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

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: BIA 2-093

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• Body mass index (BMI) was within the range of 18 to 30 kg/m2, inclusive, with a minimum weight of at least 50 kg
• Free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead ECG, and laboratory evaluation at Screening.
• Female subjects of childbearing potential practiced abstinence or used and were willing to continue to use a medically acceptable form of birth control for at least 1 month prior to Screening and for at least 1 month after the last study drug administration. Medically acceptable forms of contraception included intrauterine device or double-barrier. Hormone-based contraceptives methods were not acceptable, because ESL may have decreased their effectiveness. Female subjects of non-childbearing potential were amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.
• Male subjects were required to use a double-barrier form of contraception
• Subjects who were willing and able to abide by all study requirements and restrictions

Exclusion Criteria:

• 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
• Use of a non-prescription drug within 7 days prior to the first study drug administration. Unless in the opinion of the investigator or designee, the medication received did not interfere with the study procedures or data integrity or compromise the safety of the subject
• Use of any prescription medications or natural health products (except acceptable forms of birth control and hormone replacement) within 14 days prior to the first study drug administration or throughout the study, unless in the opinion of the investigator or designee, the product did not interfere with the study procedures or data integrity or compromise the safety of the subject
• Positive serum pregnancy screen following Screening or positive urine pregnancy screen at admission and on Days -1, 9, or 16
• Positive urine drug screen (5-panel MedTox kit) at Screening, Day -1, Day 9, or Day 16.
• Positive breath alcohol test at Screening, Days -1, 9, or 16
• Female subjects who were pregnant or lactating or who were planning to become pregnant within 60 days of last study drug administration
• History of allergy or hypersensitivity to ESL, related drugs, or any of the drug excipients or other drug product components
• Positive for Hepatitis B, Hepatitis C, or HIV
• Current or pending legal charges
• Treatment with any investigational drug within 30 days prior to first drug administration
• A subject who, in the opinion of the investigator or designee, was not considered to be suitable and was unlikely to comply with the study protocol for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 BIA 2-093; A single dose of oral ESL 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.	Drug: BIA 2-093; Other Names: ESL, Eslicarbazepine acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Motor Reaction Time (MRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase	-1, 3, 6, and 10 hours post-dose
Motor Reaction Time (MRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase	-1, 3, 6, and 10 hours post-dose
Recognition Reaction Time (RRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase	-1, 3, 6, and 10 hours post-dose
Recognition Reaction Time (RRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase	-1, 3, 6, and 10 hours post-dose
Total Reaction Time (TRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase	-1, 3, 6, and 10 hours post-dose
Total Reaction Time (TRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase	-1, 3, 6, and 10 hours post-dose

Collaborators and Investigators

• Sponsor: Bial - Portela C S.A.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: November 4, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 6, 2014

Study Record Updates

• Last Update Posted (Estimate): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Eslicarbazepine acetate
• Other Study ID Numbers: BIA-2093-123