A study of oral EMA401 in the treatment of painful diabetic neuropathy
Research type
Research Study
Full title
A double-blind, placebo-controlled, randomized trial to determine the safety and efficacy of EMA401 in patients with painful diabetic neuropathy
IRAS ID
173175
Contact name
Andrew Rice
Contact email
Sponsor organisation
Spinifex Pharmaceuticals Pty Ltd
Eudract number
2015-000808-25
Clinicaltrials.gov Identifier
78,625, IND
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
This study will assess the efficacy and safety of 300 mg BID (twice daily) EMA401 in PDN patients. BID (Twice daily) dosing has been selected because the terminal half-life of EMA401 allows BID dosing without risk of accumulation. A dose of 300 mg BID (Twice daily) was selected to assess efficacy in this patient population because this currently is the highest dose to be studied in the Phase 2 clinical program.
The proposed study, EMA401-011, is a randomised, double blind, placebo controlled trial
comparing the efficacy and safety of EMA401 versus placebo in Painful Diabetic Neuropathy (PDN). This study will assess the safety and efficacy of EMA401 in participants with Painful Diabetic Neuropathy(PDN).Approximately 180 participants, male and female, aged 18 years or over with painful diabetic neropathy will be eligible for this study. The sites where the study will be conducted will be NHS hospital sites. The screening period will last up to 4 weeks and the on-study treatment period will be a total of 12 weeks.
During the screening period potential participants will be given:-
Physical examination/mdeical history and fulfilment of eligibility criteria including a pain assessment. Participants will be washed off any prohibited concomitant medications. The assessment of mederate and sever pain will be made using an algorithim. Participants who fulfill the criteria for screening assessments will be required to attend the clinic to collect their electronic patient reported outcome (ePRO) elecrtonic diary (eDiary) device approximately 7 days prior to the baseline visit. They will be required to sign a consent form prior to any screening procedures being performed.During the treatment period eligable participants will be randomised to receive either EMA401 (300mg) twice daily or placebo. Visits will be at the end of Weeks 3, 6, 9 and 12. Investigational product (IP) (EMA401 or placebo) will be self-administered at home.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
15/EM/0292
Date of REC Opinion
27 Jul 2015
REC opinion
Unfavourable Opinion