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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Lu AF35700; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02202226

14754A

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups, including a placebo group

Lu AF35700 oral solution (1 mg/mL)

Experimental group

Description:

Planned daily doses range from 5 mg/day to 30 mg/day for 3 weeks. Weekly doses up to 75 mg/week for 3 weeks.

Treatment:

Drug: Lu AF35700

Matching placebo

Placebo Comparator group

Description:

Oral solution

Treatment:

Drug: Placebo