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Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia | Clinical Trials | Clareo Health

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Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia

Interventional, Randomised, Double-blind, Placebo Controlled, Multiple-dose Study Investigating the Safety, Tolerability, PK and PD Properties of Lu AF11167 in Patients With Schizophrenia

NCT02202213•H. Lundbeck A/S

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and tolerability of Lu AF11167 in patients with schizophrenia following various repeated dosing regimens of Lu AF11167 (alone or as added treatment to risperidone).

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Man or woman aged ≥18 years and ≤60 years with a body mass index (BMI) of ≥18.5 and ≤38 m2
•Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)
•Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at the Screening Visit and Baseline Visit (Day -1)
•PANSS total score ≤80 at the Screening Visit and the Baseline Visit (Day -1)
•Score of 4 (moderate) of the following PANSS items at the Screening Visit and the Baseline Visit (Day -1): P7 (hostility), G8 (uncooperativeness)
•Minimal level of extrapyramidal signs, defined as a score ≤5 (moderately severe) in any of the four Clinical Global Impression of Severity (CGI-S) items of the ESRS-A; parkinsonism, akathisia, dystonia, and tardive dyskinesia at the Screening Visit and the Baseline Visit
•Willingness to be hospitalised for approximately 3 weeks after the Baseline Visit (Day -1)

Exclusion Criteria

•The patient experienced an acute exacerbation requiring hospitalization within the last 6 months
•The patient experienced an acute exacerbation requiring increase in antipsychotic medication (with reference to drug or dose) within the last 4 weeks

Locations (1)

Parexel International

Glendale, California, United States

Key Dates

Start Date

October 1, 2013

Primary Completion Date

February 1, 2015

Last Updated

February 18, 2015

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

Placebo

DRUG

Lu AF11167

DRUG

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NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia

Inclusion Criteria

Exclusion Criteria

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