NCT01530022

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-02-09
• Last updated: 2014-01-24

Locations

2 sites across 1 country: United States