Study of Eslicarbazepine for nerve pain related to diabetes

• Research type

  Research Study

• Full title

  A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Diabetic Neuropathic Pain

• IRAS ID

  57635

• Contact name

  Stuart Ratcliffe

• Sponsor organisation

  BIAL - Portela & Cª, SA

• Eudract number

  2010-019100-23

• Clinicaltrials.gov Identifier

  NCT01129960

• Research summary

  Diabetic neuropathic pain (DNP) is one of the most common complications of diabetes. It is a painful condition causing symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs. It currently affects about 1% of the population but its prevalence is expected to increase in coming years along with an increase in diabetes prevalence. Pain and other symptoms usually increase during the night and often cause waking, so DNP is frequently associated with sleep disturbances and mood changes, which may impair quality of life. Nerve pain does not usually respond to conventional pain medication. Other medications have been tried with limited response and often undesirable side effects. For this reason, there is a need to develop new effective and safe medications for DNP. Eslicarbazepine acetate (ESL) is approved as an additional therapy for adults with seizures and is being developed to treat other conditions including DNP. 3500 people have participated in ESL studies to date and it has been generally well tolerated. The purpose of this study is to investigate the efficacy, safety and tolerability of ESL for treatment of DNP. During the test phase, participants will receive either placebo (dummy drug) or one of three ESL doses. In the extension phase all participants will receive ESL. The test phase involves seven clinic visits over up to 22« weeks and the 36-week extension phase involves six clinic visits. Procedures to be undertaken during these visits include physical examinations, blood sampling, vital signs, ECGs, questionnaires and pain assessments. The study will be conducted in patients with diabetes who have been experiencing DNP for at least 6 months. This study is sponsored by BIAL - Portela & C¦, SA. Approximately 468 patients will participate worldwide with 50 patients from 6 clinics in the UK.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/53

• Date of REC Opinion

  28 Jul 2010

• REC opinion

  Favourable Opinion