EMA401 in reducing 24-hour average pain in PDN (EMPADINE)
Research type
Research Study
Full title
A double-blind, placebo-controlled, randomized trial to determine the safety and efficacy of EMA401 100 mg b.i.d. in reducing 24-hour average pain intensity score in patients with painful diabetic neuropathy (EMPADINE)
IRAS ID
238458
Contact name
Amandine Roemer
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2016-000281-39
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
The purpose of this study is to evaluate safety and efficacy of EMA401 100mg b.i.d compared to placebo in approximately 400 patients >18 years with painful diabetic neuropathy (PDN). Patients will be screened for up to four weeks then receive at random and double-blind, EMA401 or placebo to be taken orally for twelve weeks. Patients will be required to complete an electronic pain diary throughout the study and to complete a variety of questionnaires at study visits. In addition, patients will undergo physical examination plus ECG, blood and urine tests, vital signs checks and pregnancy testing (if applicable).
Patients will also be invited to provide additional consent for an optional genetic sub-study where an additional blood sample is taken for genetic biomarker analysis.
In the UK patients may also be enrolled into an optional Actigraphy sub-study looking at physical activity and sleep. Patients enrolled in the sub-study are required to wear a wrist worn device continuously while taking part in the main study.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0497
Date of REC Opinion
26 Jan 2018
REC opinion
Further Information Favourable Opinion