1. Study identification
EU PAS Register NumberEUPAS28735
Official titleAn observational, real world evidence study to describe clinical experience with lurasidone in the treatment of adult patients with schizophrenia in routine clinical practice in Europe.
Study title acronymLATUDA
Study typeObservational study
Brief description of the studyThis is an international, multi-centre observational, real world evidence study. This study will be conducted in 4 to 8 mental health centres in the United Kingdom (UK), Netherlands and Switzerland.
The study is based on both retrospective and prospective collection of data from patients’ medical records. It is a single group study without a comparator, to reflect real world clinical practice. There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required.
The population for this study is adult patients diagnosed with schizophrenia who received treatment with a medicine called lurasidone as part of their standard clinical care. It is expected to recruit 80 patients in total. The main purpose is to find out more about how lurasidone is used to treat patients with schizophrenia in the real world and how well it
works.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableNP-LAT-721-18
2. Research centres and Investigator details
Coordinating study entity
Centre nameDr Andrew Jones
Centre locationCNX Therapeutics Ltd (formerly Sunovion Pharmaceuticals Europe Ltd)
Details of (Primary) lead investigator
Title Dr
Last name Sargeant
First name Matthew
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?7
Countries in which this study is being conducted
International study
Netherlands
Switzerland
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/10/201718/10/2017
Start date of data collection04/02/201912/02/2019
Start date of data analysis29/05/202001/04/2021
Date of interim report, if expected
Date of final study report31/08/202006/12/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesCNX Therapeutics Ltd (formerly Sunovion Pharmaceuticals Ltd)100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Jones
First name Andrew
Address line 1CNX Therapeutics Ltd
Address line 23rd Floor, LABS House
Address line 315-19 Bloomsbury Way
CityLondon
PostcodeWC1A 2TH
CountryUnited Kingdom
Phone number (incl. country code)442078212899
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Jones
First name Andrew
Address line 1CNX Therapeutics Ltd
Address line 23rd Floor, LABS House
Address line 315-19 Bloomsbury Way
CityLondon
PostcodeWC1A 2TH
CountryUnited Kingdom
Phone number (incl. country code)442078212899
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Product NameLatuda
CountryUnited Kingdom
Substance INN(s)LURASIDONE HYDROCHLORIDE
7. Medical conditions to be studied
Medical condition(s)Yes
Schizophrenia
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects80
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Retrospective review of medical records following patient consent
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Drug utilisation study
Effectiveness evaluation
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
To describe the dose titration process, dosing regimens, treatment duration and reasons for discontinuation following initiation of lurasidone in adult patients with schizophrenia.
Are there primary outcomes?Yes
Summary measures of lurasidone treatment duration i.e. Proportion of patients taking treatment for full 12 months
Are there secondary outcomes?Yes
Summary measures of baseline demographics and clinical characteristics
Summary measures of treatment history for schizophrenia
Dose distribution of lurasidone prescribed and summary measures of dose regimen
Time until first relapse following lurasidone initiation
Adverse events following lurasidone initiation
Summary measures of healthcare resource utilisation
13. Study design
What is the design of the study?
Cohort study
Drug utilisation study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
All primary endpoint (and secondary endpoint) analyses will be descriptive in nature. For continuous variables (such as duration of time with disease) the mean, standard deviation, median, interquartile range and range will be calculated. For nominal variables, frequencies and proportions in the form of percentages will be calculated for each group.
For investigating changes in weight, blood glucose, lipid levels and liver function from
baseline at 3,6,9 and 12 months following initiation of lurasidone, changes will be described using summary measures as described for continuous variables above for each time; they will then be compared using a paired t-test (or Wilcoxon signed rank test if distributions are non-normal), although based upon a previous study of changes in weight(10) as a result of treatment change, it is expected that any change will be too small to detect a significant change with feasible sample size for the study.