Study of Eslicarbazepine for nerve pain after shingles

• Research type

  Research Study

• Full title

  A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Post-Herpetic Neuralgia

• IRAS ID

  54308

• Contact name

  Stuart Ratcliffe

• Sponsor organisation

  BIAL - Portela & Cª, SA

• Eudract number

  2010-019101-42

• Clinicaltrials.gov Identifier

  NCT01124097

• Research summary

  Post-herpetic neuralgia (PHN) is a painful condition affecting nerve fibres and the skin following an attack of herpes zoster (shingles). Depending on the definition used for when herpes zoster pain becomes PHN, 10-15% of patients with herpes zoster will develop PHN. PHN is more common in older people and a further increase in the incidence of PHN is observed with advancing age. Chronic pain from PHN often impairs functioning and interferes with sleep which greatly reduces patients?? quality of life. More than 50% of patients fail to respond to medications or experience intolerable side effects. For this reason, there is a need to develop new effective and safe medications for PHN. Eslicarbazepine acetate (ESL) is approved as an additional therapy for adults with seizures and is being developed to treat other conditions including PHN. 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 PHN. 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 currently experiencing PHN for at least 6 months after resolution of herpes zoster rash. This study is sponsored by BIAL - Portela & C¦, SA. Approximately 392 patients will participate worldwide with 50 patients from 5 clinics in the UK.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/43

• Date of REC Opinion

  25 Jun 2010

• REC opinion

  Favourable Opinion