Study of the Safety, Tolerability and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
This study has been completed.
Sponsor:
H. Lundbeck A/S
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Zicronapine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by H. Lundbeck A/S:
Primary Outcome Measures:
- Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 42 |
| Study Start Date: | July 2011 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Zicronapine basis dose daily |
Drug: Zicronapine
basis dose daily
Other Name: Lu 31-130
|
| Experimental: Zicronapine lowest dose once weekly |
Drug: Zicronapine
lowest comparison dose on day 1 of each 7 day cycle
Other Name: Lu 31-130
|
| Experimental: Zicronapine medium dose once weekly |
Drug: Zicronapine
medium comparison dose on day 1 of each 7 day cycle
Other Name: Lu 31-130
|
| Experimental: Zicronapine highest dose once weekly |
Drug: Zicronapine
highest comparison dose on day 1 of each 7 day cycle
Other Name: Lu 31-130
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377233
Locations
| United States, California | |
| US002 | |
| Garden Grove, California, United States, 92845 | |
| US003 | |
| National City, California, United States, 91950 | |
| US004 | |
| San Diego, California, United States, 92102 | |
| United States, Maryland | |
| US001 | |
| Rockville, Maryland, United States, 20850 | |
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
More Information
No publications provided
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT01377233 History of Changes |
| Other Study ID Numbers: | 13946A |
| Study First Received: | June 20, 2011 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by H. Lundbeck A/S:
|
Schizophrenia Antipsychotic Zicronapine Lu 31-310 |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013