Healthy SubjectsPhase 1NCT01530386
A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects
A Phase 1 study testing Lacosamide in people with Healthy Subjects, run by UCB Pharma at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Lacosamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2012to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
004
Austin, Texas
003
Cleveland, Ohio
001
Fredericksburg, Virginia
005
Little Rock, Arkansas
About this study
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.
Read the detailed description
In some patients with Epilepsy, seizure activity is associated with specific phases of sleep/wake cycle, and sleep deprivation is known to precipitate seizure activity. Inadequate or disturbed sleep and excessive daytime drowsiness is often reported by patients with Epilepsy due to the effects of seizures as well as antiepileptic drugs. Thus, the use of healthy subjects improves the certainty that any changes in sleep are related to the study drug and not other factors.
- Conditions
- Healthy Subjects
- Being tested
- Lacosamide
- Keywords
- Lacosamide, Vimpat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Experimental | 300 mg/day Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Sleep efficiency is the percentage calculated by taking the total sleep time divided by the time in bed.
Measured: Baseline to end of Treatment Period (approximately 22 days)
Change In Total Sleep Time From Baseline To The End Of The Treatment Period
Total Sleep Time is the total of all sleep epochs within time in bed.
Measured: Baseline to end of Treatment Period (approximately 22 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, 877-822-9493
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530386
- Sponsor's protocol ID
- SP1031
- Status last verified
- Aug 2012
- First submitted
- 7 Feb 2012
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25468512
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01530386
- Acronym / sponsor ID
- SP1031
- Conditions
- Healthy Subjects
- Keywords
- Lacosamide, Vimpat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In some patients with Epilepsy, seizure activity is associated with specific phases of sleep/wake cycle, and sleep deprivation is known to precipitate seizure activity. Inadequate or disturbed sleep and excessive daytime drowsiness is often reported by patients with Epilepsy due to the effects of seizures as well as antiepileptic drugs. Thus, the use of healthy subjects improves the certainty that any changes in sleep are related to the study drug and not other factors.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacosamide | Experimental | Drug: Lacosamide300 mg/day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacosamideLacosamide 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. | Drug | Lacosamide |
Primary outcome
Change In Wake After Sleep Onset From Baseline To The End Of The Treatment Period
Time frame: Baseline to end of Treatment Period (approximately 22 days)
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.
2 secondary outcomes
Change In Sleep Efficiency From Baseline To The End Of The Treatment Period
Time frame: Baseline to end of Treatment Period (approximately 22 days)
Change In Total Sleep Time From Baseline To The End Of The Treatment Period
Time frame: Baseline to end of Treatment Period (approximately 22 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
- Derived from this study: PubMed 25468512Hudson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
877-822-9493
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lacosamide in people with Healthy Subjects, run by UCB Pharma at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change In Wake After Sleep Onset From Baseline To The End Of The Treatment Period (time frame: Baseline to end of Treatment Period (approximately 22 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01530386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2012.