Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1) Clinical Trial Results and Information

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-1)

ClinicalTrials.gov processed this data on November 12, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED (See Contacts and Locations)
Verified November 2024 by Boehringer Ingelheim

Sponsor

Boehringer Ingelheim

Information Provided by (Responsible Party)

Boehringer Ingelheim

Clinicaltrials.gov Identifier

NCT04846868
Other Study ID Numbers: 1346-0011
First Submitted: April 13, 2021
First Posted: April 15, 2021
Last Update Posted: November 13, 2024
Last Verified: November 2024
History of Changes

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Study Description

Not Provided

Condition or Disease	Intervention/Treatment
Schizophrenia	Drug: Iclepertin Drug: Placebo

Study Design

Study Type	Interventional
Actual Enrollment	620 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Quadruple
Primary Purpose	Treatment
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-1)
Study Start Date	September 8, 2021
Actual Primary Completion Date	September 17, 2024
Actual Study Completion Date	October 1, 2024

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
Iclepertin arm	Drug: Iclepertin Iclepertin
Placebo arm	Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

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

Ages Eligible for Study	18 Years to 50 Years (Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	atients must be capable of providing signed and dated written informed consent by date of Visit 1 in accordance with ICH Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP) and the local legislation prior to the admission to the trial. 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) with the following clinical features: Outpatient, clinically stable and in the residual (non-acute) phase of their illness. No hospitalization or increase in level of psychiatric care due to worsening of schizophrenia within 12 weeks prior to randomization. Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 at Visit 1, and confirmed at Visit 2. Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties to stay focused, difficulties to remember instructions, what to say or how to get to places, per investigator judgement. Patients maintained on current antipsychotic treatment (minimum 1 and maximum 2 antipsychotics, but clozapine is not allowed) for at least 12 weeks and on current dose for at least 35 days prior to randomization. -- For patients on two antipsychotics, at least one antipsychotic must be within the approved label dose range. The second antipsychotic must not exceed the maximum daily dose per local label. Note: If the total dose is stable, different dosage forms of the same antipsychotic treatment will be considered as one antipsychotic. 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. Maximum daily benzodiazepine load of up to 1 mg lorazepam-equivalent. For any other psychoactive medications, doses cannot exceed the maximum daily dose per local label. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3 (R2)) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the protocol. Such methods should be used throughout the trial, and for a period of at least 35 days after last trial drug intake, and the patient must agree to periodic pregnancy testing during participation in the trial. Have a study partner, defined as any person either private or professional who knows the patient well, has been capable of interacting with the patient on regular basis, and preferably consistent throughout the study. The study partner must interact with the subject a minimum 1 hour per week and, preferably, at least 2 times a week. At least one interaction per week should be in person. The study partner must have educational achievement of minimum 8th grade. Professional study partners (e.g. study nurse, social worker etc.) are allowed if not involved in administration of any of the protocol assessments. Further inclusion criteria apply.
Exclusion Criteria	articipant with current DSM-5 diagnosis other than Schizophrenia, including but not limited to bipolar, schizoaffective, major depressive disorder etc. Mini International Neuropsychiatric Interview (M.I.N.I.) for Psychotic disorders should be used for guidance. Cognitive impairment due to developmental, neurological (e.g., epilepsy, stroke) or other disorders including head trauma, or patients with dementia or epilepsy. Severe movement disorders Leading to cognitive impairment (e.g. Parkinson dementia), or Interfering with the efficacy assessments, or Due to antipsychotic treatment that cannot be controlled with low dose anticholinergic treatment (equal to maximum 1 mg benztropine twice daily). Any suicidal behavior in the past 1-year prior to screening and during the screening period. Suicidal ideation of type 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with plan and intent) in the past 3 months prior to screening and up to and including Visit 2. -- Patients with Suicidal Ideation type 4 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan), within 3 months prior to screening and up to and including Visit 2, can be randomized in the study, if assessed and documented by a licensed mental health professional that there is no immediate risk of suicide. History of moderate or severe substance use disorder (other than caffeine and nicotine), as defined in DSM-5 within the last 12 months prior to informed consent. Positive urine drug screen at Visit 1 based on central lab test. Patients who were treated with any of the following within 6 months prior to randomization: Clozapine Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil) Ketamine or esketamine Electroconvulsive therapy (ECT) or Modified ECT Further exclusion criteria apply.

Contacts and Locations

Sponsors and Collaborators	Boehringer Ingelheim
Locations	Collaborative Neuroscience Network, LLC (CNS) \| Garden Grove, California, United States, 92845 Omega Clinical Trials,LLC \| La Habra, California, United States, 90631 Artemis Institute for Clinical Research, LLC \| San Diego, California, United States, 92103 Velocity Clinical Research-Santa Ana-68902 \| Santa Ana, California, United States, 92704 Institute of Living \| Hartford, Connecticut, United States, 06106 San Marcus Research Clinic, Inc. \| Miami, Florida, United States, 33014 CCM Clinical Research Group, LLC-Miami-68482 \| Miami, Florida, United States, 33133 Atlanta Center \| Atlanta, Georgia, United States, 30331 University at Buffalo, The State University of New York \| Buffalo, New York, United States, 14215 Richmond Behavioral Associates-Staten Island-68636 \| Staten Island, New York, United States, 10314 University of Cincinnati \| Cincinnati, Ohio, United States, 45219 Neuro-Behavioral Clinical Research \| North Canton, Ohio, United States, 44720 PeaceHealth Medical Group \| Eugene, Oregon, United States, 97401 Community Clinical Research, Inc. \| Austin, Texas, United States, 78754 InSite Clinical Research \| DeSoto, Texas, United States, 75115 North Texas Clinical Trials \| Fort Worth, Texas, United States, 76104 Houston Mind and Brain \| Houston, Texas, United States, 77055 Core Clinical Research \| Everett, Washington, United States, 98201 Monash Alfred Psychiatry Research Centre \| Melbourne, Victoria, Australia, 3004 Hospital das Clinicas da Universidade Federal HC-UFMG \| Belo Horizonte,Minas Gerais, Brazil, 31270901 CPN - Centro de Estudos em Neurociências \| Belo Horizonte, Brazil, 30150-270 Hospital Sao Jose \| Criciuma, Brazil, 88811-000 Trial Tech- Tecnologia em pesquisa com medicamentos \| Curitiba, Brazil, 80.240-280 J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria \| Goiania, Brazil, 74093-040 Hospital de Base - Fac Med de Sao Jose do Rio Preto \| Sao Jose do Rio Preto, Brazil, 15090-000 BR Trials \| Sao Paulo, Brazil, 01236-030 University of Calgary \| Calgary, Alberta, Canada, T2N 4Z6 OCT Research ULC \| Kelowna, British Columbia, Canada, V1Y 1Z9 Centre for Addiction and Mental Health (CAMH) \| Toronto, Ontario, Canada, M6J 1H3 The sixth People's Hospital of Hebei Province \| Baoding, China, 71000 Peking University Sixth Hospital \| Beijing, China, 100089 Beijing HuiLongGuan Hospital \| Beijing, China, 100096 Brain hospital of Hunan province \| Changsha, China, 410007 The Affiliated Brain Hospital of Guangzhou Medical University \| Guangzhou, China, 510370 The Affiliated Hospital of Guizhou Medical University \| Guiyang, China, 550004 Shandong Daizhuang Hospital \| Jining, China, 272051 The First Affilliated Hospital Of Kunming of Medical College \| Kunming, China, 650032 The Affilicated Kangning Hospital of Ningbo University \| Ningbo, China, 315201 Shanghai Mental Health Center \| Shanghai, China, 200030 Tongji Hospital, Tongji University \| Shanghai, China, 200065 Wuxi mental health center \| Wuxi, China, 214151 The Second Affiliated Hospital of Xinxiang Medical Univ. \| Xinxiang, China, 453002 Centro de Investigación y Proyectos en neurociencia CIPNA \| Barranquilla, Colombia, 80020 E.S.E Hospital Mental de Antioquia \| Bello, Colombia, 51053 Instituto Colombiano del Sistema Nervioso- Clínica Montserrat \| Bogota, Colombia, 110121 Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS \| Bogotá, Colombia, 111166 Psynapsis Salud Mental S.A. \| Pereira, Colombia, 660003 Zentrum für klinische Forschung Dr. med. I. Schöll GmbH \| Bad Homburg, Germany, 61348 Praxis Dr. Hahn, Berlin \| Berlin, Germany, 13187 Zentralinstitut für seelische Gesundheit \| Mannheim, Germany, 68159 Neurologie und Psychiatrie / Psychotherapie \| Westerstede, Germany, 26655 Eginition Hospital \| Athens, Greece, 11528 "Attikon" University General Hospital of Attica \| Chaidari, Greece, 12462 Psychiatric Hospital of Attica \| Haidari, Greece, 12462 AX Mental Health Clinic \| Heraclion, Greece, 71305 General Oncology Hospital "Agioi Anargyri" \| Nea Kifisia, Greece, 14564 University General Hospital of Thessaloniki AHEPA \| Thessaloniki, Greece, 54636 General Hospital of Thessaloniki "G. Papanikolaou" \| Thessaloniki, Greece, 57 010 ASST degli Spedali Civili di Brescia \| Brescia, Italy, 25123 A.O. Fatebenefratelli \| Milano, Italy, 20121 Ist. San Raffaele Turro \| Milano, Italy, 20127 Azienda Sanitaria Ospedale S. Luigi Gonzaga \| Orbassano (to), Italy, 10043 A.O.U. Senese Policlinico Santa Maria alle Scotte \| Siena, Italy, 53100 Hotei Hospital \| Aichi, Konan, Japan, 483-8248 National Center for Global Health and Medicine Kohnodai Hospital \| Chiba, Ichikawa, Japan, 272-8516 Mental Clinic Sakurazaka \| Fukuoka, Fukuoka, Japan, 810-0023 Fukuoka University Hospital \| Fukuoka, Fukuoka, Japan, 814-0180 Kuramitsu Hospital \| Fukuoka, Fukuoka, Japan, 819-0037 Shiranui Hospital \| Fukuoka, Omuta, Japan, 836-0004 Obihiro-Kosei General Hospital \| Hokkaido, Obihiro, Japan, 080-0024 Hokkaido University Hospital \| Hokkaido, Sapporo, Japan, 060-8648 St. Marianna University Hospital \| Kanagawa, Kawasaki, Japan, 216-8511 Kitasato University Hospital \| Kanagawa, Sagamihara, Japan, 252-0375 Yokohama Onoecho Clinic \| Kanagawa, Yokohama, Japan, 231-0015 Hino Hospital \| Kanagawa, Yokohama, Japan, 234-0051 Kochi Health Sciences Center \| Kochi, Kochi, Japan, 781-8555 National Hospital Organization Maizuru Medical Center \| Kyoto, Maizuru, Japan, 625-8502 Tohoku University Hospital \| Miyagi, Sendai, Japan, 980-8574 Shounan Hospital \| Nagano, Matsumoto, Japan, 390-0847 Niigata University Medical and Dental Hospital \| Niigata, Niigata, Japan, 951-8520 National Hospital Organization Hizen Psychiatric Medical Center \| Saga, Kanzaki-gun, Japan, 842-0192 Saitama Medical University Hospital \| Saitama, Iruma-gun, Japan, 350-0495 Nishi Kumagaya Hospital \| Saitama, Kumagaya, Japan, 360-0816 Sho Midori Hospital \| Saitama, Saitama, Japan, 336-0022 Dokkyo Medical University Hospital \| Tochigi, Shimotsuga-gun, Japan, 321-0293 Tokushima University Hospital \| Tokushima, Tokushima, Japan, 770-8503 National Center of Neurology and Psychiatry \| Tokyo, Kodaira, Japan, 187-8851 Asuka Hospital \| Tokyo, Machida, Japan, 194-0005 Showa University Karasuyama Hospital \| Tokyo, Setagaya, Japan, 157-8577 Shinjuku East Mental Clinic \| Tokyo, Shinjuku-ku, Japan, 160-0022 Ohwa Mental Clinic \| Tokyo, Toshima-ku, Japan, 170-0002 Yamaguchi University Hospital \| Yamaguchi, Ube, Japan, 755-8505 University of Yamanashi Hospital \| Yamanashi, Chuo, Japan, 409-3898 GabiPros S.C. \| Cdmx, Mexico, 07810 Instituto Nacional de Neurologia y Neurocirugia \| Ciudad de Mexico, Mexico, 14269 Clinica Cemelli \| Guadalajara, Mexico, 44660 Medical Care & Research SA de CV \| Merida, Mexico, 97070 CIT-Neuropsique S.C \| Monterrey, Mexico, 64610 Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME). \| Monterrey, Mexico, 64710 North Shore Hospital, Takapuna \| Takpuna Auckland, New Zealand, 0622 Sykehuset Østfold HF, avd. Moss \| Moss, Norway, N-1535 Akershus Universitetssykehus HF \| Oslo, Norway, N-0963 St. Paul's Hospital-Iloilo City-40765 \| Iloilo City, Philippines, 5000 Philippine General Hospital \| Manila, Philippines, Philippines, 1000 Podlassian Center of Psychogeriatry, Bialystok \| Bialystok, Poland, 15-756 Central Teaching Hospital of the Medical University of Lodz \| Lodz, Poland, 92-216 Individual Specialist Medical Practice Filip Rybakowski \| Poznan, Poland, 60-744 Institute of Psychiatry and Neurology in Warsaw \| Warsaw, Poland, 02-957 Clinhouse \| Zabrze, Poland, 41-807 Psykiatriska Kliniken \| Helsingborg, Sweden, 201 53 Akademiska sjukhuset \| Uppsala, Sweden, 751 85 Hacettepe Universitesi Tip Fakultesi \| Ankara, Turkey, 06230 Ankara University Medical School \| Ankara, Turkey, 06590 Istanbul University \| Istanbul, Turkey, 34093 Dokuz Eylul Universitesi Psikiyatri A.B.D. \| Izmir, Turkey, 35340 Celal Bayar Universitesi Tip Fakultesi \| Manisa, Turkey, 45030