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הניסוי הקליני NCT04641143 עבור הפרעה טורדנית-כפייתית הוא הושלם. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
חזרה לחיפוש
ביוהייבןEfficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder שלב III 456
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT04641143 נערך כדי לבדוק את טיפול עבור הפרעה טורדנית-כפייתית. זהו מחקר שלב III מסוג התערבותי שנמצא כעת במצב הושלם. המחקר התחיל ב-22 בדצמבר 2020 ותוכנן לכלול 456 משתתפים. המחקר נוהל על ידי ביוהייבן ותאריך הסיום היה 27 באוקטובר 2025. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-7 בינואר 2026.
סיכום קצר
The study's purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)
כותרת רשמית
A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
מצבים רפואיים
הפרעה טורדנית-כפייתיתמזהי מחקר נוספים
- BHV4157-302
מספר NCT
תחילת המחקר (בפועל)
2020-12-22
עדכון אחרון שפורסם
2026-01-07
סיום המחקר (מוערך)
2025-10-27
משתתפים (מתוכנן)
456
סוג המחקר
התערבותי
שלב
שלב III
סטטוס
הושלם
מילות מפתח
Obsessive-Compulsive Disorder
OCD
OCD
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
מרובע
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
משווה פעילTroriluzole Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten. | Troriluzole Troriluzole - 2 100mg capsules QD for the first two weeks. |
פלצבו להשוואהPlacebo Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten. | פלצבו Matching placebo - 2 140mg capsules QD from week two through week ten. |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS) | Improvement is measured by a lower total score | Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10 |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Frequency of SAEs and AEs leading to discontinuation | Percent difference between troriluzole vs placebo treatment emergent adverse events. | From Screening through study completion, up to 10 weeks |
Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS) | Change is measured as "mild" or "moderate" on the SDS | From baseline through study completion (up to 10 weeks) |
Improvement in global functioning responses assessed on the CGI-I scale. | Change is measured as "much improved" or "very much improved" on the CGII scale | From baseline through study completion (up to 10 weeks) |
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
- Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at Screening; The duration of the subject's illness must be ≥ 1 year
- An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response as defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the subject
- Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed
- Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD.
- Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourette's disorder, body dysmorphic disorder, hoarding disorder; or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results
- Previous treatment in a study with troriluzole
ביוהייבןאין נתוני קשר.
73 מיקומי המחקר ב-1 מדינות
Arizona
Metropolitan Neuro Behavioral Institute, Chandler, Arizona, 85284, United States
IMA Clinical Research, Phoenix, Arizona, 85012, United States
NoeisisPharma, LLC, Phoenix, Arizona, 85016, United States
California
CITrials (Clinical Innovations), Bellflower, California, 90706, United States
Axiom Research, LLC, Colton, California, 92324, United States
WR-PRI, LLC (Encino), Encino, California, 91316, United States
Behavioral Research Specialists, LLC, Glendale, California, 91206, United States
Pharmacology Research Institute, Los Alamitos, California, 90720, United States
Clarity Clinical Research, Los Angeles, California, 90064, United States
Excell Research, Inc, Oceanside, California, 92056, United States
NRC Research Institute, Orange, California, 92688, United States
Anderson Clinical Research, Redlands, California, 92374, United States
Lumos Clinical Research Center, LLC, San Jose, California, 95124, United States
California Neuroscience Research Medical Group, Inc, Sherman Oaks, California, 91403, United States
Stanford University, Stanford, California, 94305, United States
Collaborative Neuroscience Research, Torrance, California, 90502, United States
Connecticut
Yale University / Connecticut Mental Health Center, New Haven, Connecticut, 06519, United States
Comprehensive Psychiatric Care, Norwich, Connecticut, 06360, United States
Florida
Boca Raton Medical Institute, Boca Raton, Florida, 33431, United States
Advanced Clinical Research Network, Coral Gables, Florida, 33134, United States
Research in Miami Inc, Hialeah, Florida, 33013, United States
Accel Research Sites, Lakeland, Florida, 33803, United States
Innovative Clinical Research, Inc., Lauderhill, Florida, 33319, United States
Health Care Family Rehab & Research, Miami, Florida, 33015, United States
Central Miami Medical Institute, Miami, Florida, 33125, United States
FIRC, Miami, Florida, 33173, United States
Florida Research Center, Inc., Miami, Florida, 33174, United States
South Florida Research Phase I-IV , Inc., Miami Springs, Florida, 33166, United States
Behavioral Clinical Research, North Miami, Florida, 33161, United States
Medical Research Group of Central Florida, Orange City, Florida, 32763, United States
APG Research, LLC, Orlando, Florida, 32803, United States
Combined Research Orlando Phase I-IV, Orlando, Florida, 32807, United States
Omega Research Consultants, Orlando, Florida, 32808, United States
MedBio Trials, Pembroke Pines, Florida, 33026, United States
Stedman Clinical Trials, Tampa, Florida, 33613, United States
Neurobehaviorial Institute, Weston, Florida, 33326, United States
Conquest Research LLC, Winter Park, Florida, 32789, United States
Georgia
iResearch Atlanta, LLC, Decatur, Georgia, 30030, United States
iResearch Savannah, Savannah, Georgia, 31405, United States
Idaho
Northwest Clinical Trials, Boise, Idaho, 83704, United States
Illinois
Uptown Research Institute, Chicago, Illinois, 60640, United States
Revive Research Institute, Elgin, Illinois, 60123, United States
AMR-Baber Research, Inc, Naperville, Illinois, 60563, United States
Kansas
Collective Medical Research, Overland Park, Kansas, 66210, United States
Maryland
CBH Health, Gaithersburg, Maryland, 20877, United States
Pharmasite Research, Inc., Pikesville, Maryland, 21208, United States
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Boston Clinical Trials, Boston, Massachusetts, 02131, United States
ActivMed Practices and Research, Methuen, Massachusetts, 01844, United States
Sisu at RMG, Springfield, Massachusetts, 01103, United States
Michigan
Michigan Clinical Research Institute PC, Ann Arbor, Michigan, 48105, United States
Mississippi
Precise Research Centers, Flowood, Mississippi, 39232, United States
Missouri
Psychiatric Care and Research Center, O'Fallon, Missouri, 63368, United States
Nevada
Altea Research, Las Vegas, Nevada, 89102, United States
New Jersey
Hassman Research Institute, Berlin, New Jersey, 08009, United States
Bio Behavioral Health, Toms River, New Jersey, 08755, United States
New York
Integrative Clinical Trials, LLC, Brooklyn, New York, 11229, United States
Neurobehavioral Research, Inc, Cedarhurst, New York, 11516, United States
Bio Behavioral Institute, Great Neck, New York, 11021, United States
Bioscience Research, LLC, Mount Kisco, New York, 10549, United States
Manhattan Behavioral Medicine, PLLC, New York, New York, 10036, United States
Richmond Behavioral Associates, Staten Island, New York, 10312, United States
Ohio
Clinical Inquest Center, Ltd, Beavercreek, Ohio, 45431, United States
Oklahoma
Central States Research, LLC, Tulsa, Oklahoma, 74136, United States
Pennsylvania
Suburban Research Associates, Media, Pennsylvania, 19063, United States
Rhode Island
Comprehensive Psychiatric Care Providers, Providence, Rhode Island, 02906, United States
Texas
BioBehavioral Research of Austin, Austin, Texas, 78759, United States
Relaro Medical Trials, Dallas, Texas, 75243, United States
North Texas Clinical Trials, Fort Worth, Texas, 76104, United States
Baylor College of Medicine, Houston, Texas, 77030, United States
Texas Center for Drug Development, Inc., Houston, Texas, 77081, United States
Mt.Olympus Medical Research LLC, Missouri City, Texas, 77459, United States
Washington
Northwest Clinical Research Center, Bellevue, Washington, 98007, United States