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Efficacy and Safety of Eslicarbazepine Acetate as Therapy in Subjects With Fibromyalgia

NCT01820585 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2013-07-19

Study results available
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Summary

This was a double-blind, randomised, placebo-controlled, parallel-group, multicentre, multinational, Phase II study in 528 subjects with pain due to Fibromyalgia syndrome(FMS). Subjects were randomised in a 1:1:1:1 ratio to receive placebo, Eslicarbazepine acetate (ESL) 400 mg once daily (QD), ESL 800 mg QD or ESL 1200 mg QD. The study was carried out as follows.

Conditions

  • Fibromyalgia

Interventions

DRUG

Placebo

Tablets

DRUG

ESL 400 mg

tablets

DRUG

ESL 800 mg

tablets

DRUG

ESL 1200 mg

tablets

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Patricio Soares-da-Silva, MD, PhD · BIAL - Portela & Cª, S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-09-30
Completion
2010-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01820585 on ClinicalTrials.gov