Eslicarbazepine Acetate as therapy in participants with Fibromyalgia

• Research type

  Research Study

• Full title

  Efficacy and safety of Eslicarbazepine Acetate as therapy in patients with Fibromyalgia: A double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial.

• IRAS ID

  3749

• Contact name

  Barbara Hoggart

• Sponsor organisation

  BIAL - Portela & Ca , S.A.

• Eudract number

  2008-003557-32

• ISRCTN Number

  n/a

• Research summary

  The new study involves the use of Eslicarbazepine Acetate (ESL) as a treatment for participant'suffering from pain due to a chronic condition that causes fatigue, pain in the muscles and ligaments, and known as Fibromyalgia. The aim of this study is to determine how well this drug will be in relieving pain felt by sufferers. This trial is a phase II, multi-national, randomised (drug given at random), double-blind (neither participants nor study doctors will know the nature of the tested drug), placebo-controlled (placebo being an inactive drug as compared to the active tested drug and being of identical shape/appearance), parallel-group (separated into 4 groups being tested equally) study involving approximately 480 subjects, firstly assessing the effectiveness of ESL and, secondly, to determine its safety within participants with Fibromyalgia. Participants will be treated with either ESL or placebo for a period of up to 13 weeks including a 1-week Titration period (with active treatment or placebo) and a 12-week Maintenance period where a fixed dose of active treatment or placebo will be dispensed. The randomisation of participants will be as a 1:1:1:1 ratio doses of placebo, ESL(400mg), ESL(800mg) or ESL(1200mg) to be received once-daily. The study will consist of a Screening Visit, a 2-week Screening period, a 1-week Titration period, a 12-week Maintenance period, and a Follow-up visit taking place about 2 weeks after the last dose of study drug. The follow-up period will require participants to be seen for follow-up in order to undergo the end of study evaluations. The study duration is expected to last in overall 14 months. Throughout the study, information regarding any occurring Adverse Events (AEs) related to the study drug or not will be recorded. Participants will be monitored at study centres for safety and will complete scheduled procedures and assessments of effectiveness, tolerance, and be monitored for any occurring AEs.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/39

• Date of REC Opinion

  21 Aug 2009

• REC opinion

  Further Information Favourable Opinion