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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01530022
First received: February 6, 2012
Last updated: January 23, 2014
Last verified: January 2014

February 6, 2012
January 23, 2014
May 2012
January 2014   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01530022 on ClinicalTrials.gov Archive Site
Not Provided
  • Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During Both Treatment Periods [ Time Frame: From 6-week Treatment Period 1 through 6-week Treatment Period 2 (Visit 1- Visit 9) ] [ Designated as safety issue: No ]
  • Number of Subjects Experiencing the Occurrence of at least one Serious Adverse Event (SAE) During Both Treatment Periods [ Time Frame: From 6-week Treatment Period 1 through 6-week Treatment Period 2 (Visit 1- Visit 9) ] [ Designated as safety issue: No ]

    A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

    • Is fatal
    • Is life-threatening
    • Results in persistent or significant disability/incapacity
    • Requires inpatient hospitalization
    • Prolongs existing inpatient hospitalization
    • Is a congenital anomaly/birth defect
    • Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above.
Not Provided
Not Provided
 
Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects
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.

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).

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Healthy
  • 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 Name: 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 Name: Tegretol IR
  • LCM 300 mg/CBZ-IR 600 mg
    Crossover sequence of experimental treatment and active comparator
    Interventions:
    • Drug: Lacosamide (LCM)
    • Drug: Carbamazepine Immediate Release (CBZ-IR)
  • CBZ-IR 600 mg/LCM 300 mg
    Crossover sequence of active comparator and experimental treatment
    Interventions:
    • Drug: Lacosamide (LCM)
    • Drug: Carbamazepine Immediate Release (CBZ-IR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01530022
SP0998
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center 877-822-9493
UCB Pharma
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP