|- candidate number||6862|
|- NTR Number||NTR2167|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jan-2010|
|- Secondary IDs||BIA-2093-210 BIAL-Portela & Ca, S.A.|
|- Public Title||Efficacy and safety of eslicarbazepine acetate as therapy in patients with fibromyalgia: a double-blind, randomized, placebo-controlled, parallel-group, multicentre clinical trial.|
|- Scientific Title||Efficacy and safety of eslicarbazepine acetate as therapy in patients with fibromyalgia: a double-blind, randomized, placebo-controlled, parallel-group, multicentre clinical trial.|
|- Healt Condition(s) or Problem(s) studied||Fibromyalgia|
|- Inclusion criteria||Main Inclusion Criteria at V1:|
1. Patient is male or female, aged 18 or older;
2. Patient meets the ACR 1990 diagnostic criteria for FMS (widespread pain for at least 3 months and pain in at least 11 of 18 tender points);
3. Patient use of allowable nonpharmacological therapies must have been stable for at least 4 weeks prior to V1 (Screening Visit) and must be maintained at the stable regimen throughout the study.
|- 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;
2. Patients whose pain is not due primarily to FMS;
3. Patient underwent tender point injection within 30 days before V1 (Screening Visit) and/or patient is unwilling to refrain from tender point injection throughout the study;
4. Patient has abnormal values for antinuclear antibody (ANA > 1/160) or rheumatoid factor (RF > 15 IU/mL) at V1 (Screening Visit);
5. Patient has abnormal Westergren erythrocyte sedimentation rate (ESR) at V1 (Screening Visit) (ESR > 40 mm/h);
6. Patient has creatinine clearance lower than 60 mL/min at Screening;
7. Patient has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥ 35 or a score of 4 to 6 on question 10 of the MADRS at V1 (Screening Visit);
8. Patient used prohibited concomitant medications during the 2 week Baseline Period or used fluoxetine during the 30 days before V1 (Screening Visit);
9. Patient used opiates every day for the 30 days before V1 (Screening Visit) for the control of pain related to FMS.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||21-apr-2009|
|- planned closingdate||31-aug-2010|
|- Target number of participants||480|
|- Interventions||Patients will be treated with either ESL (400 mg QD, 800 mg QD or 1200 mg QD) or placebo for a period of up to 13 weeks. |
|- Primary outcome||The primary objective of this study is to assess the efficacy of ESL as therapy in patients with FMS.
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||The secondary objective of this study is to assess the safety and tolerability of ESL in patients with FMS.
There will be two key secondary efficacy variables: 30% responder rate at endpoint and the 30% weekly responder rate.
Other secondary efficacy variables based on the pain scores will be 50% responder rates and mean pain intensity per week.
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
Montgomery Åsberg Depression Rating Scale (MADRS), tender point count, sleep
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.
|- Timepoints||The primary efficacy variable will be the change from baseline to endpoint in mean pain.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD Patricio Soares Silva, da|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD Patricio Soares Silva, da|
|- Sponsor/Initiator ||BIAL - Portela & Ca, S.A.|
(Source(s) of Monetary or Material Support)
|BIAL - Portela & Ca, S.A.|
|- Brief summary||Recruiting countries: Austria, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Poland, Portugal, Netherlands, Romania, Serbia, Slovakia, Spain, United Kingdom and Ukraine.|
|- Main changes (audit trail)|
|- RECORD||11-jan-2010 - 26-feb-2010|