Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04846868
• Collaborator: (none)
• Enrollment: 586
• Locations: 90
• Arms: 2
• Anticipated Duration (Months): 34.6
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.2

Study Details

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 BI 425809 improves learning and memory in people with schizophrenia.

Participants are put into two groups randomly, which means by chance. One group takes BI 425809 tablets and the other group takes placebo tablets. Placebo tablets look like BI 425809 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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: BI 425809; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 586 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase III Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily Over 26 Week Treatment Period in Patients With Schizophrenia (CONNEX-1)
• Actual Study Start Date: Jun 16, 2021
• Anticipated Primary Completion Date: Apr 5, 2024
• Anticipated Study Completion Date: May 3, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 425809	Drug: BI 425809; BI 425809
Placebo Comparator: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) after 26 weeks of treatment [at baseline and at week 26]

   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

1. Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score after 26 weeks of treatment [at baseline and at week 26]

   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.

2. Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) [at baseline and at week 26]

3. Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London (ToL) test [at baseline and at week 26]

4. Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score [up to 24 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Collaborative Neuroscience Network, LLC (CNS)	Garden Grove	California	United States	92845
2	Artemis Institute for Clinical Research, LLC	San Diego	California	United States	92103
3	National Research Institute	Santa Ana	California	United States	92704
4	San Marcus Research Clinic, Inc.	Miami	Florida	United States	33014
5	CCM Clinical Research Group, LLC	Miami	Florida	United States	33133
6	Atlanta Center	Atlanta	Georgia	United States	30331
7	University at Buffalo, The State University of New York	Buffalo	New York	United States	14215
8	Richmond Behavioral Associates	Staten Island	New York	United States	10314
9	Neuro-Behavioral Clinical Research	North Canton	Ohio	United States	44720
10	Community Clinical Research, Inc.	Austin	Texas	United States	78754
11	InSite Clinical Research	DeSoto	Texas	United States	75115
12	North Texas Clinical Trials	Fort Worth	Texas	United States	76104
13	Core Clinical Research	Everett	Washington	United States	98201
14	CPN - Centro de Estudos em Neurociências	Belo Horizonte		Brazil	30150-270
15	Trial Tech- Tecnologia em pesquisa com medicamentos	Curitiba		Brazil	80.240-280
16	J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria	Goiania		Brazil	74093-040
17	Hospital de Base - Fac Med de Sao Jose do Rio Preto	Sao Jose do Rio Preto		Brazil	15090-000
18	BR Trials	Sao Paulo		Brazil	05003090
19	The sixth People's Hospital of Hebei Province	Baoding		China	71000
20	Peking University Sixth Hospital	Beijing		China	100089
21	Beijing HuiLongGuan Hospital	Beijing		China	100096
22	Brain hospital of Hunan province	Changsha		China	410007
23	The Affiliated Brain Hospital of Guangzhou Medical University	Guangzhou		China	510370
24	The Affiliated Hospital of Guizhou Medical University	Guiyang		China	550004
25	Shandong Daizhuang Hospital	Jining		China	272051
26	The First Affilliated Hospital Of Kunming of Medical College	Kunming		China	650032
27	Ningbo Kangning Hospital	Ningbo		China	315201
28	Tongji Hospital, Tongji University	Shanghai		China	200065
29	The Second Affiliated Hospital of Xinxiang Medical Univ.	Xinxiang		China	453002
30	Centro de Investigación y Proyectos en neurociencia CIPNA	Barranquilla		Colombia	80020
31	E.S.E Hospital Mental de Antioquia	Bello		Colombia
32	Instituto Colombiano del Sistema Nervioso- Clínica Montserrat	Bogota		Colombia	110121
33	Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS	Bogotá		Colombia	111166
34	Psynapsis Salud Mental S.A.	Pereira		Colombia	660003
35	Zentrum für klinische Forschung Dr. Schöll, Dr. Steidl & Kollegen	Bad Homburg		Germany	61348
36	Praxis Dr. Hahn, Berlin	Berlin		Germany	13187
37	Zentralinstitut für seelische Gesundheit	Mannheim		Germany	68159
38	Neurologie und Psychiatrie / Psychotherapie	Westerstede		Germany	26655
39	"Attikon" University General Hospital of Attica	Chaidari		Greece	12462
40	Psychiatric Hospital of Attica	Haidari		Greece	12462
41	General Oncology Hospital "Agioi Anargyri"	Nea Kifisia		Greece	14564
42	ASST degli Spedali Civili di Brescia	Brescia		Italy	25123
43	Azienda Sanitaria Ospedale S. Luigi Gonzaga	Orbassano (to)		Italy	10043
44	A.O.U. Senese Policlinico Santa Maria alle Scotte	Siena		Italy	53100
45	Hotei Hospital	Aichi, Konan		Japan	483-8248
46	Aichi Medical University Hospital	Aichi, Nagakute		Japan	480-1195
47	National Center for Global Health and Medicine Kohnodai Hospital	Chiba, Ichikawa		Japan	272-8516
48	Fukuoka University Hospital	Fukuoka, Fukuoka		Japan	814-0180
49	Kuramitsu Hospital	Fukuoka, Fukuoka		Japan	819-0037
50	Shiranui Hospital	Fukuoka, Omuta		Japan	836-0004
51	Obihiro-Kosei General Hospital	Hokkaido, Obihiro		Japan	080-0024
52	Hokkaido University Hospital	Hokkaido, Sapporo		Japan	060-8648
53	St. Marianna University Hospital	Kanagawa, Kawasaki		Japan	216-8511
54	Yokohama Onoecho Clinic	Kanagawa, Yokohama		Japan	231-0015
55	Hino Hospital	Kanagawa, Yokohama		Japan	234-0051
56	Kochi Health Sciences Center	Kochi, Kochi		Japan	781-8555
57	National Hospital Organization Maizuru Medical Center	Kyoto, Maizuru		Japan	625-8502
58	Tohoku University Hospital	Miyagi, Sendai		Japan	980-8574
59	Niigata University Medical and Dental Hospital	Niigata, Niigata		Japan	951-8520
60	National Hospital Organization Hizen Psychiatric Medical Center	Saga, Kanzaki-gun		Japan	842-0192
61	Saitama Medical University Hospital	Saitama, Iruma-gun		Japan	350-0495
62	Nishi Kumagaya Hospital	Saitama, Kumagaya		Japan	360-0816
63	Dokkyo Medical University Hospital	Tochigi, Shimotsuga-gun		Japan	321-0293
64	Tokushima University Hospital	Tokushima, Tokushima		Japan	770-8503
65	Negishi Hospital	Tokyo, Fuchu		Japan	183-0042
66	National Center of Neurology and Psychiatry	Tokyo, Kodaira		Japan	187-8851
67	Asuka Hospital	Tokyo, Machida		Japan	194-0005
68	Showa University Karasuyama Hospital	Tokyo, Setagaya		Japan	157-8577
69	Shinjuku East Mental Clinic	Tokyo, Shinjuku-ku		Japan	160-0022
70	Ohwa Mental Clinic	Tokyo, Toshima-ku		Japan	170-0002
71	Yamaguchi University Hospital	Yamaguchi, Ube		Japan	755-8505
72	University of Yamanashi Hospital	Yamanashi, Chuo		Japan	409-3898
73	GabiPros S.C.	Cdmx		Mexico	07810
74	Instituto Nacional de Neurologia y Neurocirugia	Ciudad de Mexico		Mexico	14269
75	Clinica Cemelli	Guadalajara		Mexico	44100
76	Medical Care & Research SA de CV	Merida		Mexico	97070
77	CIT-Neuropsique S.C	Monterrey		Mexico	64610
78	Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME).	Monterrey		Mexico	64710
79	CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc	México		Mexico	C.P. 11650
80	Sykehuset Østfold HF, avd. Moss	Moss		Norway	N-1535
81	Akershus Universitetssykehus HF	Oslo		Norway	N-0963
82	Podlassian Center of Psychogeriatry, Bialystok	Bialystok		Poland	15-756
83	Central Teaching Hospital of the Medical University of Lodz	Lodz		Poland	92-216
84	Individual Specialist Medical Practice Filip Rybakowski	Poznan		Poland	60-744
85	Institute of Psychiatry and Neurology in Warsaw	Warsaw		Poland	02-957
86	State Medical University, Kazan	Kazan		Russian Federation	420012
87	FSBEI of HE Smolensk State Medical University	Smolensk		Russian Federation	214019
88	SBIH of the Stavropol region "Regional Specialized Psychiatric Hospital No. 2"	Stavropol		Russian Federation	357034
89	Psykiatriska Kliniken	Helsingborg		Sweden	201 53
90	Akademiska sjukhuset	Uppsala		Sweden	751 85

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT04846868
• Other Study ID Numbers: 1346-0011; 2020-003760-11
• First Posted: Apr 15, 2021
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Schizophrenia; BI 425809

Study Results

No Results Posted as of Aug 25, 2022