Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01530022
- Run by
- UCB Pharma
- People needed
- 60
- Starts
- 2012-05-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2014-01-24
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- 001 — Atlanta, Georgia, United States
- 002 — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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