A dose-ranging trial in patients with post-herpetic neuralgia

• Research type

  Research Study

• Full title

  A double-blind, placebo-controlled, randomised dose ranging trial to determine the safety and efficacy of three dose levels of EMA401 in reducing 24-hour average pain intensity score in patients with post-herpetic neuralgia

• IRAS ID

  224514

• Contact name

  Emma Stephenson

• Contact email

  emma.stephenson@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2016-000280-16

• Duration of Study in the UK

  1 years, 5 months, 5 days

• Research summary

  The purpose of this study is to characterise dose response and evaluate safety and efficacy of up to three different oral doses of EMA401 (25 mg b.i.d., 100 mg b.i.d., 300 mg b.i.d.) compared to placebo in patients with post-herpetic neuralgia (PHN). Patients will be screened for up to four weeks then receive at random and double-blind, one of three doses of EMA401 or placebo for twelve weeks. They will be obliged to complete an electronic pain diary throughout the study and to complete a variety of questionnaires at study visits. As well as being on a stable dose of either gabapentin or pregabalin prior to study entry, patients can take rescue medication of up to 3g paracetamol daily. Data from this study will be used to inform the selection of EMA401 doses for future Phase III clinical trials.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  17/NW/0275

• Date of REC Opinion

  6 Jun 2017

• REC opinion

  Further Information Favourable Opinion