poland · NOT_YET_RECRUITING
Local Institution - 4204, Bydgoszcz, Poland · WITHDRAWN
Local Institution - 4208, Katowice, Poland · WITHDRAWN
Local Institution - 4205, Katowice, Poland · WITHDRAWN
Local Institution - 4213, Kielce, Poland · WITHDRAWN
Medycyna Milorzab sp. z o.o., Lodz, Poland · RECRUITING
Pro Salus Sp. z o.o.,sp. k., Lodz, Poland · RECRUITING
NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska -Lublin, Lublin, Poland · RECRUITING
Local Institution - 4209, Siemianowice Śląskie, Poland · WITHDRAWN
Local Institution - 4216, Sochaczew, Poland · NOT_YET_RECRUITING
Osrodek Badawczo Naukowo Dydaktyczny Chorób Otepiennych im Ksiedza Henryka Kardynala Gulbinowicza, Ścinawa, Poland · RECRUITING
Local Institution - 4211, Wroclaw, Poland · WITHDRAWN
Local Institution - 2701, Guimarães, Braga District, Portugal · WITHDRAWN
Local Institution - 2704, Lisbon, Lisbon District, Portugal · WITHDRAWN
Local Institution - 2702, Torres Vedras, Lisbon District, Portugal · WITHDRAWN
Local Institution - 2703, Matosinhos Municipality, Porto District, Portugal · WITHDRAWN
Local Institution - 2705, Lisbon, Portugal · NOT_YET_RECRUITING
Local Institution - 2706, Lisbon, Portugal · WITHDRAWN
Local Institution - 1303, Bayamón, Puerto Rico · WITHDRAWN
Local Institution - 1301, Bayamón, Puerto Rico · WITHDRAWN
Local Institution - 1305, Carolina, Puerto Rico · WITHDRAWN
Local Institution - 1302, San Juan, Puerto Rico · NOT_YET_RECRUITING
Barbara Diaz Hernandez MD Research Inc, San Juan, Puerto Rico · RECRUITING
CMI Dr. Buhas Ramocea Elena Daniela - Cabinet Medical de Psihiarie, Oradea, Bihor County, Romania · RECRUITING
Local Institution - 1-14JIMILF, Bucharest, Romania · NOT_YET_RECRUITING
Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala, Bucharest, Romania · RECRUITING
Local Institution - 4902, Constanța, Romania · NOT_YET_RECRUITING
Local Institution - 4903, Craiova, Romania · NOT_YET_RECRUITING
S.C. Carpe Diem SRL, Sibiu, Romania · RECRUITING
Local Institution - 4307, Belgrade, Belgrade, Serbia · WITHDRAWN
Local Institution - 4302, Belgrade, Belgrade, Serbia · NOT_YET_RECRUITING
Clinical Hospital Center Dragisa Misovic Dedinje, Belgrade, Serbia · RECRUITING
Local Institution - 4308, Belgrade, Serbia · NOT_YET_RECRUITING
Military Medical Academy, Belgrade, Serbia · RECRUITING
Local Institution - 1-13JAX17Q, Gornja Toponica, Serbia · WITHDRAWN
Special Hospital for Psychiatric Diseases "Gornja Toponica", Gornja Toponica, Serbia · RECRUITING
Special Hospital for Psychiatric Diseases Kovin, Kovin, Serbia · RECRUITING
Local Institution - 4301, Kragujevac, Serbia · NOT_YET_RECRUITING
Local Institution - 4310, Kragujevac, Serbia · NOT_YET_RECRUITING
University Clinical Center Kragujevac, Kragujevac, Serbia · RECRUITING
Local Institution - 4309, Novi Sad, Serbia · NOT_YET_RECRUITING
Local Institution - 4311, Vršac, Serbia · WITHDRAWN
Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43, Košice, Košice Region, Slovakia · RECRUITING
MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o., Banská Bystrica, Slovakia · RECRUITING
KONZILIUM s.r.o, Dubnica nad Váhom, Slovakia · RECRUITING
EPAMED s.r.o, Košice, Slovakia · RECRUITING
Local Institution - 1-13JED85D, Pezinok, Slovakia · WITHDRAWN
Local Institution - 4407, Pezinok, Slovakia · COMPLETED
Crystal Comfort, s.r.o., Vranov nad Topľou, Slovakia · RECRUITING
Local Institution - 7208, Buk-gu, Daegu Gwang'yeogsi, South Korea · WITHDRAWN
Local Institution - 7214, Ansan-si, Gyeonggido, South Korea · NOT_YET_RECRUITING
Local Institution - 7207, Seongnam-si, Gyeonggido, South Korea · WITHDRAWN
Local Institution - 7216, Yongin-si, Gyeonggido, South Korea · NOT_YET_RECRUITING
Local Institution - 7205, Incheon, Incheon Gwang'yeogsi, South Korea · WITHDRAWN
Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, South Korea · RECRUITING
Local Institution - 7217, Seoul, Seoul Teugbyeolsi, South Korea · NOT_YET_RECRUITING
Local Institution - 7213, Seoul, Seoul Teugbyeolsi, South Korea · NOT_YET_RECRUITING
Ewha Womans University Mokdong Hospital, Seoul, Seoul Teugbyeolsi, South Korea · RECRUITING
The Catholic University of Korea, Yeouido St. Mary's Hospital, Yeongdeungpo-gu, Seoul Teugbyeolsi, South Korea · RECRUITING
Hallym University Chuncheon Sacred Heart Hospital, Gangwon-do, South Korea · RECRUITING
Local Institution - 7202, Seongnam-si, South Korea · WITHDRAWN
Local Institution - 7219, Seoul, South Korea · NOT_YET_RECRUITING
Local Institution - 7203, Seoul, South Korea · WITHDRAWN
Local Institution - 7201, Seoul, South Korea · WITHDRAWN
Hanyang University Seoul Hospital, Seoul, South Korea · RECRUITING
Local Institution - 7210, Seoul, South Korea · NOT_YET_RECRUITING
Local Institution - 2211, Majadahonda, Madrid, Spain · NOT_YET_RECRUITING
Local Institution - 2213, Málaga, Málaga, Spain · NOT_YET_RECRUITING
Local Institution - 2205, Barcelona, Spain · WITHDRAWN
Local Institution - 2212, Lleida, Spain · WITHDRAWN
Local Institution - 2207, Madrid, Spain · WITHDRAWN
Hospital Clinico San Carlos, Madrid, Spain · RECRUITING
Complejo Asistencial Universitario de Salamanca - H. Clinico, Salamanca, Spain · RECRUITING
Local Institution - 2201, Seville, Spain · NOT_YET_RECRUITING
Hospital Universitario Rio Hortega, Valladolid, Spain · RECRUITING
Local Institution - 2202, Zamora, Spain · NOT_YET_RECRUITING
Hospital Viamed Montecanal, Zaragoza, Spain · RECRUITING
Local Institution - 4702, Atakum, Samsun, Turkey (Türkiye) · NOT_YET_RECRUITING
Local Institution - 4706, Ankara, Turkey (Türkiye) · NOT_YET_RECRUITING
Local Institution - 4701, Eskişehir, Turkey (Türkiye) · NOT_YET_RECRUITING
Local Institution - 4704, Istanbul, Turkey (Türkiye) · NOT_YET_RECRUITING
Local Institution - 4705, Izmir, Turkey (Türkiye) · NOT_YET_RECRUITING
Local Institution - 4703, Izmir, Turkey (Türkiye) · NOT_YET_RECRUITING
Local Institution - 8007, Lviv, Lviv Oblast, Ukraine · NOT_YET_RECRUITING
Local Institution - 8002, Vinnytsia, Vinnytsia Oblast, Ukraine · NOT_YET_RECRUITING
Local Institution - 8001, Vinnytsia, Vinnytsia Oblast, Ukraine · NOT_YET_RECRUITING
Local Institution - 8003, Khmelnytskyi, Ukraine · NOT_YET_RECRUITING
Local Institution - 8006, Lviv, Ukraine · NOT_YET_RECRUITING
Local Institution - 8004, Smila, Ukraine · NOT_YET_RECRUITING
Local Institution - 8008, Ternopil, Ukraine · NOT_YET_RECRUITING
Local Institution - 8005, Uzhhorod, Ukraine · NOT_YET_RECRUITING
Local Institution - 2110, Ilford, Greater London, United Kingdom · WITHDRAWN
Local Institution - 2108, Swinton, Greater Manchester, United Kingdom · WITHDRAWN
Local Institution - 2105, Aberdeen, United Kingdom · WITHDRAWN
Local Institution - 2109, Chertsey, United Kingdom · WITHDRAWN
Local Institution - 2106, Leeds, United Kingdom · WITHDRAWN
Local Institution - 2104, Motherwell, United Kingdom · WITHDRAWN
Local Institution - 2111, Preston, United Kingdom · WITHDRAWN
Local Institution - 2107, Sheffield, SouthYorkshire, United Kingdom · WITHDRAWN
Local Institution - 2103, Swindon, United Kingdom · WITHDRAWN

Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2026-07-06.