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Efficacy and Safety of Eslicarbazepine Acetate as Therapy in Subjects With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01820585
Recruitment Status : Completed
First Posted : March 29, 2013
Results First Posted : July 19, 2013
Last Update Posted : July 19, 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 Fibromyalgia
Interventions Drug: Placebo
Drug: ESL 400 mg
Drug: ESL 800 mg
Drug: ESL 1200 mg
Enrollment 528
Recruitment Details

Subjects were screened in 84 centres in 16 European countries (Austria, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Ukraine and United Kingdom).

Study initiation date: 21 Apr 2009 Study completion date: 03 Sep 2010;

Pre-assignment Details After completing procedures at V1, subjects returned to the study centre for V2. At V2, subjects, who had completed at least 4 subject diary pain assessments satisfactorily within the past 7 days, had an average pain score that was ≥4 and ≤9 and continued to meet all study entry criteria, were randomly assigned to 1 of the 4 treatment groups.
Arm/Group Title Placebo ESL 400 mg ESL 800 mg ESL 1200 mg
Hide Arm/Group Description Placebo tablets matching the 400-mg and 600-mg tablets were administered Once daily (QD) by oral route. Eslicarbazepine acetate (ESL) 400 mg : ESL was supplied in 400-mg tablets and was administered QD by oral route. ESL 800 mg : ESL was supplied in 400-mg tablets and was administered QD by oral route ESL was supplied in 400-mg and 600-mg tablets and was administered QD by oral route.
Period Title: Overall Study
Started 131 130 135 132
Randomized and Treated 131 130 135 132
Full Analysis Set 131 130 135 129
Completed Titration Period 128 125 131 126
Entered Maintenance Period 128 124 131 123
Completed Maintenance Period 105 98 101 84
Completed 104 98 101 83
Not Completed 27 32 34 49
Reason Not Completed
Adverse Event             9             13             23             34
Lack of Efficacy             9             7             5             1
Withdrawal by Subject             3             7             3             8
Lost to Follow-up             3             3             0             3
Protocol Violation             3             1             1             1
Subject non-compliance             0             0             1             2
at sponsor request             0             0             1             0
Pregnancy             0             1             0             0
Arm/Group Title Placebo ESL 400 mg ESL 800 mg ESL 1200 mg Total
Hide Arm/Group Description

Tablets

Placebo : Tablets

Eslicarbazepine acetate (BIA 2-093) tablets

ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets

Eslicarbazepine acetate (BIA 2-093) tablets

ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets

Eslicarbazepine acetate (BIA 2-093) tablets

ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets

Total of all reporting groups
Overall Number of Baseline Participants 131 130 135 132 528
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 131 participants 130 participants 135 participants 132 participants 528 participants
<=65 Years 126 126 132 127 511
>65 years 5 4 3 5 17
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 130 participants 135 participants 132 participants 528 participants
Female
124
  94.7%
114
  87.7%
127
  94.1%
122
  92.4%
487
  92.2%
Male
7
   5.3%
16
  12.3%
8
   5.9%
10
   7.6%
41
   7.8%
1.Primary Outcome
Title Absolute Change From Baseline to Endpoint in Mean Pain
Hide Description The primary efficacy variable was the absolute change from baseline to endpoint in mean pain. Pain intensity was assessed on an 11-point (0-10) Numeric pain rating scale (NPRS), where 0 = no pain and 10 = worst possible pain and was recorded in a subject's diary. The subject was instructed to complete the assessment daily on awakening.Primary analyses were conducted on the full analysis set (FAS) which consisted of all randomised subjects who received at least 1 dose of study medication and with at least 1 post-randomisation rating of 24-h-average pain. The primary efficacy variable was the absolute change from baseline to endpoint in mean pain recorded in a subject's diary upon awakening each morning. An ANCOVA on the FAS revealed no statistically significant differences between the 3 ESL groups and the placebo group after 13 weeks of treatment.
Time Frame Baseline and 13 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo ESL 400 mg ESL 800 mg ESL 1200 mg
Hide Arm/Group Description:

Tablets

Placebo : Tablets

Eslicarbazepine acetate (BIA 2-093) tablets

ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets

Eslicarbazepine acetate (BIA 2-093) tablets

ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets

Eslicarbazepine acetate (BIA 2-093) tablets

ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets

Overall Number of Participants Analyzed 130 130 135 129
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.0  (0.1735) -0.8  (0.1731) -1.2  (0.1704) -0.8  (0.1734)
Time Frame Adverse events (AEs) were evaluated throughout the study that consisted of a 2-week Baseline Period, a 1-week Titration Period (active treatment or placebo) and a 12- week Maintenance Period (active treatment or placebo).
Adverse Event Reporting Description Safety was evaluated based on adverse events (AEs)
 
Arm/Group Title Placebo ESL 400 mg ESL 800 mg ESL 1200 mg
Hide Arm/Group Description

Tablets

Placebo : Tablets

Eslicarbazepine acetate (BIA 2-093) tablets

ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets

Eslicarbazepine acetate (BIA 2-093) tablets

ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets

Eslicarbazepine acetate (BIA 2-093) tablets

ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets

All-Cause Mortality
Placebo ESL 400 mg ESL 800 mg ESL 1200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo ESL 400 mg ESL 800 mg ESL 1200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/131 (2.29%)      5/130 (3.85%)      6/135 (4.44%)      1/132 (0.76%)    
Gastrointestinal disorders         
Abdominal pain  1  0/131 (0.00%)  0 1/130 (0.77%)  1 0/135 (0.00%)  0 0/132 (0.00%)  0
Inguinal hernia  1  0/131 (0.00%)  0 1/130 (0.77%)  1 0/135 (0.00%)  0 0/132 (0.00%)  0
Infections and infestations         
Gastroenteritis  1  0/131 (0.00%)  0 1/130 (0.77%)  1 0/135 (0.00%)  0 0/132 (0.00%)  0
Injury, poisoning and procedural complications         
Arthropod bite  1  0/131 (0.00%)  0 0/130 (0.00%)  0 1/135 (0.74%)  1 0/132 (0.00%)  0
Fall  1  0/131 (0.00%)  0 0/130 (0.00%)  0 0/135 (0.00%)  0 1/132 (0.76%)  1
Incisional hernia  1  1/131 (0.76%)  1 0/130 (0.00%)  0 0/135 (0.00%)  0 0/132 (0.00%)  0
Multiple injuries  1  1/131 (0.76%)  1 0/130 (0.00%)  0 0/135 (0.00%)  0 0/132 (0.00%)  0
Investigations         
Blood creatine phosphokinase increased  1  0/131 (0.00%)  0 1/130 (0.77%)  1 0/135 (0.00%)  0 0/132 (0.00%)  0
Metabolism and nutrition disorders         
Hyponatraemia  1  0/131 (0.00%)  0 0/130 (0.00%)  0 1/135 (0.74%)  1 0/132 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  0/131 (0.00%)  0 0/130 (0.00%)  0 1/135 (0.74%)  1 0/132 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer in situ  1  0/131 (0.00%)  0 0/130 (0.00%)  0 1/135 (0.74%)  1 0/132 (0.00%)  0
Nervous system disorders         
Syncope  1  0/131 (0.00%)  0 0/130 (0.00%)  0 1/135 (0.74%)  1 0/132 (0.00%)  0
Psychiatric disorders         
Completed suicide  1  0/131 (0.00%)  0 0/130 (0.00%)  0 1/135 (0.74%)  1 0/132 (0.00%)  0
Suicidal ideation  1  1/131 (0.76%)  1 0/130 (0.00%)  0 0/135 (0.00%)  0 0/132 (0.00%)  0
Surgical and medical procedures         
Abortion induced  1  0/131 (0.00%)  0 1/130 (0.77%)  1 0/135 (0.00%)  0 0/132 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo ESL 400 mg ESL 800 mg ESL 1200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   75/131 (57.25%)      86/130 (66.15%)      92/135 (68.15%)      93/132 (70.45%)    
Ear and labyrinth disorders         
Vertigo  1  2/131 (1.53%)  2 2/130 (1.54%)  2 5/135 (3.70%)  5 9/132 (6.82%)  9
Gastrointestinal disorders         
Nausea  1  10/131 (7.63%)  10 10/130 (7.69%)  10 17/135 (12.59%)  17 21/132 (15.91%)  21
Vomiting  1  1/131 (0.76%)  1 5/130 (3.85%)  5 4/135 (2.96%)  4 9/132 (6.82%)  9
Abdominal pain upper  1  7/131 (5.34%)  7 6/130 (4.62%)  6 5/135 (3.70%)  5 8/132 (6.06%)  8
Dyspepsia  1  3/131 (2.29%)  3 3/130 (2.31%)  3 6/135 (4.44%)  6 5/132 (3.79%)  5
Constipation  1  2/131 (1.53%)  2 3/130 (2.31%)  3 4/135 (2.96%)  4 5/132 (3.79%)  5
Abdominal pain  1  4/131 (3.05%)  4 2/130 (1.54%)  2 2/135 (1.48%)  2 3/132 (2.27%)  3
Diarrhoea  1  4/131 (3.05%)  4 2/130 (1.54%)  2 1/135 (0.74%)  1 3/132 (2.27%)  3
General disorders         
Fatigue  1  5/131 (3.82%)  5 5/130 (3.85%)  5 7/135 (5.19%)  7 11/132 (8.33%)  11
Oedema peripheral  1  1/131 (0.76%)  1 2/130 (1.54%)  2 5/135 (3.70%)  5 2/132 (1.52%)  2
Pain  1  3/131 (2.29%)  3 2/130 (1.54%)  2 4/135 (2.96%)  4 1/132 (0.76%)  1
Infections and infestations         
Nasopharyngitis  1  3/131 (2.29%)  3 5/130 (3.85%)  5 14/135 (10.37%)  14 8/132 (6.06%)  8
Investigations         
Gamma-glutamyl transferase increased  1  0/131 (0.00%)  0 6/130 (4.62%)  6 8/135 (5.93%)  8 10/132 (7.58%)  10
Alanine aminotransferase increased  1  1/131 (0.76%)  1 3/130 (2.31%)  3 1/135 (0.74%)  1 4/132 (3.03%)  4
Blood creatine phosphokinase increased  1  1/131 (0.76%)  1 4/130 (3.08%)  4 3/135 (2.22%)  3 1/132 (0.76%)  1
Musculoskeletal and connective tissue disorders         
Fibromyalgia  1  2/131 (1.53%)  2 6/130 (4.62%)  6 3/135 (2.22%)  3 4/132 (3.03%)  4
Back pain  1  2/131 (1.53%)  2 6/130 (4.62%)  6 3/135 (2.22%)  3 4/132 (3.03%)  4
Nervous system disorders         
Headache  1  16/131 (12.21%)  16 18/130 (13.85%)  18 19/135 (14.07%)  19 25/132 (18.94%)  25
Dizziness  1  6/131 (4.58%)  6 7/130 (5.38%)  7 7/135 (5.19%)  7 15/132 (11.36%)  15
Somnolence  1  4/131 (3.05%)  4 3/130 (2.31%)  3 3/135 (2.22%)  3 7/132 (5.30%)  7
Psychiatric disorders         
Insomnia  1  3/131 (2.29%)  3 1/130 (0.77%)  1 3/135 (2.22%)  3 4/132 (3.03%)  4
Skin and subcutaneous tissue disorders         
Rash  1  1/131 (0.76%)  1 2/130 (1.54%)  2 8/135 (5.93%)  8 8/132 (6.06%)  8
Pruritus  1  1/131 (0.76%)  1 6/130 (4.62%)  6 4/135 (2.96%)  4 4/132 (3.03%)  4
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
Layout table for Results Point of Contact information
Name/Title: Head of Clinical Research Section
Organization: Bial - Portela & Cª, S.A.
Phone: + 351 22 986 61 00
EMail: clinical.trials@bial.com
Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01820585    
Other Study ID Numbers: BIA-2093-210
First Submitted: March 26, 2013
First Posted: March 29, 2013
Results First Submitted: April 4, 2013
Results First Posted: July 19, 2013
Last Update Posted: July 19, 2013