Clinical trial NCT01530022: Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects
Official title: A Multicenter, Randomized, Double-blind, Double-dummy, 2-period Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Lacosamide
Vimpat
Cognition
Mental Processes
Adverse Effects
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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).

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

Primary outcomes:
measure: Mean Within-subject Difference In The Overall Neuropsychological Composite Score During Both Treatment Periods
timeFrame: From 6-week Treatment Period 1 to 6-week Treatment Period 2 (Visit 1- Visit 9)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: 001
state: Georgia
city: Overland Park
country: United States
facility: 002
state: Kansas
Study officials:
affiliation: 877-822-9493
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.