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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: February 22, 2016
Last verified: February 2016
Results First Received: January 15, 2016  
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
Condition: Schizophrenia
Interventions: Drug: Zicronapine open-label lead-in 10 mg daily
Drug: Zicronapine 10 mg daily
Drug: Zicronapine 20 mg once weekly
Drug: Zicronapine 30 mg once weekly
Drug: Zicronapine 45 mg once weekly

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
46 patients were initially enrolled in a 3-week open-label study period. The 42 patients who completed the open-label period were subsequently randomized to a 5-week double-blind period.

Reporting Groups
  Description
Zicronapine Open-label 10 mg Daily Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
Zicronapine Basis Dose 10 mg Daily Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
Zicronapine Low Dose 20 mg Once Weekly Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Zicronapine Med Dose 30 mg Once Weekly Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Zicronapine High Dose 45 mg Once Weekly Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Participant Flow for 2 periods

Period 1:   Open-label
    Zicronapine Open-label 10 mg Daily     Zicronapine Basis Dose 10 mg Daily     Zicronapine Low Dose 20 mg Once Weekly     Zicronapine Med Dose 30 mg Once Weekly     Zicronapine High Dose 45 mg Once Weekly  
STARTED     46     0     0     0     0  
COMPLETED     42     0     0     0     0  
NOT COMPLETED     4     0     0     0     0  
Adverse Event                 1                 0                 0                 0                 0  
Withdrawal by Subject                 3                 0                 0                 0                 0  

Period 2:   Double-blind
    Zicronapine Open-label 10 mg Daily     Zicronapine Basis Dose 10 mg Daily     Zicronapine Low Dose 20 mg Once Weekly     Zicronapine Med Dose 30 mg Once Weekly     Zicronapine High Dose 45 mg Once Weekly  
STARTED     0     11     10     11     10  
COMPLETED     0     10     8     7     8  
NOT COMPLETED     0     1     2     4     2  
Adverse Event                 0                 1                 2                 2                 0  
Protocol Violation                 0                 0                 0                 0                 1  
Withdrawal by Subject                 0                 0                 0                 1                 0  
Administrative or other                 0                 0                 0                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics for the 4 patients enrolled in the open-label period but not randomized to the double blinded period, are reported in the first (open-label) study arm. Baseline characteristics for the 42 patients who were subsequently randomized to the double-blind period are reported across the last four (randomized) study arms.

Reporting Groups
  Description
Zicronapine Open-label 10 mg Daily Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
Zicronapine 10 mg Daily Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
Zicronapine 20 mg Once Weekly Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Zicronapine 30 mg Once Weekly Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Zicronapine 45 mg Once Weekly Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Total Total of all reporting groups

Baseline Measures
    Zicronapine Open-label 10 mg Daily     Zicronapine 10 mg Daily     Zicronapine 20 mg Once Weekly     Zicronapine 30 mg Once Weekly     Zicronapine 45 mg Once Weekly     Total  
Number of Participants  
[units: participants]
  4     11     10     11     10     46  
Age  
[units: years]
Mean (Standard Deviation)
  38.5  (6.6)     42.7  (11.7)     47.8  (6.4)     50.8  (5.0)     50.1  (4.8)     47.0  (8.3)  
Gender  
[units: participants]
           
Female     1     4     4     4     4     17  
Male     3     7     6     7     6     29  
Race (NIH/OMB)  
[units: participants]
           
American Indian or Alaska Native     1     0     0     0     0     1  
Asian     0     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     1     0     0     1  
Black or African American     1     7     5     8     7     28  
White     2     4     4     3     3     16  
More than one race     0     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
           
United States     4     11     10     11     10     46  
Height  
[units: cm]
Mean (Standard Deviation)
  176.3  (9.4)     169.5  (8.3)     170.1  (9.7)     174.6  (10.3)     170.9  (11.7)     171.8  (9.8)  
Weight  
[units: kg]
Mean (Standard Deviation)
  94.7  (27.5)     90.0  (21.1)     91.5  (19.2)     87.5  (17.5)     93.8  (16.8)     89.7  (18.0)  
BMI  
[units: kg/m2]
Mean (Standard Deviation)
  30.0  (5.5)     31.3  (7.1)     31.6  (5.9)     28.6  (4.2)     32.2  (5.2)     30.4  (5.3)  
Waist circumference  
[units: cm]
Mean (Standard Deviation)
  98.7  (16.2)     99.8  (16.4)     101.8  (14.1)     101.1  (13.1)     106.5  (12.5)     103.3  (13.2)  



  Outcome Measures
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1.  Primary:   Number of Patients With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: 11 weeks for open-label period; 13 weeks for double-blind period ]

2.  Secondary:   Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline   [ Time Frame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period) ]

3.  Secondary:   Clinical Global Impression Severity Scale (CGI-S) Change From Baseline   [ Time Frame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period) ]

4.  Secondary:   Clinical Global Impression Improvement Scale (CGI-I)   [ Time Frame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study director
Organization: H. Lundbeck A/S
e-mail: LundbeckClinicalTrials@Lundbeck.com



Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01377233     History of Changes
Other Study ID Numbers: 13946A
Study First Received: June 20, 2011
Results First Received: January 15, 2016
Last Updated: February 22, 2016
Health Authority: United States: Food and Drug Administration