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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: May 14, 2014
Last verified: May 2014

June 20, 2011
May 14, 2014
July 2011
February 2012   (final data collection date for primary outcome measure)
Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability: Adverse event monitoring [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01377233 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Not Provided
February 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01377233
13946A
Yes
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
May 2014

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