CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
iclepertin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion criteria
- Signed and dated written informed consent.
- Male or female patients who are 18-50 years (inclusive) of age at time of consent.
Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).
-- Patients must be clinically stable and in the residual (non-acute) phase of their illness with no hospitalization or increase level of care due to worsening of schizophrenia in the past 12 weeks or no uncontrolled positive symptoms.
- Patients should have functional impairment in day-to-day activities per investigator judgement.
- Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.
- Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization.
- Women of childbearing potential must use highly effective methods of birth control.
- Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply.
Exclusion criteria
- Patient with current DSM-5 diagnosis other than Schizophrenia.
- Cognitive impairment due to other causes, or patients with dementia.
- Severe movement disorders.
- Any suicidal behavior in past year or suicidal ideation in the past 3 months.
- History of moderate or severe substance use disorder within the last 12 months prior to informed consent.
- Positive urine drug screen.
- Patients who were treated with Clozapine, stimulants, ketamine or electroconvulsive therapy within 6 months prior to randomization.
- Current participation in any investigational drug trial.
- Cognitive Remediation Therapy within 12 weeks prior to screening.
- Initiation or change in any type or frequency of psychotherapy within 12 weeks prior to randomization.
- Any clinically significant finding or condition that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
- Haemoglobin (Hb) below lower limit of normal .
- History of haemolytic anaemia, red blood cell (RBC) membrane diseases, known Glucose-6-phosphate dehydrogenase deficiency, anaemia of any cause or patients planning to donate blood.
- Severe renal impairment.
- Indication of liver disease.
- Any documented active or suspected malignancy or history of malignancy within 5 years.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Further exclusion criteria apply.
Sites / Locations
- Advanced Research Center, Inc.Recruiting
- ProScience Research GroupRecruiting
- Sunwise Clinical ResearchRecruiting
- University of California Los AngelesRecruiting
- CNRI - Los AngelesRecruiting
- Stanford University Medical CenterRecruiting
- Advanced Medical Research Group IncRecruiting
- University of MiamiRecruiting
- Ivetmar Medical Group, LLCRecruiting
- Nova Psychiatry Inc.Recruiting
- Synexus Clinical ResearchRecruiting
- Augusta UniversityRecruiting
- Center for Behavioral Health, LLC
- Arch Clinical Trials, LLCRecruiting
- Omaha Insomnia and Psychiatric ServicesRecruiting
- Hassman Research InstituteRecruiting
- UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research CenterRecruiting
- Midwest Clinical ResearchRecruiting
- Rivus Wellness and Research InstituteRecruiting
- Cutting Edge Research GroupRecruiting
- Ben Taub General HospitalRecruiting
- LinQ Research, LLCRecruiting
- Clínica Privada BanfieldRecruiting
- Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)Recruiting
- Instituto Médico DAMIC S.R.L.Recruiting
- Instituto Modelo de Neurología LennoxRecruiting
- Instituto de Neurociencias San AgustínRecruiting
- Instituto Médico de la Fundación Estudios ClínicosRecruiting
- Centro Medico LuquezRecruiting
- Medical University of InnsbruckRecruiting
- AKH - Medical University of ViennaRecruiting
- CUP Vivalia -La ClairièreRecruiting
- Sint-KamillusRecruiting
- Universitair Psychiatrisch Centrum Duffel (UPC Duffel)Recruiting
- Beijing Anding HospitalRecruiting
- The Second Xiangya Hospital Of Central South UniversityRecruiting
- 3rd Affiliated Hosp of Sun yet-sen UniversityRecruiting
- Huzhou Third Municipal HospitalRecruiting
- Brain Hospital Affiliated to Nanjing Med UniversityRecruiting
- Shenzhen Kangning HospitalRecruiting
- The First Hospital of Hebei Medical UniversityRecruiting
- Tianjin Anding HospitalRecruiting
- First Affiliated Hospital of Xi'an JiaoTong UniversityRecruiting
- Xi'an Mental Health CenterRecruiting
- Zhumadian Psychiatric HospitalRecruiting
- National Institute of Mental HealthRecruiting
- MPMeditrine s.r.o.Recruiting
- A-SHINE s.r.oRecruiting
- PRAGTIS s.r.o.Recruiting
- INEP medical s.r.o.Recruiting
- Psychiatrie Ricany s.r.o.Recruiting
- Aalborg UniversitetsshospitalRecruiting
- Aarhus University HospitalRecruiting
- Psykiatrisk Center GlostrupRecruiting
- HUS Jorvi HospitalRecruiting
- Aurora hospitalRecruiting
- CRST - Clinical Research Services TurkuRecruiting
- Studienzentrum für Neurologie und PsychiatrieRecruiting
- Pharmakologisches Studienzentrum Chemnitz GmbHRecruiting
- Universitätsmedizin der Johannes Gutenberg-Universität MainzRecruiting
- Klinikum der Universität München - Campus InnenstadtRecruiting
- Inje University Busan Paik HospitalRecruiting
- Yeungnam University Medical CenterRecruiting
- Chonnam National University HospitalRecruiting
- CHA Bundang Medical CenterRecruiting
- Seoul National University Bundang HospitalRecruiting
- Pusan National University Yangsan HospitalRecruiting
- JSC Romuvos ClinicRecruiting
- LUHS KH Psichiatric Clinic Mariu DivisionRecruiting
- JSC Medical center "Puriena"
- Vilnius City Mental Health CenterRecruiting
- Centro de Investigacion Integral MEDIVEST S.CRecruiting
- Centro de Investigación Clinica Acelerada, S.C.Recruiting
- Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.Recruiting
- Hospital Aranda de la ParraRecruiting
- Iecsi S.C.Recruiting
- Hospital Universitario Dr Jose Eleuterio GonzalezRecruiting
- BIND Investigaciones S.C.Recruiting
- Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa MariaRecruiting
- Clinical Hospital Center Dr. Dragisa MisovicRecruiting
- General Hospital EuromedikRecruiting
- University Clinical Center of SerbiaRecruiting
- Special Hospital for Psychiatric Diseases Gornja ToponicaRecruiting
- Special Hospital for Psychiatric Diseases KovinRecruiting
- University Clinical Center of KragujevacRecruiting
- Kai-Syuan Psychiatric HospitalRecruiting
- Chang Gung Memorial Hospital KeelungRecruiting
- Chung Shan Medical University HospitalRecruiting
- NCKUHRecruiting
- National Taiwan University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- Tri-Service General HospitalRecruiting
- Chang Gung Memorial Hospital(Linkou)Recruiting
- Taoyuan Psychiatric CenterRecruiting
- Bodmin Community HospitalRecruiting
- The Fritchie CentreRecruiting
- RedesmereRecruiting
- Western General HospitalRecruiting
- Queen Elizabeth University HospitalRecruiting
- Warneford HospitalRecruiting
- Moorgreen HospitalRecruiting
- Foss Park HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Iclepertin treatment group
Placebo group
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) consensus cognitive battery (MCCB)
MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition
Secondary Outcome Measures
Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score
SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functioning. Each item is rated on a 4-point scale. Higher ratings reflect a greater degree of impairment.
Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London
Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score
PRECIS is a patient reported outcome (PRO) for recording patients' subjective experience of Cognitive Impairment Associated with Schizophrenia (CIAS). The questionnaire contains 28 items covering 6 domains: Memory (6 items), communication (4 items), self-control (3 items), executive function (4 items), attention (6 items), and sharp thinking (3 items). Two additional items assess the overall degree of bother associated with all domains. Questions are answered via a 5-category Likert scale, with higher scores corresponding to worse patient experience. The Total Score is derived by calculating the simple average score of the first 26 items.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04860830
Brief Title
CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia
Official Title
A Phase III Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of Iclepertin Once Daily Over 26 Week Treatment Period in Patients With Schizophrenia (CONNEX-3)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
January 3, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
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
This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called iclepertin improves learning and memory in people with schizophrenia.
Participants are put into two groups randomly, which means by chance. One group takes iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia.
During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups.
Participants are in the study for about 8 months and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
586 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iclepertin treatment group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
iclepertin
Intervention Description
iclepertin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) consensus cognitive battery (MCCB)
Description
MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition
Time Frame
After 26 weeks of treatment
Secondary Outcome Measure Information:
Title
Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score
Description
SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functioning. Each item is rated on a 4-point scale. Higher ratings reflect a greater degree of impairment.
Time Frame
After 26 weeks of treatment
Title
Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Time Frame
Up to week 26
Title
Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London
Time Frame
Up to week 26
Title
Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score
Description
PRECIS is a patient reported outcome (PRO) for recording patients' subjective experience of Cognitive Impairment Associated with Schizophrenia (CIAS). The questionnaire contains 28 items covering 6 domains: Memory (6 items), communication (4 items), self-control (3 items), executive function (4 items), attention (6 items), and sharp thinking (3 items). Two additional items assess the overall degree of bother associated with all domains. Questions are answered via a 5-category Likert scale, with higher scores corresponding to worse patient experience. The Total Score is derived by calculating the simple average score of the first 26 items.
Time Frame
Up to week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Signed and dated written informed consent.
Male or female patients who are 18-50 years (inclusive) of age at time of consent.
Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).
-- Patients must be clinically stable and in the residual (non-acute) phase of their illness with no hospitalization or increase level of care due to worsening of schizophrenia in the past 12 weeks or no uncontrolled positive symptoms.
Patients should have functional impairment in day-to-day activities per investigator judgement.
Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.
Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization.
Women of childbearing potential must use highly effective methods of birth control.
Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply.
Exclusion criteria
Patient with current DSM-5 diagnosis other than Schizophrenia.
Cognitive impairment due to other causes, or patients with dementia or epilepsy.
Severe movement disorders.
Any suicidal behavior in past year or suicidal ideation in the past 3 months.
History of moderate or severe substance use disorder within the last 12 months prior to informed consent.
Positive urine drug screen.
Patients who were treated with Clozapine, stimulants, ketamine or electroconvulsive therapy within 6 months prior to randomization.
Current participation in any investigational drug trial.
Cognitive Remediation Therapy within 12 weeks prior to screening.
Initiation or change in any type or frequency of psychotherapy within 12 weeks prior to randomization.
Any clinically significant finding or condition that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
Haemoglobin (Hb) below lower limit of normal .
History of haemolytic anaemia, red blood cell (RBC) membrane diseases, known Glucose-6-phosphate dehydrogenase deficiency, anaemia of any cause or patients planning to donate blood.
Severe renal impairment.
Indication of liver disease.
Any documented active or suspected malignancy or history of malignancy within 5 years.
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Further exclusion criteria apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
Facility Information:
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
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Sunwise Clinical Research
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
CNRI - Los Angeles
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Advanced Medical Research Group Inc
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Ivetmar Medical Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Nova Psychiatry Inc.
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
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Synexus Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Center for Behavioral Health, LLC
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Individual Site Status
Suspended
Facility Name
Arch Clinical Trials, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Omaha Insomnia and Psychiatric Services
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.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
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Midwest Clinical Research
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
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Rivus Wellness and Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Ben Taub General Hospital
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
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
LinQ Research, LLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Clínica Privada Banfield
City
Banfield
ZIP/Postal Code
B1228CKR
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
City
Caba
ZIP/Postal Code
C1133AAH
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Instituto Médico DAMIC S.R.L.
City
Cordoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Instituto Modelo de Neurología Lennox
City
Córdoba
ZIP/Postal Code
X5000FAL
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Instituto de Neurociencias San Agustín
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Instituto Médico de la Fundación Estudios Clínicos
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Centro Medico Luquez
City
San Vicente
ZIP/Postal Code
X5006CBI
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Medical University of Innsbruck
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800017900
Email
oesterreich@bitrialsupport.com
Facility Name
AKH - Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800017900
Email
oesterreich@bitrialsupport.com
Facility Name
CUP Vivalia -La Clairière
City
Bertix
ZIP/Postal Code
6880
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
080049616
Email
belgique@bitrialsupport.com
Facility Name
Sint-Kamillus
City
Bierbeek
ZIP/Postal Code
3360
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
080049616
Email
belgique@bitrialsupport.com
Facility Name
Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
City
Duffel
ZIP/Postal Code
2570
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
080049616
Email
belgique@bitrialsupport.com
Facility Name
Beijing Anding Hospital
City
Beijing
ZIP/Postal Code
100088
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
The Second Xiangya Hospital Of Central South University
City
Changsha
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
3rd Affiliated Hosp of Sun yet-sen University
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Huzhou Third Municipal Hospital
City
Huzhou
ZIP/Postal Code
313000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Brain Hospital Affiliated to Nanjing Med University
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Shenzhen Kangning Hospital
City
Shenzhen
ZIP/Postal Code
518003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
ZIP/Postal Code
050030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Tianjin Anding Hospital
City
Tianjin
ZIP/Postal Code
300202
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
First Affiliated Hospital of Xi'an JiaoTong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Xi'an Mental Health Center
City
Xi'an
ZIP/Postal Code
710101
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Zhumadian Psychiatric Hospital
City
Zhumadian
ZIP/Postal Code
463000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
National Institute of Mental Health
City
Klecany
ZIP/Postal Code
25067
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
MPMeditrine s.r.o.
City
Ostrava-Poruba
ZIP/Postal Code
708 68
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
A-SHINE s.r.o
City
Plzen
ZIP/Postal Code
30100
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
PRAGTIS s.r.o.
City
Prague
ZIP/Postal Code
120 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
INEP medical s.r.o.
City
Prague
ZIP/Postal Code
18600
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
Psychiatrie Ricany s.r.o.
City
Ricany
ZIP/Postal Code
251 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
Aalborg Universitetsshospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80711822
Email
danmark@bitrialsupport.com
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80711822
Email
danmark@bitrialsupport.com
Facility Name
Psykiatrisk Center Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80711822
Email
danmark@bitrialsupport.com
Facility Name
HUS Jorvi Hospital
City
Espoo
ZIP/Postal Code
2740
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800918118
Email
suomi@bitrialsupport.com
Facility Name
Aurora hospital
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800918118
Email
suomi@bitrialsupport.com
Facility Name
CRST - Clinical Research Services Turku
City
Turku
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800918118
Email
suomi@bitrialsupport.com
Facility Name
Studienzentrum für Neurologie und Psychiatrie
City
Böblingen
ZIP/Postal Code
71034
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Pharmakologisches Studienzentrum Chemnitz GmbH
City
Chemnitz
ZIP/Postal Code
09111
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Klinikum der Universität München - Campus Innenstadt
City
München
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0808802084
Email
namhan@bitrialsupport.com
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0808802084
Email
namhan@bitrialsupport.com
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61453
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0808802084
Email
namhan@bitrialsupport.com
Facility Name
CHA Bundang Medical Center
City
Seongnam
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0808802084
Email
namhan@bitrialsupport.com
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0808802084
Email
namhan@bitrialsupport.com
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0808802084
Email
namhan@bitrialsupport.com
Facility Name
JSC Romuvos Clinic
City
Kaunas
ZIP/Postal Code
LT-44279
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80080099
Email
lithuania@bitrialsupport.com
Facility Name
LUHS KH Psichiatric Clinic Mariu Division
City
Kaunas
ZIP/Postal Code
LT-53137
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80080099
Email
lithuania@bitrialsupport.com
Facility Name
JSC Medical center "Puriena"
City
Silute
ZIP/Postal Code
LT-99142
Country
Lithuania
Individual Site Status
Suspended
Facility Name
Vilnius City Mental Health Center
City
Vilnius
ZIP/Postal Code
LT-10309
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80080099
Email
lithuania@bitrialsupport.com
Facility Name
Centro de Investigacion Integral MEDIVEST S.C
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Centro de Investigación Clinica Acelerada, S.C.
City
Ciudad de Mexico
ZIP/Postal Code
07369
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
City
Culiacan
ZIP/Postal Code
80230
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Hospital Aranda de la Parra
City
Leon
ZIP/Postal Code
37000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Iecsi S.C.
City
Monterrey
ZIP/Postal Code
64310
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
BIND Investigaciones S.C.
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800856070
Email
portugal@bitrialsupport.com
Facility Name
Clinical Hospital Center Dr. Dragisa Misovic
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800800636
Email
srbija@bitrialsupport.com
Facility Name
General Hospital Euromedik
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800800636
Email
srbija@bitrialsupport.com
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800800636
Email
srbija@bitrialsupport.com
Facility Name
Special Hospital for Psychiatric Diseases Gornja Toponica
City
Gornja Toponica
ZIP/Postal Code
18202
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800800636
Email
srbija@bitrialsupport.com
Facility Name
Special Hospital for Psychiatric Diseases Kovin
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800800636
Email
srbija@bitrialsupport.com
Facility Name
University Clinical Center of Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800800636
Email
srbija@bitrialsupport.com
Facility Name
Kai-Syuan Psychiatric Hospital
City
Kaohsiung
ZIP/Postal Code
802
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0809092098
Email
taiwan@bitrialsupport.com
Facility Name
Chang Gung Memorial Hospital Keelung
City
Keelung
ZIP/Postal Code
20401
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0809092098
Email
taiwan@bitrialsupport.com
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0809092098
Email
taiwan@bitrialsupport.com
Facility Name
NCKUH
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0809092098
Email
taiwan@bitrialsupport.com
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10016
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0809092098
Email
taiwan@bitrialsupport.com
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0809092098
Email
taiwan@bitrialsupport.com
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0809092098
Email
taiwan@bitrialsupport.com
Facility Name
Chang Gung Memorial Hospital(Linkou)
City
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0809092098
Email
taiwan@bitrialsupport.com
Facility Name
Taoyuan Psychiatric Center
City
Taoyuan
ZIP/Postal Code
33058
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0809092098
Email
taiwan@bitrialsupport.com
Facility Name
Bodmin Community Hospital
City
Bodmin
ZIP/Postal Code
PL31 2QT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
Facility Name
The Fritchie Centre
City
Cheltenham
ZIP/Postal Code
GL53 9DZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
Facility Name
Redesmere
City
Chester
ZIP/Postal Code
CH2 1BQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
Facility Name
Warneford Hospital
City
Oxford
ZIP/Postal Code
OX3 7JX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
Facility Name
Moorgreen Hospital
City
Southampton
ZIP/Postal Code
SO30 3JB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
Facility Name
Foss Park Hospital
City
York
ZIP/Postal Code
YO31 8TA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000514022
Email
unitedkingdom@bitrialsupport.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info
Learn more about this trial
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