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

NCT ID: NCT01530022

Last Updated: 2014-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-01-31

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

LCM 300 mg/CBZ-IR 600 mg

Crossover sequence of experimental treatment and active comparator

Group Type: OTHER

Lacosamide (LCM)

Intervention Type: 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

Carbamazepine Immediate Release (CBZ-IR)

Intervention Type: 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.

CBZ-IR 600 mg/LCM 300 mg

Crossover sequence of active comparator and experimental treatment

Group Type: OTHER

Lacosamide (LCM)

Intervention Type: 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

Carbamazepine Immediate Release (CBZ-IR)

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Vimpat; Tegretol IR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

877-822-9493

Locations

001

Atlanta, Georgia, United States

002

Overland Park, Kansas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27517350 (View on PubMed)

Other Identifiers

SP0998

Identifier Type: -

Identifier Source: org_study_id