Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
Sponsor
Biohaven Pharmaceuticals, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04708834
Collaborator
(none)
1,200
174
1
50.1
6.9
0.1
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive disorder (OCD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
Actual Study Start Date
:
Mar 30, 2021
Anticipated Primary Completion Date
:
Jun 1, 2024
Anticipated Study Completion Date
:
Jun 1, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Troriluzole (BHV-4157) 200 mg daily first 2 weeks, 280 daily for following 46 weeks |
Drug: Troriluzole (BHV-4157)
200 mg daily first 2 weeks, 280 daily for following 46 weeks
|
Outcome Measures
Primary Outcome Measures
- To evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with OCD who have had an inadequate response to SSRI, clomipramine, venlafaxine or desvenfaxine treatment [Change from Baseline to week 48]
Percent change in treatment emergent adverse events, and clinical significant abnormalities in ECG's and lab values after Baseline.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Eligible subjects are those subjects who complete study BHV4157-302 or BHV4157-303 and for whom the investigator believes open-label treatment offers an acceptable risk-benefit profile.
-
Determined by the investigator to be medically stable at the week 10 visit of BHV4157-302 or BHV4157-303, as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing.
-
It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study
Key Exclusion Criteria:
-
Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302 or BHV4157-303 study.
-
Acute suicidality or suicide attempt or self injurious behavior in the last 12 months.
-
Patients who may have received a non-biological investigational agent in any clinical trial within 30 days or a biological agent within 90 days prior to entry, other than what was received in BHV4157-302 or BHV4157-303;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Metropolitan Neuro Behavioral Institute | Chandler | Arizona | United States | 85226 |
| 2 | Alea Research | Phoenix | Arizona | United States | 85012 |
| 3 | NoeisisPharma, LLC | Phoenix | Arizona | United States | 85016 |
| 4 | Atria Clinical Research | Little Rock | Arkansas | United States | 72209 |
| 5 | Advanced Research Center, Inc. | Anaheim | California | United States | 92805 |
| 6 | CITrials (Clinical Innovations) | Bellflower | California | United States | 90706 |
| 7 | Southern California Research, LLC | Beverly Hills | California | United States | 90210 |
| 8 | Axiom Research, LLC | Colton | California | United States | 92324 |
| 9 | Global Clinical Trials | Costa Mesa | California | United States | 92627 |
| 10 | ProScience Research Group | Culver City | California | United States | 90230 |
| 11 | WR-PRI, LLC (Encino) | Encino | California | United States | 91316 |
| 12 | Behavioral Research Specialists, LLC | Glendale | California | United States | 91206 |
| 13 | Sun Valley Research Center, Inc. | Imperial | California | United States | 92251 |
| 14 | Om Research LLC | Lancaster | California | United States | 93534 |
| 15 | Synergy Research San Diego | Lemon Grove | California | United States | 91945 |
| 16 | Alliance for Research | Long Beach | California | United States | 90807 |
| 17 | Pharmacology Research Institute | Los Alamitos | California | United States | 90720 |
| 18 | CalNeuro Research Group | Los Angeles | California | United States | 90024 |
| 19 | Clarity Clinical Research | Los Angeles | California | United States | 90064 |
| 20 | Pharmacology Research Institute (WR-PRI, LLC) | Newport Beach | California | United States | 92660 |
| 21 | Pacific Research Partners | Oakland | California | United States | 94607 |
| 22 | North County Clinical Research | Oceanside | California | United States | 92054 |
| 23 | Excell Research, Inc | Oceanside | California | United States | 92056 |
| 24 | NRC Research Institute | Orange | California | United States | 92688 |
| 25 | Anderson Clinical Research | Redlands | California | United States | 92374 |
| 26 | CI Trials | Riverside | California | United States | 92506 |
| 27 | ACRC Studies | San Diego | California | United States | 92119 |
| 28 | Lumos Clinical Research Center, LLC | San Jose | California | United States | 95124 |
| 29 | National Research Institute | Santa Ana | California | United States | 92704 |
| 30 | California Neuroscience Research Medical Group, Inc | Sherman Oaks | California | United States | 91403 |
| 31 | Stanford University | Stanford | California | United States | 94305 |
| 32 | Collaborative Neuroscience Research | Torrance | California | United States | 90502 |
| 33 | Pacific Clinical Research Medical Group | Upland | California | United States | 91786 |
| 34 | Mountain View Clinical Research | Denver | Colorado | United States | 80209 |
| 35 | Institute of Living / Hartford Hospital | Hartford | Connecticut | United States | 06106 |
| 36 | Yale University | New Haven | Connecticut | United States | 06519 |
| 37 | Coastal Connecticut Research, LLC | New London | Connecticut | United States | 06320 |
| 38 | Comprehensive Psychiatric Care | Norwich | Connecticut | United States | 06360 |
| 39 | Topaz Clinical Research | Apopka | Florida | United States | 32703 |
| 40 | Boca Raton Medical Institute | Boca Raton | Florida | United States | 33431 |
| 41 | Advanced Clinical Research Network | Coral Gables | Florida | United States | 33134 |
| 42 | CNS Research of Coral Springs | Coral Springs | Florida | United States | 33067 |
| 43 | Gulfcoast Clinical Research Center | Fort Myers | Florida | United States | 33912 |
| 44 | University of Florida Department of Psychiatry | Gainesville | Florida | United States | 32606 |
| 45 | Qway Research, LLC | Hialeah | Florida | United States | 33010 |
| 46 | Research in Miami Inc | Hialeah | Florida | United States | 33013 |
| 47 | Health Care Family Rehab & Research | Hialeah | Florida | United States | 33015 |
| 48 | Galiz Research | Hialeah | Florida | United States | 33016 |
| 49 | Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | United States | 90024 |
| 50 | Accel Research Sites (formerly Meridien Research) | Lakeland | Florida | United States | 33803 |
| 51 | Innovative Clinical Research, Inc. | Lauderhill | Florida | United States | 33319 |
| 52 | Pharmaceutical Research Center, Inc. | Lutz | Florida | United States | 33548 |
| 53 | ClinCloud, LLC | Maitland | Florida | United States | 32751 |
| 54 | Meridien Research | Maitland | Florida | United States | 32751 |
| 55 | Pro-Care Research Center | Miami Gardens | Florida | United States | 33014 |
| 56 | South Florida Research Phase I-IV, Inc. | Miami Springs | Florida | United States | 33166 |
| 57 | Central Miami Medical Institute | Miami | Florida | United States | 33125 |
| 58 | Clintex Research | Miami | Florida | United States | 33135 |
| 59 | Sanchez Clinical Research Inc | Miami | Florida | United States | 33157 |
| 60 | Med-Care Research | Miami | Florida | United States | 33165 |
| 61 | FIRC | Miami | Florida | United States | 33173 |
| 62 | Florida Research Center, Inc. | Miami | Florida | United States | 33174 |
| 63 | Ezy Medical Research, Co. | Miami | Florida | United States | 33175 |
| 64 | Miami Dade Medical Research Institute | Miami | Florida | United States | 33176 |
| 65 | Advanced Research for Health Improvement | Naples | Florida | United States | 34102 |
| 66 | Bayside Clinical Research, LLC | New Port Richey | Florida | United States | 34655 |
| 67 | Bravo Health Care Center | North Bay Village | Florida | United States | 33141 |
| 68 | Harmony Clinical Research | North Miami Beach | Florida | United States | 33162 |
| 69 | Behavioral Clinical Research | North Miami | Florida | United States | 33161 |
| 70 | Medical Research Group of Central Florida | Orange City | Florida | United States | 32763 |
| 71 | APG Research, LLC | Orlando | Florida | United States | 32803 |
| 72 | Combined Research Orlando Phase I-IV | Orlando | Florida | United States | 32807 |
| 73 | Omega Research Consultants | Orlando | Florida | United States | 32808 |
| 74 | IMIC Inc | Palmetto Bay | Florida | United States | 33157 |
| 75 | MedBio Trials | Pembroke Pines | Florida | United States | 33026 |
| 76 | DMI Research | Pinellas Park | Florida | United States | 33782 |
| 77 | Lenus Research & Medical Group, LLC | Sweetwater | Florida | United States | 33172 |
| 78 | Stedman Clinical Trials | Tampa | Florida | United States | 33613 |
| 79 | Olympian Clinical Research | Tampa | Florida | United States | 33614 |
| 80 | Conquest Research LLC | Winter Park | Florida | United States | 32789 |
| 81 | NeuroTrials Research Inc | Atlanta | Georgia | United States | 30328 |
| 82 | iResearch Atlanta, LLC | Decatur | Georgia | United States | 30030 |
| 83 | iResearch Savannah | Savannah | Georgia | United States | 31405 |
| 84 | Renew Health Clinical Research, LLC | Snellville | Georgia | United States | 30078 |
| 85 | Northwest Clinical Trials | Boise | Idaho | United States | 83704 |
| 86 | Uptown Research Institute | Chicago | Illinois | United States | 60640 |
| 87 | University of Chicago Department of Psychiatry & Behavioral Neuroscience | Chicago | Illinois | United States | 91786 |
| 88 | Revive Research Institute | Elgin | Illinois | United States | 60123 |
| 89 | Capstone Clinical Research | Libertyville | Illinois | United States | 60048 |
| 90 | AMR-Baber Research, Inc | Naperville | Illinois | United States | 60563 |
| 91 | Collective Medical Research | Prairie Village | Kansas | United States | 66208 |
| 92 | Northern Light Acadia Hospital | Bangor | Maine | United States | 04401 |
| 93 | CBH Health | Gaithersburg | Maryland | United States | 20877 |
| 94 | Pharmasite Research, Inc. | Pikesville | Maryland | United States | 21208 |
| 95 | Continental Clinical Solutions, LLC | Towson | Maryland | United States | 21204 |
| 96 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 97 | Boston Clinical Trials | Boston | Massachusetts | United States | 02131 |
| 98 | ActivMed Practices and Research | Methuen | Massachusetts | United States | 01844 |
| 99 | Sisu at RMG | Springfield | Massachusetts | United States | 01103 |
| 100 | Adams Clinical | Watertown | Massachusetts | United States | 02472 |
| 101 | Michigan Clinical Research Institute PC | Ann Arbor | Michigan | United States | 48105 |
| 102 | Precise Research Centers | Flowood | Mississippi | United States | 39232 |
| 103 | Psychiatric Care and Research Center | O'Fallon | Missouri | United States | 63368 |
| 104 | PsychCare Consultants Research | Saint Louis | Missouri | United States | 63128 |
| 105 | Boeson Research | Missoula | Montana | United States | 59804 |
| 106 | Altea Research | Las Vegas | Nevada | United States | 89102 |
| 107 | Hassman Research Institute | Berlin | New Jersey | United States | 08009 |
| 108 | Center for Emotional Fitness | Cherry Hill | New Jersey | United States | 08002 |
| 109 | Bio Behavioral Health | Toms River | New Jersey | United States | 08755 |
| 110 | Integrative Clinical Trials, LLC | Brooklyn | New York | United States | 11229 |
| 111 | SPRI Clinical Trials, LLC | Brooklyn | New York | United States | 11235 |
| 112 | Neurobehavioral Research, Inc | Cedarhurst | New York | United States | 11516 |
| 113 | Bio Behavioral Institute | Great Neck | New York | United States | 11021 |
| 114 | Bioscience Research, LLC | Mount Kisco | New York | United States | 10549 |
| 115 | Hapworth Research | New York | New York | United States | 10019 |
| 116 | New York State Psychiatric Institute | New York | New York | United States | 10032 |
| 117 | Manhattan Behavioral Medicine, PLLC | New York | New York | United States | 10036 |
| 118 | Finger Lakes Clinical Research | Rochester | New York | United States | 14618 |
| 119 | Richmond Behavioral Associates | Staten Island | New York | United States | 10312 |
| 120 | Carolina Institute for Clinical Research | Fayetteville | North Carolina | United States | 28303 |
| 121 | Clinical Inquest Center, Ltd | Beavercreek | Ohio | United States | 45431 |
| 122 | NeuroScience Research Center, LLC. | Canton | Ohio | United States | 44718 |
| 123 | CTI Clinical Research Center | Cincinnati | Ohio | United States | 45212 |
| 124 | Midwest Clinical Research Center | Dayton | Ohio | United States | 45417 |
| 125 | IPS Research | Oklahoma City | Oklahoma | United States | 73106 |
| 126 | Central States Research, LLC | Tulsa | Oklahoma | United States | 74136 |
| 127 | Lehigh Center for Clinical Research | Allentown | Pennsylvania | United States | 18104 |
| 128 | Suburban Research Associates | Media | Pennsylvania | United States | 19063 |
| 129 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 130 | Coastal Carolina Research Center | Mount Pleasant | South Carolina | United States | 29464 |
| 131 | BioBehavioral Research of Austin | Austin | Texas | United States | 78759 |
| 132 | Inquest Clinical Research | Baytown | Texas | United States | 77521 |
| 133 | DiscoveResearch, Inc. (DRI) | Bryan | Texas | United States | 77802 |
| 134 | FutureSearch Trials of Dallas, LP | Dallas | Texas | United States | 75231 |
| 135 | Relaro Medical Trials | Dallas | Texas | United States | 75243 |
| 136 | InSite Clinical Research | DeSoto | Texas | United States | 75115 |
| 137 | North Texas Clinical Trials | Fort Worth | Texas | United States | 76104 |
| 138 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 139 | Clinical Trial Network | Houston | Texas | United States | 77074 |
| 140 | Texas Center for Drug Development, Inc. | Houston | Texas | United States | 77081 |
| 141 | SMS Clinical Research | Mesquite | Texas | United States | 75149 |
| 142 | Mt.Olympus Medical Research LLC | Missouri City | Texas | United States | 77459 |
| 143 | AIM Trials | Plano | Texas | United States | 75093 |
| 144 | Clinical Trials of Texas, Inc. | San Antonio | Texas | United States | 78229 |
| 145 | Grayline Research Center | Wichita Falls | Texas | United States | 76309 |
| 146 | Woodstock Research Center | Woodstock | Vermont | United States | 05091 |
| 147 | Northwest Clinical Research Center | Bellevue | Washington | United States | 98007 |
| 148 | University of Calgary | Calgary | Alberta | Canada | T2N 4Z6 |
| 149 | Chatham-Kent Clinical Trials Research Centre | Chatham | Ontario | Canada | N7L 1C1 |
| 150 | McMaster University, Hamilton Health Sciences | Hamilton | Ontario | Canada | L8S 1B7 |
| 151 | Queen's University | Kingston | Ontario | Canada | K7L 5G2 |
| 152 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 153 | START Clinic for Mood and Anxiety Disorders | Toronto | Ontario | Canada | M4W 2N4 |
| 154 | University of Toronto / Centre for Addiction and Mental Health (CAMH) | Toronto | Ontario | Canada | M6J 1H4 |
| 155 | Institute of Neuroscience, University of Firenze | Florence | Italy | 50121 | |
| 156 | ASST FBF SACCO - Ospedale Universitario Luigi Sacco | Milan | Italy | 20157 | |
| 157 | University School of Medicine of Napoli Federico II | Naples | Italy | 80131 | |
| 158 | University of Pisa | Pisa | Italy | 56126 | |
| 159 | University of Turin - university hospital san luigi gonzaga | Turin | Italy | 10043 | |
| 160 | Amsterdam UMC, locatie AMC | Amsterdam | Netherlands | 1100 | |
| 161 | Leiden University Medical Center (LUMC) | Leiden | Netherlands | 2333 | |
| 162 | Hospital Universitario de Bellvitge | Barcelona | Spain | 08907 | |
| 163 | Hospital Universitario Ramón y Cajal | Madrid | Spain | 28034 | |
| 164 | Hospital Clínico San Carlos | Madrid | Spain | 28040 | |
| 165 | Centro de Salud Mental La Corredoria | Oviedo | Spain | 33011 | |
| 166 | Centro de Salud San Juan | Salamanca | Spain | 37005 | |
| 167 | Hospital Álvaro Cunqueiro | Vigo | Spain | 36312 | |
| 168 | MAC Clinical Research-Lancashire | Blackpool | United Kingdom | FY2 0JH | |
| 169 | Surrey and Borders Partnership NHS Foundation Trust | Chertsey | United Kingdom | KT16 0AE | |
| 170 | MAC Clinical Research -- Merseyside | Liverpool | United Kingdom | L34 1BH | |
| 171 | South West London and St George's Mental Health NHS Trust Springfield University Hospital | London | United Kingdom | SW17 7DJ | |
| 172 | MAC Clinical Research-Greater Manchester | Manchester | United Kingdom | M13 9NQ | |
| 173 | Greater Manchester Mental Health NHS Foundation Trust | Manchester | United Kingdom | M25 3BL | |
| 174 | MAC Clinical Research-- South Yorkshire | Tankersley | United Kingdom | S75 3DL |
Sponsors and Collaborators
- Biohaven Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT04708834
Other Study ID Numbers:
- BHV4157-209
First Posted:
Jan 14, 2021
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Biohaven Pharmaceuticals, Inc.
Additional relevant MeSH terms: