Efficacy and safety of Eslicarbazepine acetate as preventive therapy for patients with migraine: a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial

INTERVENTION: Product Name: ESLICARBAZEPINE ACETATE Product Code: BIA 2‐093 Pharmaceutical Form: Tablet INN or Proposed INN: ESLICARBAZEPINE ACETATE CAS Number: 236395‐14‐5 Current Sponsor code: BIA 2‐093 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: ESLICARBAZEPINE ACETATE Product Code: BIA 2‐093 Pharmaceutical Form: Tablet INN or Proposed INN: ESLICARBAZEPINE ACETATE CAS Number: 236395‐14‐5 Current Sponsor code: BIA 2‐093 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: MIGRAINE ; MedDRA version: 12.0 Level: LLT Classification code 10027599 Term: Migraine PRIMARY OUTCOME: Main Objective: The primary objective of this study is to assess the efficacy of ESL as preventive therapy for patients with migraine with and without aura. 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. Secondary Objective: The secondary objective of this study is to assess the safety and tolerability of ESL in patients with migraine. INCLUSION CRITERIA: To be eligible for enrolment in this study the patients must fulfil ALL the following 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