EpilepsyPhase 3NCT01981447
IV Lacosamide: The Safety of Intravenous Lacosamide
A Phase 3 study testing IV Lacosamide in people with Epilepsy, run by Le Bonheur Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35. Read more about this study
- Who is it for?
- Ages 4 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- IV Lacosamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Aug 2012
- Phase
- Phase 3
- 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 4 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient or LAR must sign informed consent
- Diagnosis of partial onset currently uncontrolled
- Patient must have received anti-epileptic drug therapy prior to initiation
- Patient must have a medical condition in which parental administration is desireable
- Male or female
- Ages 4-35
Who cannot join
- Patient has participated in a study involving IV Lacosamide
- Patient has had an episode of status epilepticus in the last 3 months
- Drug history to lacosamide pregnant or lactating
- If of child bearing age, must have pregnancy test
- Patient has participated in an experimental drug study in last 30 days
- Patients with significant active hepatic or renal disease.
- Patients with known cardiac disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lebonheur Children's Hospital
Memphis, Tennessee, 38103
About this study
The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.
Read the detailed description
The objective of this study is to evaluate the safety of IV Lacosamide in children ages 4 years to 35 years, inclusive who are unable to take oral medications or require parenteral administration of IV Lacosamide Occasionally, patients over the age of 20 are seen at LeBonheur Children's Hospital due to the complexity of their condition, or due to a long relationship with their physician. These are exceptions which are reviewed on a case by case basis and are approved by the hospital administrator for admissions and outpatient testing.
- Conditions
- Epilepsy
- Being tested
- IV Lacosamide
- Keywords
- epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV LacosamideDrug
Also called Vimpat
Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | IV Lacosamide administered (intravenously) over 30 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1 mg/ kg and 2.9 mg/kg over 30 minutes. Receives: Drug: IV Lacosamide |
| Group B | Active comparator | IV Lacosamide to be administered (intravenously) over 15 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1mg/kg, 2,4 mg/kg Receives: Drug: IV Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events (TEAEs), reported or observed.
Bradycardia, hypotension, fatigue, nausea, somnolence.
Measured: 2 years
Measure post-infusion lacosamide plasma concentrations
Serum lacosamide level drawn from the arm opposite intravenous infusion
Measured: 2 years
Measure changes in EKG, PR interval
PR interval changes measured in seconds
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startApr 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Le Bonheur Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James W. Wheless, Le Bonheur Children's Hospital
- Investigators
- James W Wheless, MD, Principal investigator, Lebonheur Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981447
- Sponsor's protocol ID
- 09-00570-FB
- Status last verified
- Sep 2020
- First submitted
- 13 May 2013
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IV Lacosamide: The Safety of Intravenous Lacosamide
- ClinicalTrials.gov ID
- NCT01981447
- Acronym / sponsor ID
- 09-00570-FB
- Conditions
- Epilepsy
- Keywords
- epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Le Bonheur Children's HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Nov 2013 (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 purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.
Detailed description
The objective of this study is to evaluate the safety of IV Lacosamide in children ages 4 years to 35 years, inclusive who are unable to take oral medications or require parenteral administration of IV Lacosamide Occasionally, patients over the age of 20 are seen at LeBonheur Children's Hospital due to the complexity of their condition, or due to a long relationship with their physician. These are exceptions which are reviewed on a case by case basis and are approved by the hospital administrator for admissions and outpatient testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: IV LacosamideIV Lacosamide administered (intravenously) over 30 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1 mg/ kg and 2.9 mg/kg over 30 minutes. |
| Group B | Active comparator | Drug: IV LacosamideIV Lacosamide to be administered (intravenously) over 15 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1mg/kg, 2,4 mg/kg |
Who may qualify
- Ages
- 4 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patient or LAR must sign informed consent
- Diagnosis of partial onset currently uncontrolled
- Patient must have received anti-epileptic drug therapy prior to initiation
- Patient must have a medical condition in which parental administration is desireable
- Male or female
Key exclusion criteria (7 listed)
- Patient has participated in a study involving IV Lacosamide
- Patient has had an episode of status epilepticus in the last 3 months
- Drug history to lacosamide pregnant or lactating
- If of child bearing age, must have pregnancy test
- Patient has participated in an experimental drug study in last 30 days
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 |
|---|---|---|
| IV LacosamideAlso: VimpatLacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy. | Drug | Group A, Group B |
Primary outcome
Number of participants with treatment-related adverse events (TEAEs), reported or observed.
Time frame: 2 years
Bradycardia, hypotension, fatigue, nausea, somnolence.
Measure post-infusion lacosamide plasma concentrations
Time frame: 2 years
Serum lacosamide level drawn from the arm opposite intravenous infusion
Measure changes in EKG, PR interval
Time frame: 2 years
PR interval changes measured in seconds
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 22 Sep 2020.
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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.
James W Wheless, MD principal investigator
Lebonheur Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IV Lacosamide in people with Epilepsy, run by Le Bonheur Children's Hospital at 1 site 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 6 inclusion and 7 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 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of participants with treatment-related adverse events (TEAEs), reported or observed. (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2020.