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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

H. Lundbeck A/S

ClinicalTrials.gov Identifier:

NCT01377233

First received: June 20, 2011

Last updated: March 26, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 20, 2011

Last Updated Date

March 26, 2013

Start Date ^ICMJE

July 2011

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety and tolerability: Adverse event monitoring [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01377233 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Plasma concentrations of zicronapine and its metabolite Lu AA22774 [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Positive and Negative Syndrome Scale (PANSS) total and subscales change from baseline [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression Severity Scale (CGI-S) change from baseline [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression Improvement Scale (CGI-I) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of once-a-week 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 into the study and continue for 3 weeks; during which all patients will receive treatment with zicronapine daily. 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 treatment with zicronapine daily and 3 groups receiving once-a-week treatment with zicronapine.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Zicronapine
basis dose daily

Other Name: Lu 31-130
Drug: Zicronapine
lowest comparison dose on day 1 of each 7 day cycle

Other Name: Lu 31-130
Drug: Zicronapine
medium comparison dose on day 1 of each 7 day cycle

Other Name: Lu 31-130
Drug: Zicronapine
highest comparison dose on day 1 of each 7 day cycle

Other Name: Lu 31-130

Study Arm (s)

Active Comparator: Zicronapine basis dose daily
Intervention: Drug: Zicronapine
Experimental: Zicronapine lowest dose once weekly
Intervention: Drug: Zicronapine
Experimental: Zicronapine medium dose once weekly
Intervention: Drug: Zicronapine
Experimental: Zicronapine highest dose once weekly
Intervention: Drug: Zicronapine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV)
A severity score of Clinical Global Impression Scale (CGI) >=4
A total score of Positive and Negative Syndrome Scale (PANSS) >=60
A score of <=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness)

Exclusion Criteria:

Acute exacerbation which required hospitalization within the last 3 months OR required change of antipsychotic medication within the last 4 weeks
A current diagnosis or a history of substance dependence or substance abuse according to the DSM-IV-TR in the past 3 months
A significant risk of harming himself/herself or others
A positive serology for Hepatitis A, B, C, or HIV
A present condition that might compromise liver function
A medical or neurological disorder or treatment that could interfere with study treatment or compliance

Other inclusion and exclusion criteria may apply.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01377233

Other Study ID Numbers ^ICMJE

13946A

Has Data Monitoring Committee

Yes

Responsible Party

H. Lundbeck A/S

Study Sponsor ^ICMJE

H. Lundbeck A/S

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

Information Provided By

H. Lundbeck A/S

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top