Overview

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

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bial - Portela C S.A.
Treatments:
Eslicarbazepine acetate
Criteria
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.

- A history of chronic alcohol or drug abuse or addiction within the last 2 years.

- A severe hepatic, renal, respiratory, haematological, 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.

- 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 medical
device).

- 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.