Trial · NCT01820585

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

NCT01820585, Phase 2, Completed, Bial - Portela C S.A.; results first posted 2013-07-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Eslicarbazepine Acetate as Therapy in Subjects With Fibromyalgia. Trials, record NCT01820585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01820585

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Eslicarbazepine Acetate as Therapy in Subjects With Fibromyalgia
NCT number: NCT01820585
Status: Completed
Phases: Phase 2
Enrollment: 528 participants, actual
Lead sponsor: Bial - Portela C S.A.
Conditions: Fibromyalgia
Interventions: Placebo, ESL 400 mg, ESL 800 mg, ESL 1200 mg
First posted: 2013-03-29
Last updated: 2013-07-19
Results first posted: 2013-07-19

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Absolute Change From Baseline to Endpoint in Mean Pain	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Absolute Change From Baseline to Endpoint in Mean Pain	Baseline and 13 Weeks		units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Absolute Change From Baseline to Endpoint in Mean Pain	Placebo	-1.0	Standard Error 0.1735	units on a scale
Absolute Change From Baseline to Endpoint in Mean Pain	ESL 400 mg	-0.8	Standard Error 0.1731	units on a scale
Absolute Change From Baseline to Endpoint in Mean Pain	ESL 800 mg	-1.2	Standard Error 0.1704	units on a scale
Absolute Change From Baseline to Endpoint in Mean Pain	ESL 1200 mg	-0.8	Standard Error 0.1734	units on a scale

Source ClinicalTrials.gov

Participant flow32

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	131
Overall Study	STARTED	ESL 400 mg	130
Overall Study	STARTED	ESL 800 mg	135
Overall Study	STARTED	ESL 1200 mg	132
Overall Study	Randomized and Treated	Placebo	131
Overall Study	Randomized and Treated	ESL 400 mg	130
Overall Study	Randomized and Treated	ESL 800 mg	135
Overall Study	Randomized and Treated	ESL 1200 mg	132
Overall Study	Full Analysis Set	Placebo	131
Overall Study	Full Analysis Set	ESL 400 mg	130

1 to 10 of 32Source ClinicalTrials.gov

See all 32 participant flow

Adverse events152

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Placebo	16	131	16
other	Headache	Nervous system disorders	ESL 400 mg	18	130	18
other	Headache	Nervous system disorders	ESL 800 mg	19	135	19
other	Headache	Nervous system disorders	ESL 1200 mg	25	132	25
other	Nausea	Gastrointestinal disorders	Placebo	10	131	10
other	Nausea	Gastrointestinal disorders	ESL 400 mg	10	130	10
other	Nausea	Gastrointestinal disorders	ESL 800 mg	17	135	17
other	Nausea	Gastrointestinal disorders	ESL 1200 mg	21	132	21
other	Dizziness	Nervous system disorders	Placebo	6	131	6
other	Dizziness	Nervous system disorders	ESL 400 mg	7	130	7

1 to 10 of 152Source ClinicalTrials.gov

See all 152 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	ESL 400 mg
Total, all-cause mortality	ESL 800 mg
Total, all-cause mortality	ESL 1200 mg
Total, other adverse events	Placebo	75	131
Total, other adverse events	ESL 400 mg	86	130
Total, other adverse events	ESL 800 mg	92	135
Total, other adverse events	ESL 1200 mg	93	132
Total, serious adverse events	Placebo	3	131
Total, serious adverse events	ESL 400 mg	5	130

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01820585

GET https://conductscience.org/api/trials/v1/NCT01820585/flow?page=2

API reference For AI assistants