NCT01530386

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 20, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

February 7, 2012

Last Update Submit

August 16, 2012

Conditions

Healthy Subjects

Keywords

LacosamideVimpat

Outcome Measures

Primary Outcomes (1)

  • Change In Wake After Sleep Onset From Baseline To The End Of The Treatment Period

    Wake after sleep onset is defined as the total time that is scored as awake in a polysomnography occurring between sleep onset and final wake-up.

    Baseline to end of Treatment Period (approximately 22 days)

Secondary Outcomes (2)

  • Change In Sleep Efficiency From Baseline To The End Of The Treatment Period

    Baseline to end of Treatment Period (approximately 22 days)

  • Change In Total Sleep Time From Baseline To The End Of The Treatment Period

    Baseline to end of Treatment Period (approximately 22 days)

Study Arms (1)

Lacosamide

EXPERIMENTAL

300 mg/day

Drug: Lacosamide

Interventions

LacosamideDRUG

Lacosamide will be given orally in 50 mg tablets twice a day for 7 days. The dose will increase weekly by 100 mg per day to a target dose of 300 mg per day. Once the target dose of 300 mg per day has been achieved for 9 days, a 2-day tapering of Lacosamide will occur by 100 mg per day.

Lacosamide

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

005

Little Rock, Arkansas, United States

Location

003

Cleveland, Ohio, United States

Location

004

Austin, Texas, United States

Location

001

Fredericksburg, Virginia, United States

Location

Related Publications (1)

  • Hudson JD, Guptill JT, Byrnes W, Yates SL, Williams P, D'Cruz O. Assessment of the effects of lacosamide on sleep parameters in healthy subjects. Seizure. 2015 Feb;25:155-9. doi: 10.1016/j.seizure.2014.10.012. Epub 2014 Oct 25.

    PMID: 25468512DERIVED

MeSH Terms

Interventions

Lacosamide

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic Acids

Study Officials

  • UCB Clinical Trial Call Center

    877-822-9493

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 9, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 20, 2012

Record last verified: 2012-08

Locations

US(4)