Efficacy and safety of eslicarbazepine acetate as therapy in patients with fibromyalgia: a double-blind, randomized, placebo-controlled, parallel-group, multicentre clinical trial.
Recruiting
- Conditions
- Fibromyalgia
- Registration Number
- NL-OMON24699
- Lead Sponsor
- BIAL - Portela & Ca, S.A.À Av. da Siderurgia Nacional4745 457 S. Mamede do CoronadoPortugalPhone: +351-229866100Fax: +351-229866192http://www.bial.com.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 480
Inclusion Criteria
Main Inclusion Criteria at V1:
1. Patient is male or female, aged 18 or older;
Exclusion Criteria
Main Exclusion Criteria:
1. Patient has any of the following: an inflammatory muscle or rheumatologic disease other than FMS; multiple sclerosis; active infections; untreated endocrine disorders; uncontrolled hypo or hyper thyroidism of any type;
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess the efficacy of ESL as therapy in patients with FMS.<br><br /><br /><br>The primary efficacy variable will be the change from baseline (the mean of the last 4 patient diary pain assessment scores) to endpoint (mean over the last 4 diary pain intensity scale assessments from the last 7 days before V6) in mean pain.
- Secondary Outcome Measures
Name Time Method The secondary objective of this study is to assess the safety and tolerability of ESL in patients with FMS.<br><br /><br /><br>There will be two key secondary efficacy variables: 30% responder rate at endpoint and the 30% weekly responder rate.<br>Other secondary efficacy variables based on the pain scores will be 50% responder rates and mean pain intensity per week.<br>Further secondary efficacy variables will be: Fibromyalgia as assessed by the Fibromyalgia Impact Questionnaire, Patient Global Impression of Change (PGIC), Clinician Global Impression of Change (CGIC), depression as assessed by the<br>Montgomery Åsberg Depression Rating Scale (MADRS), tender point count, sleep<br>interference as assessed by the Medical Outcome Study (MOS) Sleep Scale, quality of life as assessed by the SF-36 Health Survey, and intake of rescue medication.