Clinical trial NCT04860830: CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 609
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) consensus cognitive battery (MCCB)
timeFrame: After 26 weeks of treatment
Secondary outcomes:
measure: Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score
timeFrame: After 26 weeks of treatment
measure: Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
timeFrame: Up to week 26
measure: Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London
timeFrame: Up to week 26
measure: Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score
timeFrame: Up to week 24
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Pico Rivera
country: United States
facility: CNRI - Los Angeles
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Walnut Creek
country: United States
facility: Sunwise Clinical Research-Walnut Creek-70166
state: California
city: Hollywood
country: United States
facility: Advanced Medical Research Group Inc
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites Network
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group, LLC
state: Florida
city: Orlando
country: United States
facility: Nova Psychiatry Inc.
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research-Atlanta-67262
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Gaithersburg
country: United States
facility: Center for Behavioral Health, LLC
state: Maryland
city: Saint Louis
country: United States
facility: Arch Clinical Trials, LLC
state: Missouri
city: Omaha
country: United States
facility: Omaha Insomnia and Psychiatric Services
state: Nebraska
city: Berlin
country: United States
facility: Hassman Research Institute-Berlin-60540
state: New Jersey
city: Raleigh
country: United States
facility: UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Rivus Wellness and Research Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: State College
country: United States
facility: Oasis Life Care
state: Pennsylvania
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: Richmond
country: United States
facility: LinQ Research, LLC-Richmond-70076
state: Texas
city: Banfield
country: Argentina
facility: Clínica Privada Banfield
city: Caba
country: Argentina
facility: Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
city: Caba
country: Argentina
facility: Fundación FunDaMos para la asistencia e investigación en psiquiatría
city: Cordoba
country: Argentina
facility: CEN (Centro Especializado Neurociencias)
city: Cordoba
country: Argentina
facility: Instituto Médico DAMIC S.R.L.
city: Córdoba
country: Argentina
facility: Instituto Modelo de Neurología Lennox
city: La Plata
country: Argentina
facility: Instituto de Neurociencias San Agustín
city: Rosario
country: Argentina
facility: Instituto Médico de la Fundación Estudios Clínicos
city: San Vicente
country: Argentina
facility: Centro Medico Luquez
city: Vienna
country: Austria
facility: AKH - Medical University of Vienna
city: Bertix
country: Belgium
facility: CUP Vivalia -La Clairière
city: Bierbeek
country: Belgium
facility: Sint-Kamillus
city: Duffel
country: Belgium
facility: Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
city: Mechelen
country: Belgium
facility: Meclinas
city: Rio de Janeiro
country: Brazil
facility: Ruschel Medicina e Pesquisa Clínica
city: Sao Paulo
country: Brazil
facility: Clínica Viver - Centro de Desospitalização Humana
city: Plovdiv
country: Bulgaria
facility: Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry
city: Plovdiv
country: Bulgaria
facility: Medical Center "Spectar"
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Beijing
country: China
facility: Beijing Anding Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital Of Central South University
city: Guangzhou
country: China
facility: The third affiliated hospital of Sun Yat-Sen University
city: Huzhou
country: China
facility: Huzhou Third Municipal Hospital
city: Nanjing
country: China
facility: Nanjing Brain Hospital
city: Shenzhen
country: China
facility: Shenzhen Kangning Hospital
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
city: Tianjin
country: China
facility: Tianjin Anding Hospital
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an JiaoTong University
city: Xi'an
country: China
facility: Xi'an Mental Health Center
city: Zhumadian
country: China
facility: Zhumadian Psychiatric Hospital
city: Klecany
country: Czechia
facility: National Institute of Mental Health
city: Ostrava
country: Czechia
facility: MP Meditrine s.r.o.
city: Plzen
country: Czechia
facility: A-SHINE s.r.o
city: Prague
country: Czechia
facility: PRAGTIS s.r.o.
city: Prague
country: Czechia
facility: INEP medical s.r.o.
city: Ricany
country: Czechia
facility: Psychiatrie Ricany s.r.o.
city: Aalborg
country: Denmark
facility: Aalborg Universitetsshospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Glostrup
country: Denmark
facility: Psykiatrisk Center Glostrup
city: Espoo
country: Finland
facility: HUS Jorvi Hospital
city: Helsinki
country: Finland
facility: Aurora hospital
city: Turku
country: Finland
facility: CRST - Clinical Research Services Turku
city: Böblingen
country: Germany
facility: Studienzentrum für Neurologie und Psychiatrie
city: Dortmund
country: Germany
facility: LWL-Klinik Dortmund
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: München
country: Germany
facility: Klinikum der Universität München - Campus Innenstadt
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Kaunas
country: Lithuania
facility: JSC Romuvos Clinic
city: Kaunas
country: Lithuania
facility: LUHS KH Psichiatric Clinic Mariu Division
city: Silute
country: Lithuania
facility: JSC Medical center "Puriena"
city: Vilnius
country: Lithuania
facility: Vilnius City Mental Health Center
city: Chihuahua
country: Mexico
facility: Centro de Investigacion Integral MEDIVEST S.C
city: Ciudad de Mexico
country: Mexico
facility: Centro de Investigación Clinica Acelerada, S.C.
city: Culiacan
country: Mexico
facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
city: Leon
country: Mexico
facility: Hospital Aranda de la Parra
city: Monterrey
country: Mexico
facility: Iecsi S.C.
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: San Luis Potosi
country: Mexico
facility: BIND Investigaciones S.C.
city: Leiria
country: Portugal
facility: ULS da Região de Leiria, E.P.E.
city: Lisboa
country: Portugal
facility: ULS de Santa Maria, E.P.E
city: Loures
country: Portugal
facility: ULS de Loures-Odivelas, E.P.E
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dr. Dragisa Misovic
city: Belgrade
country: Serbia
facility: General Hospital Euromedik
city: Gornja Toponica
country: Serbia
facility: Special Hospital for Psychiatric Diseases Gornja Toponica
city: Kaohsiung
country: Taiwan
facility: Kai-Syuan Psychiatric Hospital
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital Keelung
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Tainan
country: Taiwan
facility: NCKUH
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital(Linkou)
city: Taoyuan
country: Taiwan
facility: Taoyuan Psychiatric Center
city: Bodmin
country: United Kingdom
facility: Bodmin Community Hospital
city: Cheltenham
country: United Kingdom
facility: The Fritchie Centre
city: Chester
country: United Kingdom
facility: Redesmere
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: London
country: United Kingdom
facility: Maudsley Hospital
city: Oxford
country: United Kingdom
facility: Warneford Hospital
city: Southampton
country: United Kingdom
facility: Moorgreen Hospital
Study officials:
References: