CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Phase III Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of Iclepertin Once Daily Over 26 Week Treatment Period in Patients With Schizophrenia (CONNEX-3)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04860830
• Other study ID #: 1346-0013
• Secondary ID: 2020-003726-23
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 18, 2021
• Est. completion date: November 22, 2024

Study information

• Verified date: June 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 iclepertin improves learning and memory in people with schizophrenia.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 609
• Est. completion date: November 22, 2024
• Est. primary completion date: October 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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 or epilepsy.

• 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• iclepertin
iclepertin
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	Clínica Privada Banfield	Banfield
Argentina	Fundación FunDaMos para la asistencia e investigación en psiquiatría	Caba
Argentina	Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)	Caba
Argentina	CEN (Centro Especializado Neurociencias)	Cordoba
Argentina	Instituto Médico DAMIC S.R.L.	Cordoba
Argentina	Instituto Modelo de Neurología Lennox	Córdoba
Argentina	Instituto de Neurociencias San Agustín	La Plata
Argentina	Instituto Médico de la Fundación Estudios Clínicos	Rosario
Argentina	Centro Medico Luquez	San Vicente
Austria	AKH - Medical University of Vienna	Vienna
Belgium	CUP Vivalia -La Clairière	Bertix
Belgium	Sint-Kamillus	Bierbeek
Belgium	Universitair Psychiatrisch Centrum Duffel (UPC Duffel)	Duffel
Belgium	Meclinas	Mechelen
Brazil	Ruschel Medicina e Pesquisa Clínica	Rio de Janeiro
Brazil	Pesquisare	Santo André
Brazil	Clínica Viver - Centro de Desospitalização Humana	Sao Paulo
Bulgaria	"Filipopolis" - Ambulatory for Group Practice for Specialized Care in Psychiatry	Plovdiv
Bulgaria	Medical Center "Spectar"	Plovdiv
Bulgaria	Medical Center Hera EOOD	Sofia
China	Beijing Anding Hospital	Beijing
China	The Second Xiangya Hospital Of Central South University	Changsha
China	3rd Affiliated Hosp of Sun yet-sen University	Guangzhou
China	Huzhou Third Municipal Hospital	Huzhou
China	Brain Hospital Affiliated to Nanjing Med University	Nanjing
China	Shenzhen Kangning Hospital	Shenzhen
China	The First Hospital of Hebei Medical University	Shijiazhuang
China	Tianjin Anding Hospital	Tianjin
China	First Affiliated Hospital of Xi'an JiaoTong University	Xi'an
China	Xi'an Mental Health Center	Xi'an
China	Zhumadian Psychiatric Hospital	Zhumadian
Czechia	National Institute of Mental Health	Klecany
Czechia	MPMeditrine s.r.o.	Ostrava-Poruba
Czechia	A-SHINE s.r.o	Plzen
Czechia	INEP medical s.r.o.	Prague
Czechia	PRAGTIS s.r.o.	Prague
Czechia	Psychiatrie Ricany s.r.o.	Ricany
Denmark	Aalborg Universitetsshospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Psykiatrisk Center Glostrup	Glostrup
Finland	HUS Jorvi Hospital	Espoo
Finland	Aurora hospital	Helsinki
Finland	CRST - Clinical Research Services Turku	Turku
Germany	Studienzentrum für Neurologie und Psychiatrie	Böblingen
Germany	LWL-Klinik Dortmund	Dortmund
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Klinikum der Universität München - Campus Innenstadt	München
Germany	Universitätsklinikum Tübingen	Tübingen
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	CHA Bundang Medical Center	Seongnam
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan
Lithuania	JSC Romuvos Clinic	Kaunas
Lithuania	LUHS KH Psichiatric Clinic Mariu Division	Kaunas
Lithuania	JSC Medical center "Puriena"	Silute
Lithuania	Vilnius City Mental Health Center	Vilnius
Mexico	Centro de Investigacion Integral MEDIVEST S.C	Chihuahua
Mexico	Centro de Investigación Clinica Acelerada, S.C.	Ciudad de Mexico
Mexico	Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.	Culiacan
Mexico	Hospital Aranda de la Parra	Leon
Mexico	Hospital Universitario Dr Jose Eleuterio Gonzalez	Monterrey
Mexico	Iecsi S.C.	Monterrey
Mexico	BIND Investigaciones S.C.	San Luis Potosi
Portugal	ULS da Região de Leiria, E.P.E.	Leiria
Portugal	ULS de Santa Maria, E.P.E	Lisboa
Portugal	ULS de Loures-Odivelas, E.P.E	Loures
Serbia	Clinical Hospital Center Dr. Dragisa Misovic	Belgrade
Serbia	General Hospital Euromedik	Belgrade
Serbia	Special Hospital for Psychiatric Diseases Gornja Toponica	Gornja Toponica
Taiwan	Kai-Syuan Psychiatric Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital Keelung	Keelung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	NCKUH	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Taoyuan Psychiatric Center	Taoyuan
Taiwan	Chang Gung Memorial Hospital(Linkou)	Taoyuan County
United Kingdom	Bodmin Community Hospital	Bodmin
United Kingdom	The Fritchie Centre	Cheltenham
United Kingdom	Redesmere	Chester
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Maudsley Hospital	London
United Kingdom	Warneford Hospital	Oxford
United Kingdom	Moorgreen Hospital	Southampton
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Synexus Clinical Research	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	Hassman Research Institute	Berlin	New Jersey
United States	ProScience Research Group	Culver City	California
United States	Midwest Clinical Research	Dayton	Ohio
United States	Center for Behavioral Health, LLC	Gaithersburg	Maryland
United States	Advanced Medical Research Group Inc	Hollywood	Florida
United States	Ben Taub General Hospital	Houston	Texas
United States	Sunwise Clinical Research	Lafayette	California
United States	University of California Los Angeles	Los Angeles	California
United States	Accel Research Sites Network	Maitland	Florida
United States	Ivetmar Medical Group, LLC	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	Rivus Wellness and Research Institute	Oklahoma City	Oklahoma
United States	Omaha Insomnia and Psychiatric Services	Omaha	Nebraska
United States	Nova Psychiatry Inc.	Orlando	Florida
United States	CNRI - Los Angeles	Pico Rivera	California
United States	UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center	Raleigh	North Carolina
United States	Arch Clinical Trials, LLC	Saint Louis	Missouri
United States	Stanford University Medical Center	Stanford	California
United States	Oasis Life Care	State College	Pennsylvania
United States	LinQ Research, LLC	Sugar Land	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Bulgaria,  China,  Czechia,  Denmark,  Finland,  Germany,  Korea, Republic of,  Lithuania,  Mexico,  Portugal,  Serbia,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) consensus cognitive battery (MCCB)	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	After 26 weeks of treatment
Secondary	Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score	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.	After 26 weeks of treatment
Secondary	Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)		Up to week 26
Secondary	Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London		Up to week 26
Secondary	Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score	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.	Up to week 24

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