Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04846881
• Collaborator: (none)
• Enrollment: 586
• Locations: 83
• Arms: 2
• Anticipated Duration (Months): 34.9
• Patients Per Site: 7.1
• 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. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also 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-blinded, 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-2)
• Actual Study Start Date: Jun 7, 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	CiTrials	Bellflower	California	United States	90706
2	ATP Clinical Research, Inc.	Costa Mesa	California	United States	92626
3	ASCLEPES Research Centers, P.C. dba Alliance Research	Long Beach	California	United States	90807
4	Collaborative Neuroscience Research	Torrance	California	United States	90502
5	Connecticut Mental Health Center	New Haven	Connecticut	United States	06519
6	Research in Miami Inc	Hialeah	Florida	United States	33013
7	Innovative Clinical Research	Lauderhill	Florida	United States	33319
8	Optimus U Corporation	Miami	Florida	United States	33125
9	Altea Research Institute	Las Vegas	Nevada	United States	89102
10	Neurobehavioral Research, Inc.	Cedarhurst	New York	United States	11516
11	New York State Psychiatric Institute	New York	New York	United States	10032
12	Relaro Medical Trials	Dallas	Texas	United States	75243
13	Salem VA Medical Center	Salem	Virginia	United States	24153
14	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
15	CENYDET-Centro Neurobiológico y de Estres Traumático (Biopsychomedical Research Group S.R.L.)	Caba		Argentina	1058AAJ
16	SERES Neurociencia Cognitiva Aplicada	Caba		Argentina	1111
17	Fundación FunDaMos para la asistencia e investigación en psiquiatría	Caba		Argentina	C1405BOA
18	CEN (Centro Especializado Neurociencias)	Cordoba		Argentina	5004
19	Sanatorio Morra S.A.	Córdoba		Argentina	X5009
20	Clinica Privada de Salud Mental Santa Teresa de Avila	La Plata		Argentina	1900
21	Resolution Psychopharmacology Research Institute	Mendoza		Argentina	5502
22	Centro de Investigacion y Asistencia en Psiquiatria (CIAP)	Rosario		Argentina	S2000QJI
23	Ruschel Medicina e Pesquisa Clínica	Rio de Janeiro		Brazil	22270-060
24	Clínica Viver - Centro de Desospitalização Humana	Sao Paulo		Brazil	04020-060
25	Hospital das Clinicas da FMUSP	Sao Paulo		Brazil	05403-010
26	CEMEC - Centro Multidisciplinar de Estudos Clínicos	São Bernardo do Campo		Brazil	09780-000
27	Cpquali Pesquisa Clinica Ltda	São Paulo		Brazil	01228-000
28	Biomedica Research Group	Santiago		Chile	7500710
29	Psicomed Estudios Clínicos	Segunda Región		Chile	1270244
30	Polyclinic Neuron	Zagreb		Croatia	10000
31	Psychiatric Hospital 'Sveti Ivan'	Zagreb		Croatia	10090
32	University Psychiatric Hospital Vrapce	Zagreb		Croatia	10090
33	HOP Charles Perrens	Bordeaux		France	33076
34	HOP la Colombière	Montpellier		France	34295
35	HOP Hôtel-Dieu	Nantes		France	44093
36	HOP Carémeau	Nîmes		France	30029
37	HOP Nord	Saint Priest en Jarez		France	42270
38	University Debrecen Hospital	Debrecen		Hungary	4032
39	PsychoTech Ltd.	Pecs		Hungary	7633
40	Okehazama Hospital Fujita Kokoro Care Center	Aichi, Toyoake		Japan	470-1168
41	Toyota Memorial Hospital	Aichi, Toyota		Japan	471-8513
42	National Hospital Organization Shimofusa Psychiatric Medical Center	Chiba, Chiba		Japan	266-0007
43	Uematsu Mental Clinic	Fukuoka, Chikugo		Japan	833-0041
44	Hirota Clinic	Fukuoka, Kurume		Japan	830-0033
45	Kishi Hospital	Gumma, Kiryu		Japan	376-0011
46	Hokudai-dori Mental Health Clinic	Hokkaido, Sapporo		Japan	001-0010
47	Tatsuta Clinic	Hyogo, Kobe		Japan	651-0097
48	Kanazawa Medical University Hospital	Ishikwa, Kahoku-gun		Japan	920-0293
49	Kishiro Mental Clinic	Kanagawa, Kawasaki		Japan	214-0014
50	Yokohama City University Hospital	Kanagawa, Yokohama		Japan	236-0004
51	Yuge Neuropsychiatric Hospital	Kumamoto, Kumamoto		Japan	861-8002
52	Medical Corporation Yamadakai Yatsushiro Welfare Hospital	Kumamoto, Yatsushiro		Japan	866-0043
53	National Hospital Organization Sakakibara Hospital	Mie, Tsu		Japan	514-1292
54	Shironishi Hospital	Nagano, Matsumoto		Japan	390-8648
55	Suwa Red Cross Hospital	Nagano, Suwa		Japan	392-8510
56	Nara Medical University Hospital	Nara, Kashihara		Japan	634-8522
57	Arakaki Hospital	Okinawa, Okinawa		Japan	904-0012
58	Osaka City Hospital Organization Osaka City General Hospital	Osaka, Osaka		Japan	534-0021
59	Rainbow and Sea Hospital	Saga, Karatsu		Japan	847-0031
60	Inuo Hospital	Saga, Tosu		Japan	841-0081
61	Medical Corporation Seijin Hospital	Tokyo, Adachi-ku		Japan	121-8515
62	Tokyo Medical and Dental University Hospital	Tokyo, Bunkyo-ku		Japan	113-8519
63	Murakami Hospital	Tokyo, Edogawa-ku		Japan	133-0073
64	Nishigahara Hospital	Tokyo, Kita-ku		Japan	114-0024
65	Minami-Aoyama Antique Street Clinic	Tokyo, Minato-ku		Japan	107-0062
66	Maynds Tower Mental Clinic	Tokyo, Shibuya-ku		Japan	151-0053
67	Hokuriku Hospital	Toyama, Nanto		Japan	939-1893
68	Inje University Haeundae Paik Hospital	Busan		Korea, Republic of	612-896
69	Chonbuk National University Hospital	Jeonju		Korea, Republic of	54907
70	Seoul National University Hospital	Seoul		Korea, Republic of	03080
71	Universitair Medisch Centrum Groningen	Groningen		Netherlands	9713 AV
72	Kien VIP	Leeuwarden		Netherlands	8911 KJ
73	Maastricht University	Maastricht		Netherlands	6229 HX
74	EUROMEDIS Sp. z o.o., Szczecin	Szczecin		Poland	70-111
75	Institute of Mental Health	Belgrade		Serbia	11000
76	EPAMED s.r.o.	Kosice		Slovakia	040 01
77	Psychiatricka Ambulancia Psycholine s.r.o.	Rimavska Sobota		Slovakia	97901
78	Hospital Puerta de Hierro	Majadahonda		Spain	28222
79	Centro de Salud de San Juan	Salamanca		Spain	37005
80	Benito Menni Complejo Asistencial en Salud Mental	Sant Boi de Llobregat		Spain	08830
81	Hospital Clínico de Valencia	Valencia		Spain	46010
82	Hospital Provincial. Complejo Asistencial de Zamora	Zamora		Spain	49021
83	Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council	Nove		Ukraine	25491

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: NCT04846881
• Other Study ID Numbers: 1346-0012; 2020-003744-84
• 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