Clinical Trial Results:
A Twelve Week, Multicenter, Open Label Extension Study in Subjects with Schizophrenia
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Summary
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EudraCT number |
2011-004790-90 |
Trial protocol |
SK IT |
Global end of trial date |
01 Nov 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Oct 2016
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First version publication date |
15 Oct 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
D1050307
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01566162 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Sunovion Pharmceuticals Inc.
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Sponsor organisation address |
One Bridge Plaza North, Suite 510, Fort Lee, United States, 07024
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Public contact |
Manager, Sunovion Pharmaceuticals Inc., 001 8665036351, clinicaltrialdisclosure@sunvion.com
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Scientific contact |
Medical Director, Sunovion Pharmaceuticals Inc., 001 8665036351, clinicaltrialdisclosure@sunvion.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Nov 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Nov 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Nov 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.
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Protection of trial subjects |
none
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Serbia: 22
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Country: Number of subjects enrolled |
France: 4
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Country: Number of subjects enrolled |
United States: 114
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Country: Number of subjects enrolled |
Slovakia: 15
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Country: Number of subjects enrolled |
Russian Federation: 19
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Country: Number of subjects enrolled |
South Africa: 17
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Worldwide total number of subjects |
191
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EEA total number of subjects |
19
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
190
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects who completed the 28-week double-blind phase or who experienced a protocol-defined relapse event during the double-blind phase in Study D1050238 were eligible to participate. In addition, subjects who were participating in the open-label or double-blind phase of Study D1050238 at the point in time when the study was terminated. | ||||||||||||||||||||
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Pre-assignment
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Screening details |
All eligible subjects were transitioned immediately from Study D1050238. A total of up to 7 days hospitalization was permitted from the completion/termination of Study D1050238 through the first week of this extension study. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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Lurasidone | ||||||||||||||||||||
Arm description |
Lurasidone 40 – 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
lurasidone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
lurasidone 40 - 80mg flexible dose/once daily
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Baseline characteristics reporting groups
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Reporting group title |
Lurasidone
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Reporting group description |
Lurasidone 40 – 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Lurasidone
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Reporting group description |
Lurasidone 40 – 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily | ||
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End point title |
Safety - Treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs) [1] | ||||||||||||||
End point description |
Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)
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End point type |
Primary
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End point timeframe |
12 weeks
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The rational with regards no statistical analyses performed for primary outcome of 307: because this is the extension study of D1050238, and every subject took lurasidone during the study, and thus only one treatment group is reported and no statistical analyses can be performed. |
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) total score [2] | ||||||||
End point description |
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
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End point type |
Primary
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End point timeframe |
Baseline to week 12 LOCF endpoint
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The rational with regards no statistical analyses performed for primary outcome of 307: because this is the extension study of D1050238, and every subject took lurasidone during the study, and thus only one treatment group is reported and no statistical analyses can be performed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Efficacy - Change from baseline in Clinical Global Impression-Severity of Illness (CGI-S) score. [3] | ||||||||
End point description |
The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.
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End point type |
Primary
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End point timeframe |
Baseline to week 12 LOCF endpoint
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The rational with regards no statistical analyses performed for primary outcome of 307: because this is the extension study of D1050238, and every subject took lurasidone during the study, and thus only one treatment group is reported and no statistical analyses can be performed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change from baseline in Montgomery -Asberg Depression Rating Scale total score | ||||||||
End point description |
The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
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End point type |
Secondary
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End point timeframe |
Baseline to week 12 LOCF endpoint
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| No statistical analyses for this end point | |||||||||
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End point title |
Short Form-12 Health Survey (SF-12) | ||||||||
End point description |
The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
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End point type |
Secondary
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End point timeframe |
Baseline to week 12 LOCF endpoint
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| No statistical analyses for this end point | |||||||||
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End point title |
Modified Specific Levels of Functioning (SLOF) total score. | ||||||||
End point description |
The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition.
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End point type |
Secondary
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End point timeframe |
12 weeks
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| No statistical analyses for this end point | |||||||||
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End point title |
Brief Adherence Rating Scale (BARS) | ||||||||
End point description |
The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month.
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End point type |
Secondary
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End point timeframe |
12 weeks
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| No statistical analyses for this end point | |||||||||
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End point title |
Smoking questionnaire | ||||||||
End point description |
Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).
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End point type |
Secondary
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End point timeframe |
12 weeks
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| No statistical analyses for this end point | |||||||||
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End point title |
Intent to Attend assessment | ||||||||
End point description |
The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = “Not at all” and 9 = “Extremely”. The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: “How likely is it that you will complete the study?”
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End point type |
Secondary
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End point timeframe |
12 weeks
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
12 Weeks
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.0
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Reporting groups
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Reporting group title |
Lurasidone
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Reporting group description |
Lurasidone 40 – 80mg flexible dose Lurasidone: Lurasidone 40-80 mg taken orally taken once daily | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
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