FibromyalgiaPhase 2NCT01820585
Efficacy and Safety of Eslicarbazepine Acetate as Therapy in Subjects With Fibromyalgia
A Phase 2 study testing ESL 400 mg, ESL 800 mg and ESL 1200 mg in people with Fibromyalgia, run by Bial - Portela C S.A..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- ESL 400 mg, ESL 800 mg and ESL 1200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 528 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Sep 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject was male or female, 18 years of age or older (according to Amendment #1 for Czech Republic [24 MARCH 2009]: 18 to 65 years of age).
- Subject was able and willing to provide written informed consent to participate in the study after having the opportunity to review the Subject Information Sheet and Informed Consent Form.
- Subject met the American College of Rheumatology (ACR) 1990 diagnostic criteria for FMS (widespread pain for at least 3 months and pain in at least 11 of 18 tender points) (according to Amendment #1 for Czech Republic [24 MARCH 2009]: and the subject's current FMS treatment was either inefficacious or had intolerable side effects).
- Subject was willing and able to understand and comply with all study requirements, in the judgment of the investigator.
- Subject had negative results on the urine test for drugs of abuse at V1 (Screening Visit), except for medications/drugs reported by the subject at the Screening Visit.
- Subject use of allowable non-pharmacological therapies was stable for at least 4 weeks prior to V1 (Screening Visit) and would be maintained at the stable regimen throughout the study.
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- Female subject was surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or at least 2 years post-menopausal or, if of childbearing potential, she was sexually abstinent or agreed to use a medically acceptable non-hormonal method of contraception
- Addendum according to Amendment #1 for Czech Republic [24 MARCH 2009]: Hormonal contraceptives were not acceptable as a contraceptive method in this study. However, their intake was not forbidden throughout the study.
- Addendum according to Amendment #1 for Spain [19 JANUARY 2009] and for United Kingdom [24 MARCH 2009]: Male subject was sexually abstinent or agreed to use reliable contraceptive methods (i.e. double-barrier method: 1 male barrier [male condom] plus 1 female barrier method [female condom, spermicide or intrauterine device]. This was mandatory even for sexually active men who had been sterilised.
- Subject had a negative urine test for drugs of abuse.
- The subject had completed at least 4 subject diary pain assessments satisfactorily within the past 7 days prior to V2 and the average pain score was ≥4 and ≤9.
Who cannot join
- Subject had a known hypersensitivity to ESL or to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients.
- Subject had a history of or current active malignancy except for the following: basal cell carcinoma which had been treated; and malignancies that were successfully treated and had no recurrence within 5 years before V1 (Screening Visit).
- Subject had a severe hepatic, renal, respiratory, hematologic or immunologic illness, unstable cardiovascular disease or any other medical or psychiatric condition that, in the judgment of the investigator, made the subject inappropriate for entry into this study.
- Subject had a second or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead ECG as determined by the investigator.
- Subject had a history of illicit drug or alcohol abuse within 2 years before V1 (Screening Visit).
- Subject had received an investigational drug (or a medical device) within 3 months of Screening or was currently participating in another study of an investigational drug (or a medical device).
Show all 19Show fewer
- Subject was pregnant or nursing.
- Subject was an employee of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre or was a family member of the employees or the investigator.
- Subject had 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.
- Subjects whose pain was not due primarily to FMS.
- Subject underwent tender point injection within 30 days before V1 (Screening Visit) and/or subject was unwilling to refrain from tender point injection throughout the study.
- Subject had a white blood cell (WBC) count <2.5 × 109/L, neutrophil count <1.5 × 109/L, Na+ <125 mmol/L or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 × the upper limit of normal at V1 (Screening Visit) or any other clinically relevant laboratory abnormality that, in the investigator's opinion, could compromise the subject's safety.
- Subject had abnormal values for antinuclear antibody (ANA >1/160) or rheumatoid factor (RF >15 IU/mL) at V1 (Screening Visit). After approval of the global amendment in respective countries, the limit for ANA was changed to ≥1/160.
- Subject had abnormal Westergren erythrocyte sedimentation rate (ESR) at V1 (Screening Visit) (ESR >40 mm/h).
- Subject had creatinine clearance (CLCr) lower than 60 mL/min at Screening.
- Subject had 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).
- Subject used prohibited concomitant medications during the 2-week Baseline Period or used fluoxetine during the 30 days before V1 (Screening Visit).
- Subject used opiates every day for the 30 days before V1 (Screening Visit) for the control of pain related to FMS.
- Subject had a MADRS total score ≥35 or a score of 4 to 6 on question 10 of the MADRS.
About this study
Official title: Efficacy and Safety of Eslicarbazepine Acetate as Therapy in Subjects With Fibromyalgia: a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial
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.
Read the detailed description
This was a double-blind, randomised, placebo-controlled, parallel-group, multicentre, multinational, Phase II study in 528 subjects with pain due to FMS. Subjects were randomised in a 1:1:1:1 ratio to receive placebo, ESL 400 mg once daily (QD), ESL 800 mg QD or ESL 1200 mg QD. The study was carried out as follows:
Screening Visit (Visit [V] 1): After completing screening procedures at V1, eligible subjects began the 2 week Baseline Period.
Baseline Period (2 weeks): Subjects discontinued taking prohibited medications on V1 (beginning of washout period). Subjects were tapered off of discontinued medications. Washout was completed by Day -7 (7 days before V2). Subjects refrained from taking any pain medications and other prohibited medications (except rescue medication) throughout the study. During the Baseline Period, subjects used the subject diary to complete the diary pain assessment on a 0-10 numeric pain rating scale (NPRS) and to record information on rescue medication daily on awakening.
Titration Period (1 week): Upon completing the Baseline Period, subjects returned to the study centre for V2 (Randomisation Visit, Day 1). At V2, subjects, who had completed at least 4 subject diary pain assessments satisfactorily within the past 7 days, had an average pain score that was ≥4 and ≤9 and continued to meet all study entry criteria, were randomly assigned to 1 of the 4 treatment groups. During the 1-week Titration Period, subjects randomised to the ESL 400 mg QD and the ESL 800 mg QD treatment groups received ESL 400 mg QD; and subjects randomised to the ESL 1200 mg QD treatment group received ESL 600 mg QD; subjects assigned to placebo treatment received placebo QD.
Maintenance Period (12 weeks): Starting at V3, subjects assigned to treatment with ESL received their full dosage regimens QD; subjects assigned to placebo treatment received placebo QD. During the Maintenance Period, subjects had visits every 4 weeks.
Follow-up Period (2 weeks): Approximately 2 weeks after taking the last dose of study medication, subjects returned to the study centre for the Follow-up Visit and underwent the end-of-study evaluations.
- Conditions
- Fibromyalgia
- Being tested
- Placebo, ESL 400 mg, ESL 800 mg, ESL 1200 mg
- Keywords
- fibromyalgia, Eslicarbazepine acetate (BIA 2-093), ESL
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Sugar pills
Tablets
ESL 400 mgDrug
Also called Eslicarbazepine acetate (BIA 2-093)
tablets
ESL 800 mgDrug
Also called Eslicarbazepine acetate (BIA 2-093)
tablets
ESL 1200 mgDrug
Also called Eslicarbazepine acetate (BIA 2-093)
tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Tablets Receives: Drug: Placebo |
| ESL 400 mg | Active comparator | Eslicarbazepine acetate (BIA 2-093) tablets Receives: Drug: ESL 400 mg |
| ESL 800 mg | Active comparator | Eslicarbazepine acetate (BIA 2-093) tablets Receives: Drug: ESL 800 mg |
| ESL 1200 mg | Active comparator | Eslicarbazepine acetate (BIA 2-093) tablets Receives: Drug: ESL 1200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline to Endpoint in Mean Pain
The primary efficacy variable was the absolute change from baseline to endpoint in mean pain. Pain intensity was assessed on an 11-point (0-10) Numeric pain rating scale (NPRS), where 0 = no pain and 10 = worst possible pain and was recorded in a subject's diary. The subject was instructed to complete the assessment daily on awakening.Primary analyses were conducted on the full analysis set (FAS) which consisted of all randomised subjects who received at least 1 dose of study medication and with at least 1 post-randomisation rating of 24-h-average pain. The primary efficacy variable was the absolute change from baseline to endpoint in mean pain recorded in a subject's diary upon awakening each morning. An ANCOVA on the FAS revealed no statistically significant differences between the 3 ESL groups and the placebo group after 13 weeks of treatment.
Measured: Baseline and 13 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startApr 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricio Soares-da-Silva, MD, PhD, Study director, BIAL - Portela & Cª, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820585
- Sponsor's protocol ID
- BIA-2093-210
- Status last verified
- Jun 2013
- First submitted
- 26 Mar 2013
- Last updated
- 19 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Eslicarbazepine Acetate as Therapy in Subjects With Fibromyalgia: a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial
- ClinicalTrials.gov ID
- NCT01820585
- Acronym / sponsor ID
- BIA-2093-210
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, Eslicarbazepine acetate (BIA 2-093), ESL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 29 Mar 2013 (estimated)
- Results
- Posted 19 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a double-blind, randomised, placebo-controlled, parallel-group, multicentre, multinational, Phase II study in 528 subjects with pain due to FMS. Subjects were randomised in a 1:1:1:1 ratio to receive placebo, ESL 400 mg once daily (QD), ESL 800 mg QD or ESL 1200 mg QD. The study was carried out as follows:
Screening Visit (Visit [V] 1): After completing screening procedures at V1, eligible subjects began the 2 week Baseline Period.
Baseline Period (2 weeks): Subjects discontinued taking prohibited medications on V1 (beginning of washout period). Subjects were tapered off of discontinued medications. Washout was completed by Day -7 (7 days before V2). Subjects refrained from taking any pain medications and other prohibited medications (except rescue medication) throughout the study. During the Baseline Period, subjects used the subject diary to complete the diary pain assessment on a 0-10 numeric pain rating scale (NPRS) and to record information on rescue medication daily on awakening.
Titration Period (1 week): Upon completing the Baseline Period, subjects returned to the study centre for V2 (Randomisation Visit, Day 1). At V2, subjects, who had completed at least 4 subject diary pain assessments satisfactorily within the past 7 days, had an average pain score that was ≥4 and ≤9 and continued to meet all study entry criteria, were randomly assigned to 1 of the 4 treatment groups. During the 1-week Titration Period, subjects randomised to the ESL 400 mg QD and the ESL 800 mg QD treatment groups received ESL 400 mg QD; and subjects randomised to the ESL 1200 mg QD treatment group received ESL 600 mg QD; subjects assigned to placebo treatment received placebo QD.
Maintenance Period (12 weeks): Starting at V3, subjects assigned to treatment with ESL received their full dosage regimens QD; subjects assigned to placebo treatment received placebo QD. During the Maintenance Period, subjects had visits every 4 weeks.
Follow-up Period (2 weeks): Approximately 2 weeks after taking the last dose of study medication, subjects returned to the study centre for the Follow-up Visit and underwent the end-of-study evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTablets |
| ESL 400 mg | Active comparator | Drug: ESL 400 mgEslicarbazepine acetate (BIA 2-093) tablets |
| ESL 800 mg | Active comparator | Drug: ESL 800 mgEslicarbazepine acetate (BIA 2-093) tablets |
| ESL 1200 mg | Active comparator | Drug: ESL 1200 mgEslicarbazepine acetate (BIA 2-093) tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject was male or female, 18 years of age or older (according to Amendment #1 for Czech Republic [24 MARCH 2009]: 18 to 65 years of age).
- Subject was able and willing to provide written informed consent to participate in the study after having the opportunity to review the Subject Information Sheet and Informed Consent Form.
- Subject met the American College of Rheumatology (ACR) 1990 diagnostic criteria for FMS (widespread pain for at least 3 months and pain in at least 11 of 18 tender points) (according to Amendment #1 for Czech Republic [24 MARCH 2009]: and the subject's current FMS treatment was either inefficacious or had intolerable side effects).
- Subject was willing and able to understand and comply with all study requirements, in the judgment of the investigator.
- Subject had negative results on the urine test for drugs of abuse at V1 (Screening Visit), except for medications/drugs reported by the subject at the Screening Visit.
Key exclusion criteria (19 listed)
- Subject had a known hypersensitivity to ESL or to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients.
- Subject had a history of or current active malignancy except for the following: basal cell carcinoma which had been treated; and malignancies that were successfully treated and had no recurrence within 5 years before V1 (Screening Visit).
- Subject had a severe hepatic, renal, respiratory, hematologic or immunologic illness, unstable cardiovascular disease or any other medical or psychiatric condition that, in the judgment of the investigator, made the subject inappropriate for entry into this study.
- Subject had a second or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead ECG as determined by the investigator.
- Subject had a history of illicit drug or alcohol abuse within 2 years before V1 (Screening Visit).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Sugar pillsTablets | Drug | Placebo |
| ESL 400 mgAlso: Eslicarbazepine acetate (BIA 2-093)tablets | Drug | ESL 400 mg |
| ESL 800 mgAlso: Eslicarbazepine acetate (BIA 2-093)tablets | Drug | ESL 800 mg |
| ESL 1200 mgAlso: Eslicarbazepine acetate (BIA 2-093)tablets | Drug | ESL 1200 mg |
Primary outcome
Absolute Change From Baseline to Endpoint in Mean Pain
Time frame: Baseline and 13 Weeks
The primary efficacy variable was the absolute change from baseline to endpoint in mean pain. Pain intensity was assessed on an 11-point (0-10) Numeric pain rating scale (NPRS), where 0 = no pain and 10 = worst possible pain and was recorded in a subject's diary. The subject was instructed to complete the assessment daily on awakening.Primary analyses were conducted on the full analysis set (FAS) which consisted of all randomised subjects who received at least 1 dose of study medication and with at least 1 post-randomisation rating of 24-h-average pain. The primary efficacy variable was the absolute change from baseline to endpoint in mean pain recorded in a subject's diary upon awakening each morning. An ANCOVA on the FAS revealed no statistically significant differences between the 3 ESL groups and the placebo group after 13 weeks of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricio Soares-da-Silva, MD, PhD study director
BIAL - Portela & Cª, S.A.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ESL 400 mg, ESL 800 mg and ESL 1200 mg in people with Fibromyalgia, run by Bial - Portela C S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change From Baseline to Endpoint in Mean Pain (time frame: Baseline and 13 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2013.