Study to describe the use of buccal midazolam maleate (Epistatus®)
Research type
Research Study
Full title
A retrospective real world research study to describe the use of buccal midazolam maleate (Epistatus®) in adults in routine practice in the UK
IRAS ID
189756
Contact name
Rohit Shankar
Contact email
Sponsor organisation
Special Products Limited
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
Epilepsy is a complex neurological condition in which a person is prone to recurrent seizures. Usually epileptic seizures are self-limiting and patients regain consciousness within a few seconds or minutes. However in some patients seizures do not resolve spontaneously and a state known as status epilepticus is reached. The occurrence of status epilepticus is serious, increasing the likelihood of significant brain damage and even death.
The National Institute of Health and Care Excellence (NICE) recommend that prolonged seizures are treated with an emergency protocol which advocates benzodiazepine medication, followed by second line drugs, if necessary. The incidence of prolonged seizures in the community has led to the development of formulations of benzodiazepines that can be administered via rectal, oral (buccal) or nasal routes.
Buccal midazolam maleate (Epistatus®) is manufactured as a ‘Special’ by Special Products Limited. It does not currently have a product licence but has been manufactured for 12 years and has been prescribed by the NHS for the treatment of prolonged seizures in a variety of community settings. Given the wide use of Epistatus® within the community, there is an opportunity to describe its use in UK clinical practice.
This study is a retrospective, cross-sectional observational research study aiming to describe the dose of Epistatus® used to treat adult patients in routine practice in the UK based on the collection of data derived from medical records of approximately 200 patients. This study will also describe the patient characteristics and other factors influencing the dose of Epistatus® used in UK clinical practice in adult patients as well as describe the effectiveness of Epistatus® in UK routine clinical practice in adult patients.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0492
Date of REC Opinion
28 Oct 2015
REC opinion
Further Information Favourable Opinion