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Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Troriluzole
Placebo
Sponsored by
Biohaven Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, OCD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. 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
  3. 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

Exclusion Criteria:

  1. 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.
  2. 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
  3. Previous treatment in a study with troriluzole

Sites / Locations

  • Metropolitan Neuro Behavioral InstituteRecruiting
  • NoeisisPharma, LLCRecruiting
  • Atria Clinical Research
  • Advanced Research Center, Inc.Recruiting
  • CITrials (Clinical Innovations)Recruiting
  • Axiom Research, LLCRecruiting
  • Global Clinical Trials
  • WR-PRI, LLC (Encino)Recruiting
  • Behavioral Research Specialists, LLCRecruiting
  • Synergy Research San Diego
  • Pharmacology Research InstituteRecruiting
  • Clarity Clinical ResearchRecruiting
  • Pharmacology Research Institute (WR-PRI, LLC)Recruiting
  • Pacific Research Partners
  • Excell Research, IncRecruiting
  • NRC Research InstituteRecruiting
  • Anderson Clinical ResearchRecruiting
  • ACRC Studies
  • Stanford UniversityRecruiting
  • Collaborative Neuroscience ResearchRecruiting
  • Yale University / Connecticut Mental Health CenterRecruiting
  • Coastal Connecticut Research, LLC
  • Boca Raton Medical InstituteRecruiting
  • Advanced Clinical Research NetworkRecruiting
  • Research in Miami IncRecruiting
  • Galiz ResearchRecruiting
  • Accel Research SitesRecruiting
  • Innovative Clinical Research, Inc.
  • ClinCloud, LLCRecruiting
  • Pro-Care Research Center
  • South Florida Research Phase I-IV , Inc.Recruiting
  • Health Care Family Rehab & ResearchRecruiting
  • Central Miami Medical InstituteRecruiting
  • Sanchez Clinical Research IncRecruiting
  • FIRCRecruiting
  • Florida Research Center, Inc.Recruiting
  • Bayside Clinical Research, LLCRecruiting
  • Behavioral Clinical ResearchRecruiting
  • Medical Research Group of Central FloridaRecruiting
  • APG Research, LLCRecruiting
  • Combined Research Orlando Phase I-IVRecruiting
  • Omega Research ConsultantsRecruiting
  • IMIC Inc
  • MedBio Trials
  • Lenus Research & Medical Group, LLCRecruiting
  • Stedman Clinical TrialsRecruiting
  • Conquest Research LLCRecruiting
  • NeuroTrials Research Inc
  • iResearch SavannahRecruiting
  • Northwest Clinical TrialsRecruiting
  • Uptown Research InstituteRecruiting
  • Revive Research InstituteRecruiting
  • Capstone Clinical Research
  • CBH HealthRecruiting
  • Pharmasite Research, Inc.Recruiting
  • Massachusetts General HospitalRecruiting
  • ActivMed Practices and ResearchRecruiting
  • Sisu at RMGRecruiting
  • Michigan Clinical Research Institute PCRecruiting
  • Precise Research CentersRecruiting
  • PsychCare Consultants ResearchRecruiting
  • Altea ResearchRecruiting
  • Hassman Research InstituteRecruiting
  • Bio Behavioral Health
  • Integrative Clinical Trials, LLCRecruiting
  • Neurobehavioral Research, IncRecruiting
  • Bio Behavioral Institute
  • Bioscience Research, LLCRecruiting
  • Hapworth ResearchRecruiting
  • Richmond Behavioral AssociatesRecruiting
  • Clinical Inquest Center, LtdRecruiting
  • NeuroScience Research Center, LLC.Recruiting
  • Midwest Clinical Research CenterRecruiting
  • Central States Research, LLCRecruiting
  • Comprehensive Psychiatric Care ProvidersRecruiting
  • BioBehavioral Research of AustinRecruiting
  • DiscoveResearch, Inc. (DRI)
  • Relaro Medical TrialsRecruiting
  • North Texas Clinical TrialsRecruiting
  • Baylor College of MedicineRecruiting
  • Texas Center for Drug Development, Inc.Recruiting
  • SMS Clinical ResearchRecruiting
  • Mt.Olympus Medical Research LLCRecruiting
  • Grayline Research CenterRecruiting
  • Northwest Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Troriluzole

Placebo

Arm Description

Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten.

Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten.

Outcomes

Primary Outcome Measures

The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Improvement is measured by a lower total score

Secondary Outcome Measures

Frequency of SAEs and AEs leading to discontinuation
Percent difference between troriluzole vs placebo treatment emergent adverse events.
Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS)
Change is measured as "mild" or "moderate" on the SDS
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

Full Information

First Posted
November 12, 2020
Last Updated
January 12, 2023
Sponsor
Biohaven Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04641143
Brief Title
Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biohaven Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder, OCD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Troriluzole
Arm Type
Active Comparator
Arm Description
Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten.
Intervention Type
Drug
Intervention Name(s)
Troriluzole
Intervention Description
Troriluzole - 2 100mg capsules QD for the first two weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo - 2 140mg capsules QD from week two through week ten.
Primary Outcome Measure Information:
Title
The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Description
Improvement is measured by a lower total score
Time Frame
Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10
Secondary Outcome Measure Information:
Title
Frequency of SAEs and AEs leading to discontinuation
Description
Percent difference between troriluzole vs placebo treatment emergent adverse events.
Time Frame
From Screening through study completion, up to 10 weeks
Title
Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS)
Description
Change is measured as "mild" or "moderate" on the SDS
Time Frame
From baseline through study completion (up to 10 weeks)
Title
Improvement in global functioning responses assessed on the CGI-I scale.
Description
Change is measured as "much improved" or "very much improved" on the CGII scale
Time Frame
From baseline through study completion (up to 10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chief Medical Officer
Phone
203-404-0410
Email
clinicaltrials@biohavenpharma.com
Facility Information:
Facility Name
Metropolitan Neuro Behavioral Institute
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Wallace
Phone
800-774-1534
Email
r.wallace@prgresearch.com
Facility Name
NoeisisPharma, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Ann Kelley
Phone
602-795-1834
Email
lkelley@noesispharma.com
Facility Name
Atria Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Individual Site Status
Withdrawn
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Austina Cho
Phone
714-999-6688
Email
dr.cho@arctrials.com
Facility Name
CITrials (Clinical Innovations)
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maribel Balderas
Phone
562-748-4999
Email
maribel.balderas@citrials.com
Facility Name
Axiom Research, LLC
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanya Powell
Phone
909-824-2325
Email
tanyapowell@axiomresearch.com
Facility Name
Global Clinical Trials
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Individual Site Status
Withdrawn
Facility Name
WR-PRI, LLC (Encino)
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Vuong
Phone
818-705-7451
Email
jvuong@priresearch.com
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harry Chung
Phone
888-255-5798
Email
harry@brstrials.com
Facility Name
Synergy Research San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Individual Site Status
Withdrawn
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mellissa Henry
Phone
714-827-3668
Email
mhenry@priresearch.com
Facility Name
Clarity Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raul Gonzalez
Phone
310-508-3191
Email
Raul@thecrcacademy.com
Facility Name
Pharmacology Research Institute (WR-PRI, LLC)
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
My-Linh Tong
Phone
949-752-7910
Email
mtong@priresearch.com
Facility Name
Pacific Research Partners
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Individual Site Status
Withdrawn
Facility Name
Excell Research, Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madeleine Gathman
Phone
760-758-2222
Email
mgathman@excellresearch.com
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92688
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniella VanBlitter
Phone
714-289-1100
Email
dvanblitter@nrcresearch.com
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyson Long
Phone
909-792-9007
Email
DLA@andersonstudies.com
Facility Name
ACRC Studies
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Individual Site Status
Withdrawn
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavithra Mukunda
Phone
650-497-2578
Email
pavim@stanford.edu
Facility Name
Collaborative Neuroscience Research
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deidri Gonzalez
Phone
310-523-4200
Email
deidrigonzalez@cnstrial.com
Facility Name
Yale University / Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Kichuk
Phone
203-974-7768
Email
stephen.kichuk@yale.edu
Facility Name
Coastal Connecticut Research, LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Individual Site Status
Withdrawn
Facility Name
Boca Raton Medical Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Thompson
Phone
561-572-3220
Email
rthompson@gminstitutes.com
Facility Name
Advanced Clinical Research Network
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Delgado
Phone
305-702-1594
Email
director@acrntrials.com
Facility Name
Research in Miami Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mirtha Martinez
Phone
305-889-6670
Email
mmartinez@researchinmiami.com
First Name & Middle Initial & Last Name & Degree
Antonio Barreiro
Phone
305-889-6670
Email
abarreiro@researchinmiami.com
Facility Name
Galiz Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Pedraza
Phone
305-805-0921
Email
luisp@galizresearch.com
Facility Name
Accel Research Sites
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Figueroa
Phone
863-940-2087
Email
cfigueroa@meridienresearch.net
Facility Name
Innovative Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Individual Site Status
Withdrawn
Facility Name
ClinCloud, LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Rivas
Phone
386-785-2400
Email
Erivas@accelclinical.com
Facility Name
Pro-Care Research Center
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose M Oquendo
Phone
305-705-4850
Email
j.oquendo@procareresearchcenter.com
Facility Name
South Florida Research Phase I-IV , Inc.
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orlando Sanchez
Phone
305-418-0847
Email
mailto:osanchez@southfloridatrials.com
Facility Name
Health Care Family Rehab & Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Mones
Phone
305-819-3133
Email
EMonesResearch@gmail.com
Facility Name
Central Miami Medical Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo Alonso
Phone
305-547-2011
Email
lalonso@gminstitutes.com
Facility Name
Sanchez Clinical Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maydelis Cruz
Phone
305-234-9484
Email
mcruz@szresearch.us
Facility Name
FIRC
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Gonzalez
Phone
305-909-2505
Email
pgonzalez.firc@gmail.com
Facility Name
Florida Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Y Inclan Ravelo
Phone
786-536-9009
Email
leadcrc@floridarc.net
Facility Name
Bayside Clinical Research, LLC
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Leon
Phone
813-536-3263
Email
Robert@BaysideClinicalResearch.com
Facility Name
Behavioral Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Lapeyra
Phone
305-722-8444
Ext
2248
Email
olapeyra@behavioralclinical.com
Facility Name
Medical Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MRGCF Study Team
Phone
386-775-7627
Email
info@mrgcf.com
Facility Name
APG Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Maboudi
Phone
407-222-9224
Email
HEIDI@APGHEALTH.COM
Facility Name
Combined Research Orlando Phase I-IV
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yenilady Estevez
Phone
407-440-4493
Email
yenilady@clinicaltrialsorlando.com
Facility Name
Omega Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Colon
Phone
407-512-1054
Email
vcolon@omegarcllc.com
Facility Name
IMIC Inc
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Withdrawn
Facility Name
MedBio Trials
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Individual Site Status
Terminated
Facility Name
Lenus Research & Medical Group, LLC
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yelenia Reyno
Phone
305-592-4692
Email
yreyno@lenusresearch.com
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Fowler
Phone
813-971-8311
Email
Susan_fowler@stedmanclinicaltrials.com
Facility Name
Conquest Research LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa O'Neill
Phone
407-848-3845
Email
Melissa.oneill@conquestresearch.com
Facility Name
NeuroTrials Research Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Withdrawn
Facility Name
iResearch Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zach Mitchell
Phone
404-537-1281
Email
Zach.Mitchell@iResearchAtlanta.com
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Harris
Phone
208-685-0600
Email
charris@nwct.com
Facility Name
Uptown Research Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alecia Halstead
Phone
773-989-8313
Ext
119
Email
ahalstead@uptownresearch.com
Facility Name
Revive Research Institute
City
Elgin
State/Province
Illinois
ZIP/Postal Code
60123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jalaal Alzameil
Phone
248-564-1485
Email
jalzameli@rev-research.com
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Individual Site Status
Withdrawn
Facility Name
CBH Health
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Vickerie
Phone
301-873-7649
Email
dvickerie@cbhhealth.com
Facility Name
Pharmasite Research, Inc.
City
Pikesville
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surya Korn
Phone
410-602-1440
Email
surya@pharmasiteresearch.com
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Geller
Phone
617-724-5141
Email
dan.geller@mgh.harvard.edu
Facility Name
ActivMed Practices and Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfaurys Rosario
Phone
978-655-7155
Email
arosario@activmedresearch.com
Facility Name
Sisu at RMG
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marilyn Santiago
Phone
786-267-8166
Email
msantiago@sisuhealth.com
Facility Name
Michigan Clinical Research Institute PC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajaprabhakaran Rajarethinam, MD
Phone
734-834-8954
Email
rpmmc@yahoo.com
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Hall
Phone
601-420-5810
Email
shall@precise-research.com
Facility Name
PsychCare Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikram Datta
Phone
314-849-1853
Ext
202
Email
vikram.datta@pccresearch.org
Facility Name
Altea Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Macedo
Phone
702-527-7401
Email
mmacedo@altearesearch.com
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Ball
Phone
856-753-7335
Email
rball@hritrials.com
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Schindler
Phone
732-244-2299
Email
nancys@bbhnj.com
Facility Name
Integrative Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svetlana Burmakina
Phone
718-444-7774
Email
Svetlana.Burmakina@iclinicaltrials.net
Facility Name
Neurobehavioral Research, Inc
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Pawlowska
Phone
516-295-7230
Email
mpawlowska@NBRresearch.com
Facility Name
Bio Behavioral Institute
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Withdrawn
Facility Name
Bioscience Research, LLC
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naeem Khan
Phone
914-385-0200
Email
Nkhan@bioscienceresearchllc.com
Facility Name
Hapworth Research
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariah Garcia
Phone
212-956-2000
Email
mgarcia@treatmentonline.com
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Smith
Phone
718-317-5522
Ext
301
Email
asmith@ergclinical.com
Facility Name
Clinical Inquest Center, Ltd
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nithiya Iyer
Phone
937-838-4461
Email
nithiya@cic-america.com
Facility Name
NeuroScience Research Center, LLC.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odessa Martin
Phone
330-244-2542
Email
odessam@neurocarecenter.com
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Ellis
Phone
937-424-1050
Email
mellis@ergclinical.com
Facility Name
Central States Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avery Browand
Phone
918-645-5400
Email
AveryB@centralstatesresearch.com
Facility Name
Comprehensive Psychiatric Care Providers
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Wilton
Phone
401-234-2494
Ext
430
Email
swilton@cpccare.com
Facility Name
BioBehavioral Research of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candice Peel
Phone
512-382-6661
Email
candice@bbraustin.com
Facility Name
DiscoveResearch, Inc. (DRI)
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Individual Site Status
Withdrawn
Facility Name
Relaro Medical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee LaRoque
Phone
469-730-3282
Ext
116
Email
rlaroque@relaromedical.com
Facility Name
North Texas Clinical Trials
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Anderson
Phone
817-744-8844
Email
Jessica.anderson@ntxct.com
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Avendano
Phone
713-798-4729
Email
mavendan@bcm.edu
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Eckert
Phone
713-838-2022
Email
stacey.eckert@tcddresearch.com
Facility Name
SMS Clinical Research
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prisilla Fajardo
Phone
972-216-5100
Email
pfajardo@smsclinicalresearch.com
Facility Name
Mt.Olympus Medical Research LLC
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Blanco
Phone
832-805-1197
Email
alberto@mtolympusresearch.com
Facility Name
Grayline Research Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Castro
Phone
940-322-1131
Email
kcastro@graylinecdt.com
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirin Schilling
Phone
425-453-0404
Email
sschilling@nwcrc.net

12. IPD Sharing Statement

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Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

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