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

NCT01530022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-01-24

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · 877-822-9493

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01530022 on ClinicalTrials.gov