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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Troriluzole | Active Comparator | Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten. |
|
| Placebo | Placebo Comparator | Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Troriluzole | Drug | Troriluzole - 2 100mg capsules QD for the first two weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metropolitan Neuro Behavioral Institute | Chandler | Arizona | 85284 | United States | ||
| IMA Clinical Research |
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| Placebo |
| Drug |
Matching placebo - 2 140mg capsules QD from week two through week ten. |
|
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) |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| NoeisisPharma, LLC | Phoenix | Arizona | 85016 | United States |
| 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 |
| Yale University / Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States |
| Comprehensive Psychiatric Care | Norwich | Connecticut | 06360 | United States |
| 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 |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| iResearch Savannah | Savannah | Georgia | 31405 | United States |
| Northwest Clinical Trials | Boise | Idaho | 83704 | United States |
| 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 |
| Collective Medical Research | Overland Park | Kansas | 66210 | United States |
| CBH Health | Gaithersburg | Maryland | 20877 | United States |
| Pharmasite Research, Inc. | Pikesville | Maryland | 21208 | United States |
| 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 Clinical Research Institute PC | Ann Arbor | Michigan | 48105 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | United States |
| Altea Research | Las Vegas | Nevada | 89102 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| 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 |
| Clinical Inquest Center, Ltd | Beavercreek | Ohio | 45431 | United States |
| Central States Research, LLC | Tulsa | Oklahoma | 74136 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Comprehensive Psychiatric Care Providers | Providence | Rhode Island | 02906 | United States |
| 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 |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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