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

January 23, 2014 updated by: UCB Pharma

A Multicenter, Randomized, Double-blind, Double-dummy, 2-period Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States
        • 001
    • Kansas
      • Overland Park, Kansas, United States
        • 002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: LCM 300 mg/CBZ-IR 600 mg
Crossover sequence of experimental treatment and active comparator
Drug: Lacosamide (LCM)

LCM 300 mg:

LCM 50 mg and LCM 100 mg white, film-coated oral tablets and Carbamazepine Immediate Release (CBZ-IR) matching placebo capsules.

Two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases.

Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period

Other Names:
  • Vimpat
Drug: Carbamazepine Immediate Release (CBZ-IR)

CBZ-IR 600 mg:

CBZ-IR 200 mg oral tablets over-encapsulated to double-blind capsules with an overfill.

LCM matching placebo tablets two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases.

Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period.

Other Names:
  • Tegretol IR
OTHER: CBZ-IR 600 mg/LCM 300 mg
Crossover sequence of active comparator and experimental treatment
Drug: Lacosamide (LCM)

LCM 300 mg:

LCM 50 mg and LCM 100 mg white, film-coated oral tablets and Carbamazepine Immediate Release (CBZ-IR) matching placebo capsules.

Two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases.

Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period

Other Names:
  • Vimpat
Drug: Carbamazepine Immediate Release (CBZ-IR)

CBZ-IR 600 mg:

CBZ-IR 200 mg oral tablets over-encapsulated to double-blind capsules with an overfill.

LCM matching placebo tablets two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases.

Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period.

Other Names:
  • Tegretol IR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Within-subject Difference In The Overall Neuropsychological Composite Score During Both Treatment Periods
Time Frame: From 6-week Treatment Period 1 to 6-week Treatment Period 2 (Visit 1- Visit 9)
The overall composite score will be computed as the sum of the individual cognitive test scores from computerized tests and non-computerized neuropsychological tests (including behavioral questionnaires) after transformation to a Z-scores to form an overall composite Z-score. The Z-score will be calculated using the values (mean and standard deviation) from the average of the scores from 3 non-drug conditions (Baseline, first Washout Period, and second Washout Period).
From 6-week Treatment Period 1 to 6-week Treatment Period 2 (Visit 1- Visit 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (ESTIMATE)

February 9, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0998

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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