Status:
COMPLETED
Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- Other pre-defined inclusion and exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02202213
Start Date
October 1 2013
Last Update
February 18 2015
Active Locations (1)
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1
Parexel International
Glendale, California, United States, 91206