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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04566601




Registration number
NCT04566601
Ethics application status
Date submitted
23/09/2020
Date registered
28/09/2020

Titles & IDs
Public title
A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder
Scientific title
A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 1358894 Once Daily Over 12 Week Treatment Period in Patients With Borderline Personality Disorder
Secondary ID [1] 0 0
2020-000078-12
Secondary ID [2] 0 0
1402-0012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 1358894
Treatment: Drugs - Placebo

Experimental: BI 1358894 5mg -

Experimental: BI 1358894 25mg -

Experimental: BI 1358894 75mg -

Experimental: BI 1358894 125mg -

Placebo comparator: Placebo -


Treatment: Drugs: BI 1358894
Film-coated tablet

Treatment: Drugs: Placebo
Film-coated tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10
Timepoint [1] 0 0
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.
Secondary outcome [1] 0 0
ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Response: Defined as =30% ZAN-BPD Reduction From Baseline at Week 10
Timepoint [1] 0 0
Baseline and at Week 10.
Secondary outcome [2] 0 0
Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at Week 10
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Change From Baseline in State-Trait Anxiety Inventory (STAI-S) Total Score at Week 10
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Week 10
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10
Timepoint [6] 0 0
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.

Eligibility
Key inclusion criteria
* Patients meeting diagnostic criteria of borderline personality disorder (BoPD) per Diagnostic and Statistical Manual of Mental Disorders(DSM-5) at screening visit, confirmed by Structured Interview for DSM-5 Personality Disorder (SCID-5-PD).
* Zanarini rating scale for Borderline personality disorder (ZAN-BPD) of = 9 at screening (Visit 1) and randomization (Visit 2), with question #2 Affective Instability score of =2.
* Male or female patients, 18-65 years of age at the time of consent
* 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.
* Signed and dated written informed consent in accordance with International Council on Harmonization (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
* further inclusion criteria apply.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current diagnosis of paranoid, schizoid, schizotypal and antisocial personality disorders, as confirmed by SCID-5-PD at screening visit.
* Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, or delusional disorder as confirmed by the SCID-5 at the screening visit.
* Any other mental disorder that is the primary focus of treatment in the last 6 months prior to randomization, as per the clinical judgement of the investigator.
* Inpatient stay or hospitalization due to worsening of BoPD within 3 months prior to randomization.
* Initiation or change in any type or frequency of psychotherapy for BoPD within the last 3 months prior to screening.
* Any ongoing use of psychotropic medications within 7 days prior to randomization or during the course of study.
* Any suicidal behavior in the past 1 year.
* Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months.
* further exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/01/2023
Sample size
Target
Accrual to date
Final
390
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peninsula Therapeutic and Research Group - Frankston
Recruitment hospital [2] 0 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Argentina
State/province [12] 0 0
Caba
Country [13] 0 0
Argentina
State/province [13] 0 0
Cordoba
Country [14] 0 0
Argentina
State/province [14] 0 0
Córdoba
Country [15] 0 0
Argentina
State/province [15] 0 0
La Plata
Country [16] 0 0
Argentina
State/province [16] 0 0
Rosario
Country [17] 0 0
Belgium
State/province [17] 0 0
Duffel
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Plovdiv
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
Czechia
State/province [20] 0 0
Ostrava-Poruba
Country [21] 0 0
Czechia
State/province [21] 0 0
Prague
Country [22] 0 0
Denmark
State/province [22] 0 0
Aalborg
Country [23] 0 0
Denmark
State/province [23] 0 0
Slagelse
Country [24] 0 0
France
State/province [24] 0 0
Bron
Country [25] 0 0
France
State/province [25] 0 0
Montpellier
Country [26] 0 0
Germany
State/province [26] 0 0
Aachen
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Bonn
Country [29] 0 0
Germany
State/province [29] 0 0
Gießen
Country [30] 0 0
Germany
State/province [30] 0 0
Mannheim
Country [31] 0 0
Germany
State/province [31] 0 0
München
Country [32] 0 0
Germany
State/province [32] 0 0
Tübingen
Country [33] 0 0
Italy
State/province [33] 0 0
Brescia
Country [34] 0 0
Japan
State/province [34] 0 0
Fukuoka, Fukuoka
Country [35] 0 0
Japan
State/province [35] 0 0
Fukuoka, Kurume
Country [36] 0 0
Japan
State/province [36] 0 0
Kanagawa, Kawasaki
Country [37] 0 0
Japan
State/province [37] 0 0
Kanagawa, Yokohama
Country [38] 0 0
Japan
State/province [38] 0 0
Nara, Kashihara
Country [39] 0 0
Japan
State/province [39] 0 0
Tokyo, Chuo-ku
Country [40] 0 0
Japan
State/province [40] 0 0
Tokyo, Shinjuku-ku
Country [41] 0 0
Mexico
State/province [41] 0 0
Cdmx
Country [42] 0 0
Mexico
State/province [42] 0 0
Merida
Country [43] 0 0
Mexico
State/province [43] 0 0
Monterrey
Country [44] 0 0
Mexico
State/province [44] 0 0
Queretaro
Country [45] 0 0
Mexico
State/province [45] 0 0
San Luis Potosi
Country [46] 0 0
Poland
State/province [46] 0 0
Bialystok
Country [47] 0 0
Poland
State/province [47] 0 0
Gdansk
Country [48] 0 0
Spain
State/province [48] 0 0
Santander
Country [49] 0 0
Spain
State/province [49] 0 0
Sevilla
Country [50] 0 0
Spain
State/province [50] 0 0
Valladolid
Country [51] 0 0
Sweden
State/province [51] 0 0
Enskede
Country [52] 0 0
Sweden
State/province [52] 0 0
Göteborg
Country [53] 0 0
Sweden
State/province [53] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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'.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04566601