Eficacia y seguridad de acetato de eslicarbacepina como terapia preventiva en pacientes con migraña: ensayo clínico multicéntrico, doble ciego, aleatorizado, controlado con placebo y de grupos paralelos.Efficacy and safety of Eslicarbazepine acetate as preventive therapy for patients with migraine: a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial.

Phase 1

• Conditions: Pacientes adultos con migraña con o sin aura. Adult patients with migraine with or without aura; MedDRA version: 9.1Level: LLTClassification code 10027599Term: Migraine

• Registration Number: EUCTR2008-003736-38-ES
• Lead Sponsor: BIAL-Portela & Ca, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-20
• Study Completion: 2010-06-14
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 515

Inclusion Criteria

1. Patient is male or female, aged 18 or older.
2. Patient has a diagnosis (established prior to age 50) 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 International Headache Society (IHS) for at least 3 months.
3. Patient has at least 2 (and no more than 10) well defined migraine headache attacks per month, with at least 24 hours of freedom from headaches and other symptoms of migraine between attacks.
4. Patient is able to distinguish the migraine headache attacks from other types of common headaches (tension type headaches, sinus related headaches, etc).
5. Patient is not taking any prophylactic migraine therapies for at least 2 weeks prior to Baseline Visit (Visit 2). Flunarizine must be discontinued at least 4 weeks prior to Visit 2.
6. Patient is able and willing to provide written informed consent to participate in the study after having the opportunity to review the Patient Information Sheet and Informed Consent Form (ICF).
7. Patient is willing and able to comply with all trial requirements, in the judgement of the investigator.
8. Female patient is surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or at least 2 years postmenopausal or, if of childbearing potential, she is sexually abstinent or agrees to use a medically acceptable non-hormonal method of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient has a known hypersensitivity to ESL or to other carboxamide derivatives (e.g., oxcarbazepine, carbamazepine), or to any of the excipients.
2. Patient with suspected or confirmed medication overuse headaches
3. Patient with more than 14 headache days (migraine or other headache types) per month in any of the 2 months prior to screening.
4. Patient has consistent or recurrent frequent headaches (i.e., ? 6 headache days a month) other than migraine headaches.
5. Patient who is unable to discontinue medications primarily used for migraine prophylaxis that have been commonly used for other indications (tricyclic agents, divalproic acid, topiramate, etc). A patient who receives beta blocker or Ca antagonist therapy for reasons other than migraine prophylaxis may be admitted, provided his/her dosing regimen has been stable for ? 2 months and is not expected to change during the course of the study.
6. Patient is using prohibited concomitant medication.
7. Patient has a white blood cell count (WBC) < 2.5 × 10E9/L, neutrophil count < 1.5 × 10E9/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, can compromise the patient?s safety.
8. Patient has a creatinine clearance lower than 60 mL/min at screening.
9. Patient has 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.
10. Pregnant or nursing women.
11. Patient has a history of chronic alcohol or drug abuse or addiction within the last 2 years.
12. Patient has a severe hepatic, renal, respiratory, haematologic, or immunologic illness, unstable cardiovascular disease, or any other medical or psychiatric condition that, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
13. Patient has received an investigational drug (or a medical device) within 3 months of screening or is currently participating in another trial of an investigational drug (or medical device) trial.
14. Patient is 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 is a family member of the employees or the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate as preventive therapy for patients with migraine with and without aura.;Secondary Objective: The secondary objective of this study is to assess the safety and tolerability of Eslicarbazepine acetate in patients with migraine.;Primary end point(s): The primary efficacy variable is the absolute change from baseline in the frequency of migraine attacks standardised to 4 weeks in the maintenance period. There must be a minimum of 24 hours freedom from headache, pain and symptoms of migraine between migraine attacks recorded in the patient diary to be considered as more than one attack of migraine for statistical analysis.