Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia

Completed · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia

In brief

The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after repeated oral dosing to patients with schizophrenia.

Key facts

Study ID

NCT02202226

Run by

H. Lundbeck A/S

People needed

96

Starts

2013-01-01

Last updated by the study team

2015-03-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women between 18 and 60 years (extremes included)
• BMI of ≤38
• 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 screening and baseline
• PANSS total score ≤80
• Score ≤4 (moderate) on the following PANSS items at screening and safety baseline: P7 (hostility), G8 (uncooperativeness)
• Willing to be hospitalised for 4 to 5 weeks after the Safety Baseline Visit

You may not qualify if…

• The patient experienced an acute exacerbation requiring hospitalization within the last 6 months
• The patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks
• The patient has a diagnosis or history of substance dependence (except nicotine) or substance abuse according to DSM-IV-TR® criteria ≤3 months prior to screening
• The patient smokes >20 cigarettes per day
• Other protocol-defined inclusion and exclusion criteria may apply

Where it is running

• PAREXEL Phase I Unit — Glendale, California, United States

Full record on ClinicalTrials.gov

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