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Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine: a Doubleblind,Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial

NCT01820559•Bial - Portela C S.A.

View on ClinicalTrials.gov

Summary

This was a multinational, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of multiple doses of ESL as prophylactic treatment in subjects with migraine with or without aura. Subjects were randomised in a 1:1:1 ratio to receive placebo, ESL 800 mg/day once daily (QD), or ESL 1200 mg/day QD.

Detailed Description

The study consisted of a Screening Period of 2 to 4 weeks, a 4-week placebo Baseline Period, a 2-week Titration Period, a 12-week Maintenance Period, and a 4-week Follow-up Period. During the entire study the subjects had a diary to document the occurrence, duration, and intensity of headaches, the occurrence or not of aura and its nature, as well as other related symptoms, and the use of study medication and acute medication.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Women or men, 18 years of age or older (according to Amendment #1 for Czech Republic \[24 Mar 2009\]: 18 to 65 years of age).
•Diagnosis (established prior to 50 years of age) of migraine headaches for at least 1 year, and a well-documented history of migraine headaches with or without aura according to the criteria of the IHS (see Section 3.5.6.1) for at least 3 months (according to Amendment #1 for Czech Republic \[24 Mar 2009\]: for at least 3 months with at least 3 migraine attacks per month in each of these 3 months).
•At least 2 (according to Amendment #1 for Czech Republic \[24 Mar 2009\]: at least 3) (and no more than 10) well-defined migraine headache attacks per month, with at least 24 h of freedom from headaches and other symptoms of migraine between attacks.
•Able to distinguish the migraine headache attacks from other types of common headaches (tension-type headaches, sinus-related headaches, etc.).
•Not taking any prophylactic migraine therapies for at least 2 weeks prior to Baseline Visit (V2). Flunarizine had to be discontinued at least 4 weeks prior to V2.
•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 (ICF).
•Able and willing to comply with all study requirements, in the judgment of the investigator.
•Women were surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or at least 2 years postmenopausal or, if of childbearing potential, were sexually abstinent or agreed to use medically acceptable non-hormonal methods of contraception (see Section 3.3.3). (According to Amendment #1 for Czech Republic \[24 Mar 2009\]: Women were sexually abstinent or agreed to use a double-barrier method of contraception. Hormonal contraceptives were not acceptable as a contraceptive method in this study. However, their intake was not forbidden throughout the study.)

Exclusion Criteria

•A known hypersensitivity to ESL or to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine), or to any of the excipients.
•Suspected or confirmed medication-overuse headache.
•More than 14 headache days (migraine or other headache types) per month in either of the 2 months prior to screening.
•Consistent or recurrent frequent headaches (i.e. ≥6 headache days a month) other than migraine headaches.
•Unable to discontinue medications primarily used for migraine prophylaxis that have been commonly used for other indications (tricyclic agents, divalproic acid, topiramate, etc.). A subject who received beta blockers or calcium channel blocker therapy for reasons other than migraine prophylaxis was eligible for inclusion, provided his/her dosing regimen had been stable for ≥2 months and was not expected to change during the course of the study.
•Using prohibited concomitant medication (see Section 3.5.5.2).
•A white blood cell (WBC) count \<2.5 \* 109/L, neutrophil count \<1.5 \* 109/L, sodium \<125 mmol/L, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times 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.
•A creatinine clearance lower than 60 mL/min at screening.
•A second- or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator.
•Pregnant or nursing women.
+4 more criteria

Key Dates

Start Date

April 1, 2009

Primary Completion Date

June 1, 2010

Completion Date

June 1, 2010

Last Updated

May 24, 2013

Enrollment

452

ACTUAL participants

Conditions

Migraine

Interventions

Placebo

DRUG

ESL 1200 mg

DRUG

ESL 800 mg

DRUG

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

NCT07018713

Chronic Migraine

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RECRUITINGPHASE3

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

NCT06641466

Menstrual Migraine

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RECRUITINGNA

Mind Body Balance for Pediatric Migraine

NCT04715685

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.