Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects

UCB

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Lacosamide (LCM)

Drug: Carbamazepine Immediate Release (CBZ-IR)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01530022

SP0998

Details and patient eligibility

About

The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also be collected.

Full description

Approximately 50 subjects at multiple sites will crossover to receive both treatments (lacosamide [LCM]and carbamazepine immediate release [CBZ-IR]) in a randomized order during the 2 study treatment periods (Treatment Period 1 and Treatment Period 2).

A Screening Visit will be conducted to evaluate subject eligibility for enrollment into the study. Eligible subjects will return up to 21 days after the Screening Visit and begin Treatment Period 1. During Visit 2, eligible subjects will be randomized to receive either LCM 300 mg/day or CBZ-IR 600 mg/day. Subjects will be treated with their first randomized Antiepileptic Drug (AED) for 6 weeks (Titration Period [21 days] and Maintenance Period [21 days]). Subjects then complete a 28-day Taper/Washout Period, during which their first AED will be tapered over 4 days followed by a 24-day Washout Period, where subjects will receive no AED. Upon completion of the Taper/Washout Period, subjects will begin Treatment Period 2.The procedures and assessments for Treatment Period 1 will be repeated for Treatment Period 2 (with the same duration of treatment).

Enrollment

60 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects are between 18 and 55 years of age (inclusive)
Subjects have a Body Mass Index (BMI) between 18 and 35 kg/m^2 (inclusive)
Subjects must be in generally good health with no clinically relevant health conditions

Exclusion criteria

Subject has previously been randomized in this study or subject has received LCM or CBZ
Subjects may not currently be participating in or have participated in the past 30 days in a clinical drug or device study
Subjects may not have a history of drug or alcohol abuse within the last 2 years
Subjects may not consume more than 40 g of alcohol per day
Females who are pregnant or nursing are ineligible; females of childbearing potential must agree to adhere to protocol conception guidelines
Subjects may not score ≤ 70 on the Peabody Picture Vocabulary Test (PPVT)
Subjects with a lifetime history of suicide attempt or suicidal ideation in the past 6 months may not participate
Subjects with a diet that deviates notably from the normal amounts of protein, carbohydrate, and fat, as judged by the investigator are ineligible to participate
Subjects may not consume more than 600 mg of caffeine/day
Subjects may not smoke more than 10 cigarettes per day or have done so within 6 months prior to Screening
Subjects may not have a positive alcohol breath test or urine drug screen at Screening