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

NCT01530022 | Completed Phase 1

• 1 other identifier: SP0998
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

Lacosamide; Vimpat; Cognition; Mental Processes; Adverse Effects

Outcome Measures

Primary Outcomes (1)

• Mean Within-subject Difference In The Overall Neuropsychological Composite Score During Both Treatment Periods

  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)

Study Arms (2)

LCM 300 mg/CBZ-IR 600 mg

OTHER

Crossover sequence of experimental treatment and active comparator

Drug: Lacosamide (LCM); Drug: Carbamazepine Immediate Release (CBZ-IR)

CBZ-IR 600 mg/LCM 300 mg

OTHER

Crossover sequence of active comparator and experimental treatment

Drug: Lacosamide (LCM); Drug: Carbamazepine Immediate Release (CBZ-IR)

Interventions

Lacosamide (LCM) DRUG

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

Also known as: Vimpat

CBZ-IR 600 mg/LCM 300 mg; LCM 300 mg/CBZ-IR 600 mg

Carbamazepine Immediate Release (CBZ-IR) DRUG

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.

Also known as: Tegretol IR

CBZ-IR 600 mg/LCM 300 mg; LCM 300 mg/CBZ-IR 600 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (2)

001

Atlanta, Georgia, United States

Location

002

Overland Park, Kansas, United States

Location

Related Publications (1)

• 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.

  PMID: 27517350 DERIVED

MeSH Terms

Interventions

Lacosamide; Carbamazepine

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• UCB Clinical Trial Call Center

  877-822-9493

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 9, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

US (2)