Back to resultsStudy of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zicronapine open-label lead-in 10 mg daily
Zicronapine 10 mg daily
Zicronapine 20 mg once weekly
Zicronapine 30 mg once weekly
Zicronapine 45 mg once weekly
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Antipsychotic, Zicronapine, Lu 31-310
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR)
- A score of <=4 (moderately ill) on Clinical Global Impression - Severity of Illness (CGI-S) scale
- A total score >=60 on Positive and Negative Syndrome Scale (PANSS)
- A score of <=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness)
Exclusion Criteria:
- Acute exacerbation requiring hospitalization within the last 3 months OR requiring change of antipsychotic medication within the last 4 weeks
- Diagnosis or history of substance dependence or substance abuse according to DSM-IV-TR within the last 3 months
- Significant risk of harming himself/herself or others
- Positive serology for hepatitis A, B, C, or HIV
- Present condition that might compromise liver function
- Medical or neurological disorder or treatment that could interfere with study treatment or compliance
- Previous exposure to zicronapine
Other inclusion and exclusion criteria may apply.
Sites / Locations
- US002
- US003
- US004
- US001
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Zicronapine open-label lead-in 10 mg daily
Zicronapine 10 mg daily
Zicronapine 20 mg once weekly
Zicronapine 30 mg once weekly
Zicronapine 45 mg once weekly
Arm Description
Outcomes
Primary Outcome Measures
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)
Secondary Outcome Measures
Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Clinical Global Impression Severity Scale (CGI-S) Change From Baseline
The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses their clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Clinical Global Impression Improvement Scale (CGI-I)
The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment is made independent of whether the rater believes the improvement is drug-related or not.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01377233
Brief Title
Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Antipsychotic, Zicronapine, Lu 31-310
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zicronapine open-label lead-in 10 mg daily
Arm Type
Experimental
Arm Title
Zicronapine 10 mg daily
Arm Type
Experimental
Arm Title
Zicronapine 20 mg once weekly
Arm Type
Experimental
Arm Title
Zicronapine 30 mg once weekly
Arm Type
Experimental
Arm Title
Zicronapine 45 mg once weekly
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zicronapine open-label lead-in 10 mg daily
Other Intervention Name(s)
Lu 31-130
Intervention Description
Encapsulated tablet ,10 mg, once daily, open-label
Intervention Type
Drug
Intervention Name(s)
Zicronapine 10 mg daily
Other Intervention Name(s)
Lu 31-130
Intervention Description
Encapsulated tablet, 10 mg, once daily, double-blind
Intervention Type
Drug
Intervention Name(s)
Zicronapine 20 mg once weekly
Other Intervention Name(s)
Lu 31-130
Intervention Description
Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Intervention Type
Drug
Intervention Name(s)
Zicronapine 30 mg once weekly
Other Intervention Name(s)
Lu 31-130
Intervention Description
Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Intervention Type
Drug
Intervention Name(s)
Zicronapine 45 mg once weekly
Other Intervention Name(s)
Lu 31-130
Intervention Description
Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Primary Outcome Measure Information:
Title
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Description
Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)
Time Frame
11 weeks for open-label period; 13 weeks for double-blind period
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline
Description
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame
8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
Title
Clinical Global Impression Severity Scale (CGI-S) Change From Baseline
Description
The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses their clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Time Frame
8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
Title
Clinical Global Impression Improvement Scale (CGI-I)
Description
The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment is made independent of whether the rater believes the improvement is drug-related or not.
Time Frame
8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR)
A score of <=4 (moderately ill) on Clinical Global Impression - Severity of Illness (CGI-S) scale
A total score >=60 on Positive and Negative Syndrome Scale (PANSS)
A score of <=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness)
Exclusion Criteria:
Acute exacerbation requiring hospitalization within the last 3 months OR requiring change of antipsychotic medication within the last 4 weeks
Diagnosis or history of substance dependence or substance abuse according to DSM-IV-TR within the last 3 months
Significant risk of harming himself/herself or others
Positive serology for hepatitis A, B, C, or HIV
Present condition that might compromise liver function
Medical or neurological disorder or treatment that could interfere with study treatment or compliance
Previous exposure to zicronapine
Other inclusion and exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
US002
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
US003
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
US004
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
US001
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
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