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Effects of Eslicarbazepine Acetate (BIA 2-093) on Cognition and Psychomotor Function

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: NCT02284828
Recruitment Status : Completed
First Posted : November 6, 2014
Results First Posted : December 10, 2014
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: BIA 2-093
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 BIA 2-093
Hide Arm/Group Description A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
Period Title: Overall Study
Started 26
Completed 22
Not Completed 4
Arm/Group Title Group 1 BIA 2-093
Hide Arm/Group Description A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
17
  65.4%
Male
9
  34.6%
1.Primary Outcome
Title Motor Reaction Time (MRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
Hide Description [Not Specified]
Time Frame -1, 3, 6, and 10 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 BIA 2-093
Hide Arm/Group Description:
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: miliseconds
3 hours 4.1  (69.22)
6 hours 0.7  (66.37)
10 hours -10.8  (52.96)
2.Primary Outcome
Title Motor Reaction Time (MRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
Hide Description [Not Specified]
Time Frame -1, 3, 6, and 10 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 BIA 2-093
Hide Arm/Group Description:
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: miliseconds
Pre-dose 587.0  (118.51)
3 hours 590.3  (89.91)
6 hours 588.2  (94.12)
10 hours 576.5  (106.46)
3.Primary Outcome
Title Recognition Reaction Time (RRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
Hide Description [Not Specified]
Time Frame -1, 3, 6, and 10 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 BIA 2-093
Hide Arm/Group Description:
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: miliseconds
3 hours -11.1  (55.23)
6 hours -9.2  (54.67)
10 hours -19.3  (51.05)
4.Primary Outcome
Title Recognition Reaction Time (RRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
Hide Description [Not Specified]
Time Frame -1, 3, 6, and 10 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 BIA 2-093
Hide Arm/Group Description:
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: miliseconds
Pre-dose 425.0  (81.88)
3 hours 414.0  (53.55)
6 hours 419.3  (58.70)
10 hours 408.0  (56.40)
5.Primary Outcome
Title Total Reaction Time (TRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
Hide Description [Not Specified]
Time Frame -1, 3, 6, and 10 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 BIA 2-093
Hide Arm/Group Description:
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: miliseconds
Pre-dose 1011.9  (195.12)
3 hours 1004.3  (134.68)
6 hours 1007.5  (145.70)
10 hours 984.5  (157.72)
6.Primary Outcome
Title Total Reaction Time (TRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
Hide Description [Not Specified]
Time Frame -1, 3, 6, and 10 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 BIA 2-093
Hide Arm/Group Description:
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: miliseconds
3 hours -7.0  (119.95)
6 hours -8.4  (117.00)
10 hours -30.0  (99.67)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BIA 2-093 900 mg Placebo BIA 2-093 800 mg BIA 2-093 1200 mg
Hide Arm/Group Description BIA 2-093 - ESL, Eslicarbazepine acetate Placebo, PLC BIA 2-093 - ESL, Eslicarbazepine acetate BIA 2-093 - ESL, Eslicarbazepine acetate
All-Cause Mortality
BIA 2-093 900 mg Placebo BIA 2-093 800 mg BIA 2-093 1200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
BIA 2-093 900 mg Placebo BIA 2-093 800 mg BIA 2-093 1200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/26 (0.00%)   0/26 (0.00%)   0/26 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BIA 2-093 900 mg Placebo BIA 2-093 800 mg BIA 2-093 1200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/26 (34.62%)   13/26 (50.00%)   6/26 (23.08%)   7/26 (26.92%) 
Eye disorders         
Erythema of eyelid  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%)  0/26 (0.00%) 
Vision blurred  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%) 
Gastrointestinal disorders         
Abdominal pain upper  0/26 (0.00%)  2/26 (7.69%)  0/26 (0.00%)  0/26 (0.00%) 
Nausea  2/26 (7.69%)  5/26 (19.23%)  3/26 (11.54%)  0/26 (0.00%) 
Abdominal distension  1/26 (3.85%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Constipation  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Dry mouth  0/26 (0.00%)  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%) 
Epigastric discomfort  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Stomach discomfort  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%)  0/26 (0.00%) 
General disorders         
Asthenia  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Chest discomfort  0/26 (0.00%)  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%) 
Fatigue  1/26 (3.85%)  1/26 (3.85%)  0/26 (0.00%)  1/26 (3.85%) 
Musculoskeletal and connective tissue disorders         
Muscle twitching  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%) 
Sensation of heaviness  0/26 (0.00%)  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%) 
Nervous system disorders         
Headache  1/26 (3.85%)  1/26 (3.85%)  2/26 (7.69%)  2/26 (7.69%) 
Hypoaesthesia  0/26 (0.00%)  0/26 (0.00%)  0/26 (0.00%)  2/26 (7.69%) 
Paraesthesia  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  2/26 (7.69%) 
Somnolence  2/26 (7.69%)  3/26 (11.54%)  0/26 (0.00%)  2/26 (7.69%) 
Dizziness  0/26 (0.00%)  1/26 (3.85%)  2/26 (7.69%)  1/26 (3.85%) 
Dysgeusia  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%) 
Memory impairment  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%) 
Psychomotor hyperactivity  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Tremor  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%) 
Psychiatric disorders         
Anxiety  1/26 (3.85%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Insomnia  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Reproductive system and breast disorders         
Dysmenorrhoea  0/26 (0.00%)  1/26 (3.85%)  1/26 (3.85%)  0/26 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Pharyngolaryngeal pain  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  1/26 (3.85%) 
Skin and subcutaneous tissue disorders         
Pain of skin  0/26 (0.00%)  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%) 
Rash  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Rash maculo-papular  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%) 
1
Term from vocabulary, MedDRA 10.0
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
Organization: Bial – Portela & Cª, S.A.
Phone: +351 229 866 100
EMail: jose.rocha@bial.com
Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02284828    
Other Study ID Numbers: BIA-2093-123
First Submitted: November 4, 2014
First Posted: November 6, 2014
Results First Submitted: December 2, 2014
Results First Posted: December 10, 2014
Last Update Posted: December 10, 2014