A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

The effects of Lacosamide, an antiepileptic drug, on sleep have not been formally evaluated. The present study is being conducted to assess the effects of Lacosamide on sleep quality in healthy subjects.

Key facts

Study ID: NCT01530386
Run by: UCB Pharma
People needed: 25
Starts: 2012-01-01
Expected to finish: 2012-07-01
Last updated by the study team: 2012-08-20

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Reliable and capable subject who signs an IRB approved consent form
Subject is male or female between 18 and 50 years old whose normal Body Mass Index (BMI) is between 18 and 28 kg/m\^2
Subject has no clinically relevant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological or psychiatric abnormalities
Subject is in good health who has good sleep hygiene and normal bed times between 21:00 and 01:00 hours

You may not qualify if…

Subjects who have participated in previous Lacosamide studies or received Lacosamide
Subjects who have received another investigational medication within 30 days or currently participating in an investigational study
Subject has a history of or screening polysomnography that reveals sleep disorders (i.e. sleep apnea or narcolepsy)
Subject consumes more than 400 mg of caffeine per day
Subject has known hypersensitivity to Lacosamide
Subject has alcohol or drug abuse within last 2 years
Subject who consumes more than 40 g of alcohol per day
Subject has a positive alcohol breath test or urine drug screen
Subject smokes more than half a pack of cigarettes per day or consumes nicotine products
Subject is pregnant / nursing or child-bearing potential female not sterile or using contraception methods
Subject is male who does not agree to use contraception
Subjects taking any medications currently or within 2 weeks prior to first dose except non-steroidal anti-inflammatory drugs, oral contraceptives, and non-psychoactive supplements
Subject has elevated live enzymes greater than 2 times the upper limit of normal
Subject has donated blood or had blood loss greater than 400 mL within 3 months prior to first dose
Subject has out of range hematology or chemistry parameters
Subject has clinically relevant abnormality in physical examination or vital signs
Subject has sick sinus syndrome without a pace maker or second or third degree atrioventricular block or clinically significant electrocardiogram finding
Subject has sodium channelopathy
Subject has experienced a myocardial infarction in last 3 months
Subject has New York Heart Association Class III or IV heart failure
Subject has a lifetime history of suicide attempts
Subject has any medical or psychiatric condition
Subject has a known history or severe anaphylactic reaction or serious blood dyscrasias

Where it is running

005 — Little Rock, Arkansas, United States
003 — Cleveland, Ohio, United States
004 — Austin, Texas, United States
001 — Fredericksburg, Virginia, United States

Full record on ClinicalTrials.gov

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