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 July 8, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified July 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: July 9, 2024
Last Verified: July 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 TypeInterventional
Actual Enrollment620 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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 DateJune 16, 2021
Anticipated Primary Completion DateSeptember 13, 2024
Anticipated Study Completion DateOctober 11, 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Iclepertin
  • Drug: Iclepertin
    • Iclepertin
  • Placebo
  • Drug: 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 T-score 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

    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, 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, 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, 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
    • Ningbo Kangning Hospital | 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 | Bad Homburg, Germany, 61350
    • 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, Philippines, 5000
    • Makati Medical Center | Makati City, Philippines, 1229
    • 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

    More Information

    Additional Information

    Additional Relevant MeSH Terms

    • Schizophrenia
    • Schizophrenia Spectrum and Other Psychotic Disorders
    • Mental Disorders