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Trial record 23 of 89 for:    CARBAMAZEPINE AND Psychotropic

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530022
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : January 24, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE February 6, 2012
First Posted Date  ICMJE February 9, 2012
Last Update Posted Date January 24, 2014
Study Start Date  ICMJE May 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01530022 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
  • 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) ]
  • 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) ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Double-dummy, 2-period Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * Meador KJ, Loring DW, Boyd A, Echauz J, LaRoche S, Velez-Ruiz N, Korb P, Byrnes W, Dilley D, Borghs S, De Backer M, Story T, Dedeken P, Webster E. Randomized double-blind comparison of cognitive and EEG effects of lacosamide and carbamazepine. Epilepsy Behav. 2016 Sep;62:267-75. doi: 10.1016/j.yebeh.2016.07.007. Epub 2016 Aug 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2014)
60
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2012)
50
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01530022
Other Study ID Numbers  ICMJE SP0998
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center 877-822-9493
PRS Account UCB Pharma
Verification Date January 2014

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