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

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ClinicalTrials.gov Identifier: NCT01820559
Recruitment Status : Completed
First Posted : March 29, 2013
Results First Posted : May 24, 2013
Last Update Posted : May 24, 2013
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: Placebo
Drug: ESL 1200 mg
Drug: ESL 800 mg
Enrollment 452
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo ESL 800 mg ESL 1200 mg
Hide Arm/Group Description

Placebo tablets

Placebo : Tablets

eslicarbazepine acetate 800 mg

ESL 800 mg :

eslicarbazepine acetate 1200 mg

ESL 1200 mg :

Period Title: Overall Study
Started 136 135 139
Randomized and Treated 136 135 139
Completed Tutration Period 130 134 131
Entered Maintenance Period 129 133 129
Completed Maintenance Period 122 123 110
Completed 122 122 110
Not Completed 14 13 29
Reason Not Completed
Adverse Event             4             6             13
Withdrawal by Subject             1             2             5
Protocol Violation             2             1             3
Subject's non-compliance             1             0             2
Lost to Follow-up             3             2             2
At sponsor request             0             0             1
Lack of Efficacy             3             2             3
Arm/Group Title Placebo ESL 800 mg ESL 1200 mg Total
Hide Arm/Group Description

Placebo tablets

Placebo : Tablets

eslicarbazepine acetate 800 mg

ESL 800 mg :

eslicarbazepine acetate 1200 mg

ESL 1200 mg :

Total of all reporting groups
Overall Number of Baseline Participants 136 135 139 410
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 136 participants 135 participants 139 participants 410 participants
<=65 years 135 135 136 406
>65 years 1 0 3 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 135 participants 139 participants 410 participants
Female
121
  89.0%
114
  84.4%
111
  79.9%
346
  84.4%
Male
15
  11.0%
21
  15.6%
28
  20.1%
64
  15.6%
1.Primary Outcome
Title Absolute Change From Baseline in the Frequency of Migraine Attacks
Hide Description The primary efficacy variable was the absolute change from baseline in the frequency of migraine attacks standardised to 4 weeks in the Maintenance Period, as recorded in the subject diary. If there were less than 24 h between the end of 1 migraine event and the start of the next event, these 2 events were considered to belong to 1 migraine attack. There had to be a minimum of 24 h of freedom from headache, pain, and symptoms of migraine between attacks recorded in the subject diary to be considered as more than 1 attack of migraine for statistical analysis.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo ESL 800 mg ESL 1200 mg
Hide Arm/Group Description:

Placebo tablets

Placebo : Tablets

eslicarbazepine acetate 800 mg

ESL 800 mg :

eslicarbazepine acetate 1200 mg

ESL 1200 mg :

Overall Number of Participants Analyzed 133 134 136
Least Squares Mean (Standard Error)
Unit of Measure: number of migraine attacks/participant
-0.8  (0.1429) -1.0  (0.1428) -1.0  (0.1416)
Time Frame Treatment-emergent adverse events(TEAEs) were evaluated throughout the study TEAEs, i.e. those Adverse Events (AEs) starting after the first dose intake until 28 days after the last dose, have been summarised by SOC and PT
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo ESL 800 mg ESL 1200 mg
Hide Arm/Group Description

Placebo tablets

Placebo : Tablets

eslicarbazepine acetate 800 mg

ESL 800 mg :

eslicarbazepine acetate 1200 mg

ESL 1200 mg :

All-Cause Mortality
Placebo ESL 800 mg ESL 1200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo ESL 800 mg ESL 1200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/136 (0.74%)      1/135 (0.74%)      4/139 (2.88%)    
Cardiac disorders       
VENTRICULAR ARRHYTHMIA  1  0/136 (0.00%)  0 0/135 (0.00%)  0 1/139 (0.72%)  1
Infections and infestations       
VIRAL INFECTION  1  1/136 (0.74%)  1 0/135 (0.00%)  0 1/139 (0.72%)  1
Nervous system disorders       
STATUS MIGRAINOSUS  1  0/136 (0.00%)  0 1/135 (0.74%)  1 1/139 (0.72%)  1
Psychiatric disorders       
ADJUSTMENT DISORDER  1  0/136 (0.00%)  0 0/135 (0.00%)  0 1/139 (0.72%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo ESL 800 mg ESL 1200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/136 (33.82%)      67/135 (49.63%)      74/139 (53.24%)    
Ear and labyrinth disorders       
Vertigo  1  4/136 (2.94%)  4 4/135 (2.96%)  4 11/139 (7.91%)  11
Endocrine disorders       
Hypothyroidism  1  2/136 (1.47%)  2 3/135 (2.22%)  3 2/139 (1.44%)  2
Gastrointestinal disorders       
Nausea  1  4/136 (2.94%)  4 6/135 (4.44%)  6 10/139 (7.19%)  10
Vomiting  1  3/136 (2.21%)  3 2/135 (1.48%)  2 3/139 (2.16%)  3
Dyspepsia  1  0/136 (0.00%)  0 1/135 (0.74%)  1 3/139 (2.16%)  3
Abdominal pain upper  1  3/136 (2.21%)  3 3/135 (2.22%)  3 2/139 (1.44%)  2
General disorders       
Fatigue  1  1/136 (0.74%)  1 4/135 (2.96%)  4 3/139 (2.16%)  3
Influenza  1  2/136 (1.47%)  2 3/135 (2.22%)  3 3/139 (2.16%)  3
Asthenia  1  0/136 (0.00%)  0 2/135 (1.48%)  2 3/139 (2.16%)  3
Face oedema  1  0/136 (0.00%)  0 0/135 (0.00%)  0 3/139 (2.16%)  3
Infections and infestations       
Nasopharyngitis  1  6/136 (4.41%)  6 5/135 (3.70%)  5 4/139 (2.88%)  4
Upper respiratory tract infection  1  1/136 (0.74%)  1 3/135 (2.22%)  3 1/139 (0.72%)  1
Respiratory tract infection  1  0/136 (0.00%)  0 3/135 (2.22%)  3 0/139 (0.00%)  0
Investigations       
Blood creatine phosphokinase increased  1  2/136 (1.47%)  2 3/135 (2.22%)  3 1/139 (0.72%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  1  4/136 (2.94%)  4 0/135 (0.00%)  0 0/139 (0.00%)  0
Back pain  1  3/136 (2.21%)  3 1/135 (0.74%)  1 0/139 (0.00%)  0
Nervous system disorders       
Dizziness  1  2/136 (1.47%)  2 6/135 (4.44%)  6 14/139 (10.07%)  14
Somnolence  1  1/136 (0.74%)  1 9/135 (6.67%)  9 13/139 (9.35%)  13
Migraine  1  3/136 (2.21%)  3 2/135 (1.48%)  2 6/139 (4.32%)  6
Tension headache  1  1/136 (0.74%)  1 1/135 (0.74%)  1 3/139 (2.16%)  3
Status migrainosus  1  0/136 (0.00%)  0 2/135 (1.48%)  2 3/139 (2.16%)  3
Insomnia  1  3/136 (2.21%)  3 1/135 (0.74%)  1 1/139 (0.72%)  1
Vascular disorders       
Hypertension  1  1/136 (0.74%)  1 3/135 (2.22%)  3 1/139 (0.72%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Head of Clinical Research Section
Organization: BIAL - Portela & Ca, SA
Phone: 351 22 986 6100
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01820559     History of Changes
Other Study ID Numbers: BIA-2093-209
First Submitted: March 26, 2013
First Posted: March 29, 2013
Results First Submitted: April 5, 2013
Results First Posted: May 24, 2013
Last Update Posted: May 24, 2013