Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-01 @ 12:57 AM
Study NCT ID:
NCT01820559
Status:
COMPLETED
Last Update Posted:
2013-05-24
First Post:
2013-03-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine
Sponsor:
Bial - Portela C S.A.
Organization:
Study Overview
Official Title:
Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine: a Doubleblind,Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: