A Phase 2 interventional study of BI 1358894 and Placebo in Borderline Personality Disorder, sponsored by Boehringer Ingelheim. Completed at 67 sites in 15 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
This study is open to adults with borderline personality disorder. The purpose of this study is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with borderline personality disorder. Four different doses of BI 1358894 are tested in the study.
Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take different doses of BI 1358894. Participants in the fifth group take placebo. Participants take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894 tablets but do not contain any medicine.
Participants are in the study for about 5 months. During this time, they visit the study site about 12 times and get about 6 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups and the placebo group are then compared. The doctors also regularly check the general health of the participants.
336 studies on the registry are indexed under Personality Disorders; 48 are open to participants now.
This study's enrollment of 390 is above the median of 75 across 229 interventional studies indexed under Personality Disorders.
Browse Personality Disorders studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women of childbearing potential (WOCBP) able and willing to use two methods of contraception, as confirmed by the investigator, which include one highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1%, plus one barrier method.
--A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal occlusion/ ligation is NOT a method of permanent sterilization. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Exclusion Criteria:
Drug: BI 1358894
Drug: BI 1358894
Drug: BI 1358894
Drug: BI 1358894
Drug: Placebo
Film-coated tablet
Film-coated tablet
Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10
The ZAN-BPD scale reflects the nine DSM-5 criteria and the scale has 4 domain scores that reflect core areas of BPD (i.e., affective, cognitive, impulsive and interpersonal symptoms). The ZAN-BPD scale includes a 5-point rating scale (i.e., 0 = no symptoms to 4 = severe symptoms) for each criterion. The total ZAN-BPD score is the sum of the 4 domain scores and ranges from 0 to 36 where higher scores mean severe symptoms. Least Squares (LS) mean and standard error were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8 and 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS mean (standard error) for Week 10 are reported.
Time frame: The change from baseline at Week 10 in the total ZAN-BPD score was calculated using the MMRM model which is a longitudinal analyses and it incorporates ZAN-BPD measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.
ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Response: Defined as ≥30% ZAN-BPD Reduction From Baseline at Week 10
Number of participants with ZAN-BPD response is reported. ZAN-BPD response was defined as ≥30% ZAN-BPD reduction from baseline at Week 10. The ZAN-BPD scale reflects the nine DSM-5 criteria, and the scale has 4 domain scores that reflect core areas of BPD (i.e., affective, cognitive, impulsive and interpersonal symptoms). The ZAN-BPD scale includes a 5-point rating scale (i.e., 0 = no symptoms to 4 = severe symptoms) for each criterion. The total ZAN-BPD score is the sum of the 4 domain scores and ranges from 0 to 36 where higher scores mean severe symptoms.
Time frame: Baseline and at Week 10.
Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at Week 10
The DERS is a self-report measure of emotion regulation difficulties. It consists of 16 items that assess non-acceptance of negative emotions, inability to engage in goal-directed behaviors when distressed, difficulties controlling impulsive behaviors when distressed, limited access to emotion regulation strategies perceived as effective, and lack of emotional clarity. Each item is scored from 1 (almost never (0-10%)) to 5 (almost always (91-100%)). Total DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation. Least Squares (LS) mean and standard error were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8 and 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS mean (standard error) for Week 10 are reported.
Time frame: Change from baseline in DERS-16 total score at Week 10 was calculated using the MMRM model which is a longitudinal analyses and it incorporates DERS-16 measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.
Change From Baseline in State-Trait Anxiety Inventory (STAI-S) Total Score at Week 10
The STAI-S consists of 20 item state anxiety questions that evaluate how respondents feel "right now, at this moment". All items are rated on a weighted score of 1 to 4 scale (e.g. from 'Almost Never to 'Almost Always'); with higher scores indicating greater anxiety. STAI-S score ranges from 20 to 80 where higher scores indicate greater anxiety. Least Squares (LS) mean and standard error were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS mean (standard error) for Week 10 are reported.
Time frame: Change from baseline in STAI-S total score at Week 10 was calculated using the MMRM model which is a longitudinal analyses and it incorporates STAI-S measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Week 10
The PHQ-9 is a 9-item brief self-reported tool used for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 has a maximum total score of 27. Depression Severity is assessed as: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), or severe (20-27). Least Squares (LS) mean and standard error were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS mean (standard error) for Week 10 are reported.
Time frame: Change from baseline in PHQ-9 total score at Week 10 was calculated using the MMRM model which is a longitudinal analyses and it incorporates PHQ-9 measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10
The CGI-S rating scale measures the clinician's impression of the severity of illness exhibited by a participant. The CGI-S only question states "Considering your total clinical experience with this particular population, please choose the response below that best describes how mentally ill the patient was over the past week?", and is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Least Squares (LS) mean and standard error were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS mean (standard error) for Week 10 are reported.
Time frame: Change from baseline in CGI-S scale at Week 10 was calculated using the MMRM model which is a longitudinal analyses and it incorporates CGI-S measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.
Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10
The PGI-S measures the patient's impression of the severity of their illness. It is a single item 5-point scale that asks patients to rate the severity of their illness. The PGI-S question states "Please choose the response below that best describes the overall severity of your symptoms of Borderline Personality Disorder at this time. (Select one response)": 1=No symptoms; 2=Mild; 3=Moderate; 4=Severe; 5=Very severe. Least Squares (LS) mean and standard error were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8,10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS means (standard error) for Week 10 are reported.
Time frame: Change from baseline in PGI-S scale at Week 10 was calculated using the MMRM model which is a longitudinal analyses and it incorporates PGI-S measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.
This was a Phase II, 12-week multicenter, multinational, randomised, double-blind, placebo-controlled, parallel-group trial in patients with borderline personality disorder (BPD). Eligible patients with BPD were randomised to receive either BI 1358894 or placebo in a 2.5:1:1:1:2 ratio (placebo or BI 1358894 5 milligram (mg), 25 mg, 75 mg, or 125 mg), for 12 weeks. This trial included a screening period, a 12-week randomised treatment period, and a 4-week follow-up period.
| Milestone | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg |
|---|---|---|---|---|---|
| Started | 128 | 52 | 53 | 53 | 104 |
| Completed | 95 | 40 | 35 | 40 | 77 |
| Not completed | 33 | 12 | 18 | 13 | 27 |
| Withdrew: Other than listed | 13 | 4 | 2 | 1 | 4 |
| Withdrew: Protocol deviation | 3 | 0 | 1 | 1 | 1 |
| Withdrew: Technical problems | 0 | 0 | 1 | 0 | 0 |
| Withdrew: No reason available | 3 | 2 | 7 | 1 | 5 |
| Withdrew: Burden of study procedures | 3 | 0 | 0 | 3 | 1 |
| Withdrew: Change of residence | 2 | 2 | 0 | 1 | 2 |
| Withdrew: Perceived lack of efficacy | 2 | 0 | 1 | 1 | 2 |
| Withdrew: Adverse event | 7 | 4 | 6 | 5 | 12 |
The ZAN-BPD scale reflects the nine DSM-5 criteria and the scale has 4 domain scores that reflect core areas of BPD (i.e., affective, cognitive, impulsive and interpersonal symptoms). The ZAN-BPD scale includes a 5-point rating scale (i.e., 0 = no symptoms to 4 = severe symptoms) for each criterion. The total ZAN-BPD score is the sum of the 4 domain scores and ranges from 0 to 36 where higher scores mean severe symptoms. Least Squares (LS) mean and standard error were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8 and 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS mean (standard error) for Week 10 are reported.
| units on a scale | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg |
|---|---|---|---|---|---|
| Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10 | -8.7 ± 0.5 | -8.0 ± 0.9 | -9.2 ± 0.9 | -8.9 ± 0.8 | -9.0 ± 0.6 |
Number of participants with ZAN-BPD response is reported. ZAN-BPD response was defined as ≥30% ZAN-BPD reduction from baseline at Week 10. The ZAN-BPD scale reflects the nine DSM-5 criteria, and the scale has 4 domain scores that reflect core areas of BPD (i.e., affective, cognitive, impulsive and interpersonal symptoms). The ZAN-BPD scale includes a 5-point rating scale (i.e., 0 = no symptoms to 4 = severe symptoms) for each criterion. The total ZAN-BPD score is the sum of the 4 domain scores and ranges from 0 to 36 where higher scores mean severe symptoms.
| Participants | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg |
|---|---|---|---|---|---|
| ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Response: Defined as ≥30% ZAN-BPD Reduction From Baseline at Week 10 | 68 | 22 | 28 | 34 | 59 |
The DERS is a self-report measure of emotion regulation difficulties. It consists of 16 items that assess non-acceptance of negative emotions, inability to engage in goal-directed behaviors when distressed, difficulties controlling impulsive behaviors when distressed, limited access to emotion regulation strategies perceived as effective, and lack of emotional clarity. Each item is scored from 1 (almost never (0-10%)) to 5 (almost always (91-100%)). Total DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation. Least Squares (LS) mean and standard error were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8 and 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS mean (standard error) for Week 10 are reported.
| units on a scale | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg |
|---|---|---|---|---|---|
| Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at Week 10 | -9.77 ± 1.4 | -9.87 ± 2.1 | -9.76 ± 2.2 | -10.56 ± 2.1 | -8.60 ± 1.5 |
The STAI-S consists of 20 item state anxiety questions that evaluate how respondents feel "right now, at this moment". All items are rated on a weighted score of 1 to 4 scale (e.g. from 'Almost Never to 'Almost Always'); with higher scores indicating greater anxiety. STAI-S score ranges from 20 to 80 where higher scores indicate greater anxiety. Least Squares (LS) mean and standard error were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS mean (standard error) for Week 10 are reported.
| units on a scale | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg |
|---|---|---|---|---|---|
| Change From Baseline in State-Trait Anxiety Inventory (STAI-S) Total Score at Week 10 | -6.64 ± 1.2 | -8.71 ± 1.9 | -5.43 ± 2.0 | -7.00 ± 1.8 | -5.49 ± 1.3 |
The PHQ-9 is a 9-item brief self-reported tool used for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 has a maximum total score of 27. Depression Severity is assessed as: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), or severe (20-27). Least Squares (LS) mean and standard error were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS mean (standard error) for Week 10 are reported.
| units on a scale | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg |
|---|---|---|---|---|---|
| Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Week 10 | -1.30 ± 0.6 | -3.13 ± 0.9 | -1.07 ± 0.9 | -1.57 ± 0.9 | -1.43 ± 0.6 |
The CGI-S rating scale measures the clinician's impression of the severity of illness exhibited by a participant. The CGI-S only question states "Considering your total clinical experience with this particular population, please choose the response below that best describes how mentally ill the patient was over the past week?", and is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Least Squares (LS) mean and standard error were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS mean (standard error) for Week 10 are reported.
| units on a scale | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg |
|---|---|---|---|---|---|
| Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10 | -1.23 ± 0.1 | -1.29 ± 0.2 | -1.47 ± 0.2 | -1.24 ± 0.2 | -1.42 ± 0.1 |
The PGI-S measures the patient's impression of the severity of their illness. It is a single item 5-point scale that asks patients to rate the severity of their illness. The PGI-S question states "Please choose the response below that best describes the overall severity of your symptoms of Borderline Personality Disorder at this time. (Select one response)": 1=No symptoms; 2=Mild; 3=Moderate; 4=Severe; 5=Very severe. Least Squares (LS) mean and standard error were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8,10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS means (standard error) for Week 10 are reported.
| units on a scale | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg |
|---|---|---|---|---|---|
| Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10 | -0.61 ± 0.1 | -0.73 ± 0.1 | -0.73 ± 0.2 | -0.64 ± 0.1 | -0.69 ± 0.1 |
Collected over From first dose of study drug administration until the last dose of study drug administration + 4 weeks of residual effect period, up to 17 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/128 (0%) | 11/128 (8.6%) | 75/128 (58.6%) |
| BI 1358894 5mg | 0/52 (0%) | 4/52 (7.7%) | 32/52 (61.5%) |
| BI 1358894 25mg | 0/53 (0%) | 3/53 (5.7%) | 40/53 (75.5%) |
| BI 1358894 75mg | 0/53 (0%) | 4/53 (7.5%) | 34/53 (64.2%) |
| BI 1358894 125mg | 2/104 (1.9%) | 16/104 (15.4%) | 61/104 (58.7%) |
| Event | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg |
|---|---|---|---|---|---|
| Suicidal ideationPsychiatric disorders | 8/128 | 3/52 | 1/53 | 1/53 | 6/104 |
| Suicidal behaviourPsychiatric disorders | 0/128 | 1/52 | 0/53 | 0/53 | 1/104 |
| DysmenorrhoeaReproductive system and breast disorders | 0/128 | 1/52 | 0/53 | 0/53 | 0/104 |
| Abdominal painGastrointestinal disorders | 0/128 | 0/52 | 1/53 | 0/53 | 0/104 |
| Cannabinoid hyperemesis syndromeGastrointestinal disorders | 0/128 | 0/52 | 1/53 | 0/53 | 0/104 |
| NauseaGastrointestinal disorders | 0/128 | 0/52 | 1/53 | 0/53 | 0/104 |
| VomitingGastrointestinal disorders | 0/128 | 0/52 | 1/53 | 0/53 | 0/104 |
| COVID-19Infections and infestations | 0/128 | 0/52 | 0/53 | 1/53 | 0/104 |
| Hepatitis AInfections and infestations | 0/128 | 0/52 | 0/53 | 1/53 | 0/104 |
| PneumoniaInfections and infestations | 0/128 | 0/52 | 0/53 | 1/53 | 0/104 |
| Event | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg |
|---|---|---|---|---|---|
| HeadacheNervous system disorders | 32/128 | 18/52 | 23/53 | 15/53 | 33/104 |
| NauseaGastrointestinal disorders | 17/128 | 5/52 | 5/53 | 2/53 | 7/104 |
| NasopharyngitisInfections and infestations | 10/128 | 3/52 | 3/53 | 7/53 | 9/104 |
| DizzinessNervous system disorders | 9/128 | 6/52 | 5/53 | 7/53 | 8/104 |
| COVID-19Infections and infestations | 16/128 | 3/52 | 1/53 | 6/53 | 7/104 |
| FatigueGeneral disorders | 11/128 | 6/52 | 1/53 | 6/53 | 9/104 |
| AnxietyPsychiatric disorders | 9/128 | 6/52 | 3/53 | 3/53 | 3/104 |
| SomnolenceNervous system disorders | 4/128 | 3/52 | 5/53 | 6/53 | 4/104 |
| InsomniaPsychiatric disorders | 10/128 | 5/52 | 5/53 | 4/53 | 6/104 |
| ConstipationGastrointestinal disorders | 2/128 | 2/52 | 5/53 | 1/53 | 1/104 |
Treated Set (TS) consisted of all patients who were randomised and that received at least one administration of trial medication.
| Age, Continuous(Years) | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg | Total |
|---|---|---|---|---|---|---|
| Mean | 30.4 ± 9.9 | 29.2 ± 9.6 | 31.0 ± 11.1 | 30.6 ± 9.7 | 29.9 ± 11.2 | 30.2 ± 10.3 |
| Sex: Female, Male(Participants) | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg | Total |
|---|---|---|---|---|---|---|
| Female | 107 | 50 | 48 | 48 | 83 | 336 |
| Male | 21 | 2 | 5 | 5 | 21 | 54 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 50 | 17 | 25 | 20 | 34 | 146 |
| Not Hispanic or Latino | 78 | 35 | 28 | 33 | 70 | 244 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 5 | 2 | 1 | 1 | 6 | 15 |
| Asian | 2 | 3 | 2 | 4 | 7 | 18 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 0 | 1 |
| Black or African American | 8 | 3 | 3 | 1 | 4 | 19 |
| White | 112 | 44 | 46 | 46 | 85 | 333 |
| More than one race | 0 | 0 | 1 | 1 | 2 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| ZAN-BPD total score at Baseline(score on a scale) | Placebo | BI 1358894 5mg | BI 1358894 25mg | BI 1358894 75mg | BI 1358894 125mg | Total |
|---|---|---|---|---|---|---|
| Mean | 16.6 ± 5.0 | 15.7 ± 5.4 | 15.8 ± 4.8 | 16.1 ± 4.6 | 16.4 ± 5.2 | 16.3 ± 5.0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Csr
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