CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Zicronapine open-label lead-in 10 mg daily +4 moredrug
Likely dose
Zicronapine open-label lead-in 10 mg dailyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01377233
NCT01377233Phase 2Completed
CompareCT.gov

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

H. Lundbeck A/S·interventional·Posted Jun 21, 2011·Updated Mar 22, 2016

In Brief

A Phase 2 clinical trial evaluating Zicronapine open-label lead-in 10 mg daily, Zicronapine 10 mg daily, and 3 other interventions for Schizophrenia. Completed, enrolled 46 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 21, 2011
Enrollment StartJul 1, 2011
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.0 years ago

Interventions

Zicronapine open-label lead-in 10 mg dailydrug

Encapsulated tablet ,10 mg, once daily, open-label

Zicronapine 10 mg dailydrug

Encapsulated tablet, 10 mg, once daily, double-blind

Zicronapine 20 mg once weeklydrug

Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Zicronapine 30 mg once weeklydrug

Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Zicronapine 45 mg once weeklydrug

Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind