Trial · NCT01820559

Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine

NCT01820559, Phase 2, Completed, Bial - Portela C S.A.; results first posted 2013-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine. Trials, record NCT01820559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01820559

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 Preventive Therapy for Subjects With Migraine
NCT number: NCT01820559
Status: Completed
Phases: Phase 2
Enrollment: 452 participants, actual
Lead sponsor: Bial - Portela C S.A.
Conditions: Migraine
Interventions: Placebo, ESL 1200 mg, ESL 800 mg
First posted: 2013-03-29
Last updated: 2013-05-24
Results first posted: 2013-05-24

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 in the Frequency of Migraine Attacks	4 weeks	The primary efficacy variable was the absolute change from baseline in the frequency of migraine attacks standardised to 4 weeks in the Maintenance Period, as recorded in the subject diary. If there were less than 24 h between the end of 1 migraine event and the start of the next event, these 2 events were considered to belong to 1 migraine attack. There had to be a minimum of 24 h of freedom from headache, pain, and symptoms of migraine between attacks recorded in the subject diary to be considered as more than 1 attack of migraine for statistical analysis.

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 in the Frequency of Migraine Attacks	4 weeks		number of migraine attacks/participant	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Value	Spread	Units
Absolute Change From Baseline in the Frequency of Migraine Attacks	Placebo	-0.8	Standard Error 0.1429	number of migraine attacks/participant
Absolute Change From Baseline in the Frequency of Migraine Attacks	ESL 800 mg	-1.0	Standard Error 0.1428	number of migraine attacks/participant
Absolute Change From Baseline in the Frequency of Migraine Attacks	ESL 1200 mg	-1.0	Standard Error 0.1416	number of migraine attacks/participant

Source ClinicalTrials.gov

Participant flow21

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	136
Overall Study	STARTED	ESL 800 mg	135
Overall Study	STARTED	ESL 1200 mg	139
Overall Study	Randomized and Treated	Placebo	136
Overall Study	Randomized and Treated	ESL 800 mg	135
Overall Study	Randomized and Treated	ESL 1200 mg	139
Overall Study	Completed Tutration Period	Placebo	130
Overall Study	Completed Tutration Period	ESL 800 mg	134
Overall Study	Completed Tutration Period	ESL 1200 mg	131
Overall Study	Entered Maintenance Period	Placebo	129

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events81

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	Dizziness	Nervous system disorders	Placebo	2	136	2
other	Dizziness	Nervous system disorders	ESL 800 mg	6	135	6
other	Dizziness	Nervous system disorders	ESL 1200 mg	14	139	14
other	Somnolence	Nervous system disorders	Placebo	1	136	1
other	Somnolence	Nervous system disorders	ESL 800 mg	9	135	9
other	Somnolence	Nervous system disorders	ESL 1200 mg	13	139	13
other	Vertigo	Ear and labyrinth disorders	Placebo	4	136	4
other	Vertigo	Ear and labyrinth disorders	ESL 800 mg	4	135	4
other	Vertigo	Ear and labyrinth disorders	ESL 1200 mg	11	139	11
other	Nausea	Gastrointestinal disorders	Placebo	4	136	4

1 to 10 of 81Source ClinicalTrials.gov

See all 81 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	ESL 800 mg
Total, all-cause mortality	ESL 1200 mg
Total, other adverse events	Placebo	46	136
Total, other adverse events	ESL 800 mg	67	135
Total, other adverse events	ESL 1200 mg	74	139
Total, serious adverse events	Placebo	1	136
Total, serious adverse events	ESL 800 mg	1	135
Total, serious adverse events	ESL 1200 mg	4	139

Source ClinicalTrials.gov

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/NCT01820559

GET https://conductscience.org/api/trials/v1/NCT01820559/flow?page=2

API reference For AI assistants