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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003154-23 | EudraCT Number |
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This study is open to people aged 18 to 65 who have post-traumatic stress disorder. The purpose of this study is to find out whether a medicine called BI 1358894 improves symptoms in people with post-traumatic stress disorder.
Participants are put into 2 groups randomly, which means by chance. Participants take BI 1358894 or placebo as tablets every day for 2 months. Placebo tablets look like BI 1358894 tablets but do not contain any medicine.
Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 4 phone calls from the trial staff. During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether their symptoms change.
The doctors also regularly check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1358894 125 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1358894 | Drug | BI 1358894 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale for DSM-5 (CAPS-5) Total Severity Score at Week 8 | CAPS-5 is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity. Least Squares (LS) means and confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used. | The MMRM model is a longitudinal analysis and it incorporated CAPS-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported. |
| Measure | Description | Time Frame |
|---|---|---|
| CAPS-5 Response, Defined as ≥30% CAPS-5 Reduction From Baseline at Week 8 | Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity. Number of participants with ≥30% CAPS-5 reduction from baseline at Week 8 is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group, Inc. | Little Rock | Arkansas | 72211 | United States | ||
| Behavioral Research Specialists, LLC |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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.
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.
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'.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This was a Phase II, 8-week-treatment, multicentre, randomised, double blind, placebocontrolled, parallel-group trial in patients with Post-Traumatic Stress Disorder (PTSD).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients received orally, once daily for 8 consecutive weeks film-coated tablets of placebo matching BI 1358894. Placebo matching BI 1358894 was administered with water and in a consistent way, i.e. either with or without food every morning at approximately the same time. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2023 | Oct 8, 2024 |
Not provided
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| Drug |
Placebo |
|
| At baseline and at 8 weeks after start of treatment. |
| CAPS-5 Response, Defined as ≥50% CAPS-5 Reduction From Baseline at Week 8 | Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity. Number of participants with ≥50% CAPS-5 reduction from baseline at Week 8 is reported. | At baseline and at 8 weeks after start of treatment. |
| Change From Baseline on the PTSD Checklist for DSM-5 (PCL-5) Total Score at Week 8 | The PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (PCL-5) is a 20-item patient-reported assessment designed to measure the presence and severity of PTSD symptoms in the past month. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Each item is rated on a five point Likert scale, from 0 (not at all) to 4 (extremely) yielding a total score from 0-80 with higher scores indicating higher severity of the symptoms. Least Square (LS) means and confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used. | The MMRM model is a longitudinal analysis and it incorporated PCL-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported. |
| Glendale |
| California |
| 91206 |
| United States |
| ASCLEPES Research Centers, P.C. dba Alliance Research | Long Beach | California | 90807 | United States |
| CalNeuro Research Group Inc. | Los Angeles | California | 90025 | United States |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | United States |
| Artemis Institute for Clinical Research, LLC | San Diego | California | 92103 | United States |
| Clinical Innovations Inc. | Santa Ana | California | 92705 | United States |
| California Neuroscience Research | Sherman Oaks | California | 91403 | United States |
| Collaborative Neuroscience Research, LLC | Torrance | California | 90504 | United States |
| Mountain Mind. LLC | Denver | Colorado | 80202 | United States |
| CNS Clinical Research - Coral Springs | Coral Springs | Florida | 33067 | United States |
| Innovative Clinical Research | Lauderhill | Florida | 33319 | United States |
| Miami Dade Medical Research Institute, LLC | Miami | Florida | 33176 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| Elixia PHC, LLC | St. Petersburg | Florida | 33713 | United States |
| Institute for Advanced Medical Research | Alpharetta | Georgia | 30022 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| American Medical Research | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Pharmasite Research, Incorporated | Baltimore | Maryland | 21208 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Sisu BHR, LLC | Springfield | Massachusetts | 01103 | United States |
| NeuroBehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Center For Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Insight Clinical Trials | Beachwood | Ohio | 44122 | United States |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | United States |
| The University of Texas at Austin | Austin | Texas | 78712 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| Relaro Medical Trials, LLC | Dallas | Texas | 75243 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| Audie L. Murphy VA Hospital | San Antonio | Texas | 78229 | United States |
| Grayline Research Center | Wichita Falls | Texas | 76309 | United States |
| Salem VA Medical Center | Salem | Virginia | 24153 | United States |
| Clincal Hospital Centre Rijeka | Rijeka | 51 000 | Croatia |
| Polyclinic Neuron | Zagreb | 10000 | Croatia |
| Solmed Polyclinic | Zagreb | 10000 | Croatia |
| Psychiatric Hospital 'Sveti Ivan' | Zagreb | 10090 | Croatia |
| University Psychiatric Hospital Vrapce | Zagreb | 10090 | Croatia |
| Eira Medical Centre | Helsinki | 00150 | Finland |
| Oulu Mentalcare Oy | Oulu | 90100 | Finland |
| Mehiläinen Tampere | Tampere | FI-33210 | Finland |
| Universitätsklinikum Aachen, AöR | Aachen | 52074 | Germany |
| Zentralinstitut für seelische Gesundheit | Mannheim | 68159 | Germany |
| Klinikum der Universität München - Campus Innenstadt | München | 80336 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| The Chaim Sheba Medical Center Tel HaShomer | Tel Litwinsky | 52621 | Israel |
| Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C. | Culiacán | 80230 | Mexico |
| Hospital Aranda de la Parra | León | 37000 | Mexico |
| CIT-Neuropsique S.C | Monterrey | 64610 | Mexico |
| BIND Investigaciones S.C. | San Luis Potosí City | 78213 | Mexico |
| MlynowaMed | Bialystok | 15-404 | Poland |
| In-Vivo Sp. Z o.o. | Bydgoszcz | 85-048 | Poland |
| MTZ Clinical Research Powered by Pratia | Warsaw | 02-172 | Poland |
| Psykiatri Södra Stockholm | Enskede | 122 31 | Sweden |
| Psykiatri Affektiva sjukdomar | Gothenburg | 416 50 | Sweden |
| Psykiatri Sydväst Stockholm | Huddinge/Stockholm | 141 86 | Sweden |
| Akademiska sjukhuset | Uppsala | 751 85 | Sweden |
| BI 1358894 125 mg |
Patients received orally, once daily for 8 consecutive weeks 125 milligrams (mg) of BI 1358894. The dosage of 125 milligrams consisted of two film-coated tablets of 50 mg and 1 film-coated tablet of 25 mg. BI 135889 was administered with water and in a consistent way, i.e. either with or without food every morning at approximately the same time. |
| Treated |
|
| COMPLETED | completed planned treatment |
|
| NOT COMPLETED |
|
|
Treated Set (TS): consisted of all patients that were randomised and had received at least one administration of trial drug. Patients were analysed according to the actual received treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients received orally, once daily for 8 consecutive weeks film-coated tablets of placebo matching BI 1358894. Placebo matching BI 1358894 was administered with water and in a consistent way, i.e. either with or without food every morning at approximately the same time. |
| BG001 | BI 1358894 125 mg | Patients received orally, once daily for 8 consecutive weeks 125 milligrams (mg) of BI 1358894. The dosage of 125 milligrams consisted of two film-coated tablets of 50 mg and 1 film-coated tablet of 25 mg. BI 135889 was administered with water and in a consistent way, i.e. either with or without food every morning at approximately the same time. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| CAPS-5 total severity score at baseline | Clinician-administered Post Traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. The CAPS-5 as used in this trial has 20 items, each scored 0-4, to yield a score with a possible range of 0-80. Higher scores mean worse outcome. | Mean | Standard Deviation | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale for DSM-5 (CAPS-5) Total Severity Score at Week 8 | CAPS-5 is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity. Least Squares (LS) means and confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used. | Full analysis set (FAS): consisted of all patients in the treated set (TS) that had a baseline and at least one evaluable post-baseline measurement for the primary endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | The MMRM model is a longitudinal analysis and it incorporated CAPS-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CAPS-5 Response, Defined as ≥30% CAPS-5 Reduction From Baseline at Week 8 | Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity. Number of participants with ≥30% CAPS-5 reduction from baseline at Week 8 is reported. | Full analysis set (FAS): consisted of all patients in the treated set (TS) that had a baseline and at least one evaluable post-baseline measurement for the primary endpoint. Only participants with data from baseline and from Week 8 were included in the analysis of this endpoint. | Posted | Count of Participants | Participants | At baseline and at 8 weeks after start of treatment. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CAPS-5 Response, Defined as ≥50% CAPS-5 Reduction From Baseline at Week 8 | Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity. Number of participants with ≥50% CAPS-5 reduction from baseline at Week 8 is reported. | Full analysis set (FAS): consisted of all patients in the treated set (TS) that had a baseline and at least one evaluable post-baseline measurement for the primary endpoint. Only participants with data from baseline and from Week 8 were included in the analysis of this endpoint. | Posted | Count of Participants | Participants | At baseline and at 8 weeks after start of treatment. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on the PTSD Checklist for DSM-5 (PCL-5) Total Score at Week 8 | The PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (PCL-5) is a 20-item patient-reported assessment designed to measure the presence and severity of PTSD symptoms in the past month. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Each item is rated on a five point Likert scale, from 0 (not at all) to 4 (extremely) yielding a total score from 0-80 with higher scores indicating higher severity of the symptoms. Least Square (LS) means and confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used. | Full analysis set (FAS): consisted of all patients in the TS that had a baseline and at least one evaluable post-baseline measurement for the primary endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | The MMRM model is a longitudinal analysis and it incorporated PCL-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported. |
|
"All-Cause Mortality" "Serious Adverse Events" and "Other Adverse Events": From first administration of BI 1358894 or placebo to last administration of BI 1358894 or placebo + 4 weeks of residual effect period, up to 13 weeks.
Treated Set (TS): consisted of all patients that were randomised and had received at least one administration of trial drug. Patients were analysed according to the actual received treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients received orally, once daily for 8 consecutive weeks film-coated tablets of placebo matching BI 1358894. Placebo matching BI 1358894 was administered with water and in a consistent way, i.e. either with or without food every morning at approximately the same time. | 1 | 159 | 10 | 159 | 38 | 159 |
| EG001 | BI 1358894 125 mg | Patients received orally, once daily for 8 consecutive weeks 125 milligrams (mg) of BI 1358894. The dosage of 125 milligrams consisted of two film-coated tablets of 50 mg and 1 film-coated tablet of 25 mg. BI 135889 was administered with water and in a consistent way, i.e. either with or without food every morning at approximately the same time. | 0 | 157 | 12 | 157 | 56 | 157 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematochezia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 21, 2023 | Oct 8, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000730434 | TRPC inhibitor BI 1358894 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Patients received orally, once daily for 8 consecutive weeks 125 milligrams (mg) of BI 1358894. The dosage of 125 milligrams consisted of two film-coated tablets of 50 mg and 1 film-coated tablet of 25 mg. BI 135889 was administered with water and in a consistent way, i.e. either with or without food every morning at approximately the same time.
|
|
|
Patients received orally, once daily for 8 consecutive weeks 125 milligrams (mg) of BI 1358894. The dosage of 125 milligrams consisted of two film-coated tablets of 50 mg and 1 film-coated tablet of 25 mg. BI 135889 was administered with water and in a consistent way, i.e. either with or without food every morning at approximately the same time.
|
|
|
| OG001 | BI 1358894 125 mg | Patients received orally, once daily for 8 consecutive weeks 125 milligrams (mg) of BI 1358894. The dosage of 125 milligrams consisted of two film-coated tablets of 50 mg and 1 film-coated tablet of 25 mg. BI 135889 was administered with water and in a consistent way, i.e. either with or without food every morning at approximately the same time. |
|
|
|