Langsigtet sikkerhedsundersøgelse af adjunktiv troriluzol hos personer med obsessiv-kompulsiv lidelse
23. februar 2026 opdateret af: Biohaven Pharmaceuticals, Inc.
En multicenter, langsigtet åben-label sikkerhedsundersøgelse af adjunktiv troriluzol hos personer med obsessiv-kompulsiv lidelse
Formålet med undersøgelsen er at evaluere den langsigtede sikkerhed og tolerabilitet af troriluzol som supplerende terapi hos personer med obsessiv-kompulsiv lidelse (OCD).
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
772
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- University Of Calgary
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Ontario
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Chatham, Ontario, Canada, N7L 1C1
- Chatham-Kent Clinical Trials Research Centre
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Hamilton, Ontario, Canada, L8S 1B7
- McMaster University, Hamilton Health Sciences
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Kingston, Ontario, Canada, K7L 5G2
- Queen's University
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M4W 2N4
- START Clinic for Mood and Anxiety Disorders
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Toronto, Ontario, Canada, M6J 1H4
- University of Toronto / Centre for Addiction and Mental Health (CAMH)
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Blackpool, Det Forenede Kongerige, FY2 0JH
- MAC Clinical Research-Lancashire
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Chertsey, Det Forenede Kongerige, KT16 0AE
- Surrey and Borders Partnership NHS Foundation Trust
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Liverpool, Det Forenede Kongerige, L34 1BH
- MAC Clinical Research -- Merseyside
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London, Det Forenede Kongerige, SW17 7DJ
- South West London and St George's Mental Health NHS Trust Springfield University Hospital
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Manchester, Det Forenede Kongerige, M13 9NQ
- MAC Clinical Research-Greater Manchester
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Manchester, Det Forenede Kongerige, M25 3BL
- Greater Manchester Mental Health NHS Foundation Trust
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Milton Keynes, Det Forenede Kongerige, MK15 0DU
- Bioluminux Ltd
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Tankersley, Det Forenede Kongerige, S75 3DL
- MAC Clinical Research-- South Yorkshire
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Arizona
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Chandler, Arizona, Forenede Stater, 85226
- Metropolitan Neuro Behavioral Institute
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Phoenix, Arizona, Forenede Stater, 85012
- Alea Research
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Phoenix, Arizona, Forenede Stater, 85016
- NoeisisPharma, LLC
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72209
- Atria Clinical Research
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California
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Anaheim, California, Forenede Stater, 92805
- Advanced Research Center, Inc.
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Bellflower, California, Forenede Stater, 90706
- CITrials (Clinical Innovations)
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Beverly Hills, California, Forenede Stater, 90210
- Southern California Research, LLC
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Colton, California, Forenede Stater, 92324
- Axiom Research, LLC
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Costa Mesa, California, Forenede Stater, 92627
- Global Clinical Trials
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Culver City, California, Forenede Stater, 90230
- Proscience Research Group
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Encino, California, Forenede Stater, 91316
- WR-PRI, LLC (Encino)
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Glendale, California, Forenede Stater, 91206
- Behavioral Research Specialists, LLC
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Imperial, California, Forenede Stater, 92251
- Sun Valley Research Center, Inc.
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Lancaster, California, Forenede Stater, 93534
- Om Research LLC
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Lemon Grove, California, Forenede Stater, 91945
- Synergy Research San Diego
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Long Beach, California, Forenede Stater, 90807
- Alliance for Research
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Los Alamitos, California, Forenede Stater, 90720
- Pharmacology Research Institute
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Los Angeles, California, Forenede Stater, 90024
- CalNeuro Research Group
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Los Angeles, California, Forenede Stater, 90064
- Clarity Clinical Research
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Newport Beach, California, Forenede Stater, 92660
- Pharmacology Research Institute (WR-PRI, LLC)
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Oakland, California, Forenede Stater, 94607
- Pacific Research Partners
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Oceanside, California, Forenede Stater, 92054
- North County Clinical Research
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Oceanside, California, Forenede Stater, 92056
- Excell Research, Inc
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Orange, California, Forenede Stater, 92688
- NRC Research Institute
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Redlands, California, Forenede Stater, 92374
- Anderson Clinical Research
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Riverside, California, Forenede Stater, 92506
- CI Trials
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San Diego, California, Forenede Stater, 92119
- ACRC Studies
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San Jose, California, Forenede Stater, 95124
- Lumos Clinical Research Center, LLC
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Santa Ana, California, Forenede Stater, 92704
- National Research Institute
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Sherman Oaks, California, Forenede Stater, 91403
- California Neuroscience Research Medical Group, Inc
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Stanford, California, Forenede Stater, 94305
- Stanford University
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Torrance, California, Forenede Stater, 90502
- Collaborative Neuroscience Research
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Upland, California, Forenede Stater, 91786
- Pacific Clinical Research Medical Group
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Colorado
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Denver, Colorado, Forenede Stater, 80209
- Mountain View Clinical Research
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06106
- Institute of Living / Hartford Hospital
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New Haven, Connecticut, Forenede Stater, 06519
- Yale University
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New London, Connecticut, Forenede Stater, 06320
- Coastal Connecticut Research, LLC
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Norwich, Connecticut, Forenede Stater, 06360
- Comprehensive Psychiatric Care
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Florida
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Apopka, Florida, Forenede Stater, 32703
- Topaz Clinical Research
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Boca Raton, Florida, Forenede Stater, 33431
- Boca Raton Medical Institute
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Coral Gables, Florida, Forenede Stater, 33134
- Advanced Clinical Research Network
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Coral Springs, Florida, Forenede Stater, 33067
- CNS Research of Coral Springs
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Fort Myers, Florida, Forenede Stater, 33912
- Gulfcoast Clinical Research Center
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Gainesville, Florida, Forenede Stater, 32606
- University of Florida Department of Psychiatry
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Hialeah, Florida, Forenede Stater, 33010
- Qway Research, LLC
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Hialeah, Florida, Forenede Stater, 33016
- Galiz Research
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Hialeah, Florida, Forenede Stater, 33013
- Research in Miami Inc
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Hialeah, Florida, Forenede Stater, 33015
- Health Care Family Rehab & Research
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Jacksonville, Florida, Forenede Stater, 90024
- Clinical Neuroscience Solutions, Inc
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Lakeland, Florida, Forenede Stater, 33803
- Accel Research Sites (formerly Meridien Research)
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Lauderhill, Florida, Forenede Stater, 33319
- Innovative Clinical Research, Inc.
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Lutz, Florida, Forenede Stater, 33548
- Pharmaceutical Research Center, Inc.
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Maitland, Florida, Forenede Stater, 32751
- Meridien Research
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Maitland, Florida, Forenede Stater, 32751
- ClinCloud, LLC
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Miami, Florida, Forenede Stater, 33176
- Miami Dade Medical Research Institute
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Miami, Florida, Forenede Stater, 33165
- Med-Care Research
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Miami, Florida, Forenede Stater, 33174
- Florida Research Center, Inc.
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Miami, Florida, Forenede Stater, 33157
- Sanchez Clinical Research Inc
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Miami, Florida, Forenede Stater, 33125
- Central Miami Medical Institute
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Miami, Florida, Forenede Stater, 33135
- Clintex Research
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Miami, Florida, Forenede Stater, 33173
- FIRC
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Miami, Florida, Forenede Stater, 33175
- Ezy Medical Research, Co.
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Miami Gardens, Florida, Forenede Stater, 33014
- Pro-Care Research Center
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Miami Springs, Florida, Forenede Stater, 33166
- South Florida Research Phase I-IV, Inc.
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Naples, Florida, Forenede Stater, 34102
- Advanced Research for Health Improvement
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New Port Richey, Florida, Forenede Stater, 34655
- Bayside Clinical Research, LLC
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North Bay Village, Florida, Forenede Stater, 33141
- Bravo Health Care Center
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North Miami, Florida, Forenede Stater, 33161
- Behavioral Clinical Research
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North Miami Beach, Florida, Forenede Stater, 33162
- Harmony Clinical Research
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Orange City, Florida, Forenede Stater, 32763
- Medical Research Group of Central Florida
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Orlando, Florida, Forenede Stater, 32803
- Apg Research, Llc
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Orlando, Florida, Forenede Stater, 32808
- Omega Research Consultants
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Orlando, Florida, Forenede Stater, 32807
- Combined Research Orlando Phase I-IV
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Palmetto Bay, Florida, Forenede Stater, 33157
- IMIC Inc
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Pembroke Pines, Florida, Forenede Stater, 33026
- MedBio Trials
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Pinellas Park, Florida, Forenede Stater, 33782
- DMI Research
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Sweetwater, Florida, Forenede Stater, 33172
- LENUS Research & Medical Group, LLC
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Tampa, Florida, Forenede Stater, 33613
- Stedman Clinical Trials
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Tampa, Florida, Forenede Stater, 33614
- Olympian Clinical Research
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Winter Park, Florida, Forenede Stater, 32789
- Conquest Research LLC
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Georgia
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Atlanta, Georgia, Forenede Stater, 30328
- Neurotrials Research Inc
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Decatur, Georgia, Forenede Stater, 30030
- iResearch Atlanta, LLC
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Savannah, Georgia, Forenede Stater, 31405
- iResearch Savannah
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Snellville, Georgia, Forenede Stater, 30078
- Renew Health Clinical Research, LLC
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Idaho
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Boise, Idaho, Forenede Stater, 83704
- Northwest Clinical Trials
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Illinois
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Chicago, Illinois, Forenede Stater, 60640
- Uptown Research Institute
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Chicago, Illinois, Forenede Stater, 91786
- University of Chicago Department of Psychiatry & Behavioral Neuroscience
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Elgin, Illinois, Forenede Stater, 60123
- Revive Research Institute
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Libertyville, Illinois, Forenede Stater, 60048
- Capstone Clinical Research
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Naperville, Illinois, Forenede Stater, 60563
- AMR-Baber Research, Inc
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Kansas
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Prairie Village, Kansas, Forenede Stater, 66208
- Collective Medical Research
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Maine
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Bangor, Maine, Forenede Stater, 04401
- Northern Light Acadia Hospital
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Maryland
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Gaithersburg, Maryland, Forenede Stater, 20877
- CBH Health
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Pikesville, Maryland, Forenede Stater, 21208
- Pharmasite Research, Inc.
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Towson, Maryland, Forenede Stater, 21204
- Continental Clinical Solutions, LLC
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forenede Stater, 02131
- Boston Clinical Trials
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Methuen, Massachusetts, Forenede Stater, 01844
- ActivMed Practices and Research
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Springfield, Massachusetts, Forenede Stater, 01103
- Sisu at RMG
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Watertown, Massachusetts, Forenede Stater, 02472
- Adams Clinical
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48105
- Michigan Clinical Research Institute PC
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Mississippi
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Flowood, Mississippi, Forenede Stater, 39232
- Precise Research Centers
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Missouri
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O'Fallon, Missouri, Forenede Stater, 63368
- Psychiatric Care and Research Center
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St Louis, Missouri, Forenede Stater, 63128
- PsychCare Consultants Research
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Montana
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Missoula, Montana, Forenede Stater, 59804
- Boeson Research
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
- Altea Research
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New Jersey
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Berlin, New Jersey, Forenede Stater, 08009
- Hassman Research Institute
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Cherry Hill, New Jersey, Forenede Stater, 08002
- Center for Emotional Fitness
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Toms River, New Jersey, Forenede Stater, 08755
- Bio Behavioral Health
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New York
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Brooklyn, New York, Forenede Stater, 11229
- Integrative Clinical Trials, LLC
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Brooklyn, New York, Forenede Stater, 11235
- SPRI Clinical Trials, LLC
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Cedarhurst, New York, Forenede Stater, 11516
- Neurobehavioral Research, Inc
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Great Neck, New York, Forenede Stater, 11021
- Bio Behavioral Institute
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Mount Kisco, New York, Forenede Stater, 10549
- Bioscience Research, LLC
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New York, New York, Forenede Stater, 10032
- New York State Psychiatric Institute
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New York, New York, Forenede Stater, 10036
- Manhattan Behavioral Medicine, PLLC
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New York, New York, Forenede Stater, 10019
- Hapworth Research
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Rochester, New York, Forenede Stater, 14618
- Finger Lakes Clinical Research
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Staten Island, New York, Forenede Stater, 10312
- Richmond Behavioral Associates
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North Carolina
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Fayetteville, North Carolina, Forenede Stater, 28303
- Carolina Institute for Clinical Research
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Ohio
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Beavercreek, Ohio, Forenede Stater, 45431
- Clinical Inquest Center, LTD
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Canton, Ohio, Forenede Stater, 44718
- NeuroScience Research Center, LLC.
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Cincinnati, Ohio, Forenede Stater, 45212
- CTI Clinical Research Center
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Dayton, Ohio, Forenede Stater, 45417
- Midwest Clinical Research Center
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73106
- IPS Research
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Tulsa, Oklahoma, Forenede Stater, 74136
- Central States Research, LLC
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18104
- Lehigh Center For Clinical Research
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Media, Pennsylvania, Forenede Stater, 19063
- Suburban Research Associates
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
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South Carolina
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Mt. Pleasant, South Carolina, Forenede Stater, 29464
- Coastal Carolina Research Center
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Texas
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Austin, Texas, Forenede Stater, 78759
- BioBehavioral Research of Austin
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Baytown, Texas, Forenede Stater, 77521
- Inquest Clinical Research
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Bryan, Texas, Forenede Stater, 77802
- DiscoveResearch, Inc. (DRI)
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Dallas, Texas, Forenede Stater, 75231
- FutureSearch Trials of Dallas, LP
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Dallas, Texas, Forenede Stater, 75243
- Relaro Medical Trials
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DeSoto, Texas, Forenede Stater, 75115
- Insite clinical research
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Fort Worth, Texas, Forenede Stater, 76104
- North Texas Clinical Trials
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine
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Houston, Texas, Forenede Stater, 77081
- Texas Center for Drug Development, Inc.
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Houston, Texas, Forenede Stater, 77074
- Clinical Trial Network
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Mesquite, Texas, Forenede Stater, 75149
- SMS Clinical Research
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Missouri City, Texas, Forenede Stater, 77459
- Mt.Olympus Medical Research LLC
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Plano, Texas, Forenede Stater, 75093
- AIM Trials
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San Antonio, Texas, Forenede Stater, 78229
- Clinical Trials of Texas, Inc.
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Wichita Falls, Texas, Forenede Stater, 76309
- Grayline Research Center
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Vermont
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Woodstock, Vermont, Forenede Stater, 05091
- Woodstock Research Center
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Washington
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Bellevue, Washington, Forenede Stater, 98007
- Northwest Clinical Research Center
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Amsterdam, Holland, 1100
- Amsterdam UMC, Locatie AMC
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Leiden, Holland, 2333
- Leiden University Medical Center (LUMC)
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Florence, Italien, 50121
- Institute of Neuroscience, University of Firenze
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Milan, Italien, 20157
- ASST FBF SACCO - Ospedale Universitario Luigi Sacco
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Naples, Italien, 80131
- University School of Medicine of Napoli Federico II
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Pisa, Italien, 56126
- University of Pisa
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Turin, Italien, 10043
- University of Turin - university hospital san luigi gonzaga
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Barcelona, Spanien, 08907
- Hospital Universitario de Bellvitge
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Madrid, Spanien, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Spanien, 28040
- Hospital Clinico San Carlos
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Oviedo, Spanien, 33011
- Centro de Salud Mental La Corredoria
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Salamanca, Spanien, 37005
- Centro de Salud San Juan
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Vigo, Spanien, 36312
- Hospital Alvaro Cunqueiro
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 61 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Nøgleinklusionskriterier:
- Kvalificerede forsøgspersoner er de forsøgspersoner, der gennemfører undersøgelsen BHV4157-302 eller BHV4157-303, og for hvem investigatoren mener, at åben behandling giver en acceptabel risiko-benefit-profil.
- Fastslået af investigator at være medicinsk stabil ved uge 10 besøg af BHV4157-302 eller BHV4157-303, vurderet ud fra sygehistorie, fysisk undersøgelse, laboratorietestresultater og elektrokardiogramtestning.
- Det kræves, at alle kvinder i den fødedygtige alder (WOCBP), som er seksuelt aktive, accepterer at bruge to præventionsmetoder i hele undersøgelsens varighed
Nøgleekskluderingskriterier:
- Forsøgspersoner, der ikke gennemførte 10 ugers behandling med succes i BHV4157-302- eller BHV4157-303-undersøgelsen.
- Akut suicidalitet eller selvmordsforsøg eller selvskadende adfærd inden for de sidste 12 måneder.
- Patienter, der kan have modtaget et ikke-biologisk forsøgsmiddel i et hvilket som helst klinisk forsøg inden for 30 dage eller et biologisk middel inden for 90 dage før indrejse, bortset fra hvad der blev modtaget i BHV4157-302 eller BHV4157-303;
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Troriluzol (BHV-4157)
200 mg dagligt de første 2 uger, 280 mg dagligt efter de første 2 uger
|
200 mg dagligt de første 2 uger, 280 mg dagligt efter de første 2 uger
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
For at evaluere den langsigtede sikkerhed og tolerabilitet af troriluzol som supplerende terapi hos personer med OCD, som har haft et utilstrækkeligt respons på SSRI-, clomipramin-, venlafaxin- eller desvenfaxinbehandling
Tidsramme: Skift fra baseline til uge 240
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Procentvis ændring i behandlingsfremkomne bivirkninger og klinisk signifikante abnormiteter i EKG'er og laboratorieværdier efter baseline.
|
Skift fra baseline til uge 240
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. marts 2021
Primær færdiggørelse (Faktiske)
13. februar 2026
Studieafslutning (Faktiske)
13. februar 2026
Datoer for studieregistrering
Først indsendt
11. januar 2021
Først indsendt, der opfyldte QC-kriterier
12. januar 2021
Først opslået (Faktiske)
14. januar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. februar 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. februar 2026
Sidst verificeret
1. februar 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BHV4157-209
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .