Completed
Effects of Eslicarbazepine Acetate (BIA 2-093) on Cognition and Psychomotor Function: Single-blind, Single-centre, Single and Multiple Dose, Fixed-order, Placebocontrolled Trial in Healthy Volunteers
What is being tested
BIA 2-093
Drug
Who is being recruted
Brain Diseases+1
+ Central Nervous System Diseases
+ Epilepsy
From 18 to 45 Years
+24 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: September 2007
Summary
Principal SponsorBial - Portela C S.A.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2007
Actual date on which the first participant was enrolled.Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers. A single dose of oral ESL 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg each given QD. The single dose was chosen to assess the ESL acute response relationship with respect to cognitive and motor skill performance, and the multiple doses were chosen to further characterize the ESL dose response relationship with respect to cognitive and motor skill performance.
Official TitleEffects of Eslicarbazepine Acetate (BIA 2-093) on Cognition and Psychomotor Function: Single-blind, Single-centre, Single and Multiple Dose, Fixed-order, Placebocontrolled Trial in Healthy Volunteers
Principal SponsorBial - Portela C S.A.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
26 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Brain DiseasesCentral Nervous System DiseasesEpilepsyNervous System Diseases
Criteria
9 inclusion criteria required to participate
Healthy male or female subjects, 18 to 45 years of age, inclusive
Having completed at least high school level education (based on personal report)
Native speakers of the English language or having learned English before 12 years of age
Understood and provided written informed consent prior to the initiation of any protocol-specific procedures
Show More Criteria
15 exclusion criteria prevent from participating
History or presence of drug or alcohol dependence (excluding nicotine and caffeine), including subjects who had ever been in a drug rehabilitation program, based on medical history
Clinically significant abnormalities on physical examination, medical history, 12-lead ECG, vital signs, or laboratory values, as judged by the investigator or designee
Current psychiatric illness, except nicotine and caffeine dependence. Subjects with a past history of psychiatric illness were excluded at the discretion of the investigator or designee
History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition, which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalA single dose of oral ESL 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers