NCT01377233

Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia

A Randomised, Double-blind, Parallel-group, Explorative Study of the Safety, Tolerability, and Pharmacokinetics of Daily Dosing Compared to Weekly Dosing of Zicronapine in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.

Detailed description

The study includes 2 treatment periods. The open-label run-in period will begin at patient enrolment and continue for 3 weeks, during which all patients will receive once daily treatment with zicronapine. The double-blind period will begin at patient randomization and continue for 5 weeks, during which the patients will be assigned to one group receiving once daily treatment with zicronapine and 3 groups receiving once weekly treatment with zicronapine.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Zicronapine open-label lead-in 10 mg daily	Encapsulated tablet ,10 mg, once daily, open-label
DRUG	Zicronapine 10 mg daily	Encapsulated tablet, 10 mg, once daily, double-blind
DRUG	Zicronapine 20 mg once weekly	Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
DRUG	Zicronapine 30 mg once weekly	Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
DRUG	Zicronapine 45 mg once weekly	Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-02-01
• First posted: 2011-06-21
• Last updated: 2016-03-22
• Results posted: 2016-03-22

Locations

4 sites across 1 country: United States