EpilepsyPhase 4NCT00832884
The Safety of Intravenous Lacosamide
A Phase 4 study testing Lacosamide in people with Epilepsy, run by Le Bonheur Children's Hospital at 1 site in United States.
Trial summary
To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35 years old, inclusive, who are either unable to take oral medication or require intravenous administration of IV Lacosamide. Read more about this study
- Who is it for?
- Ages 4 to 35 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- 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
- Mar 2010to Nov 2012
- Phase
- Phase 4
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must have a diagnosis of epilepsy and have received anti-epileptic drug therapy prior to initiation of IV Lacosamide
- Patients must have a medical condition in which the parenteral administration of Lacosamide is desirable.
- Patients may be male or female.
- Patients must be 4 years of age or older, and less than age 35 years.
- Patient or his / her legally authorized representative must sign an informed consent form prior to any study specific procedures.
Who cannot join
- Patients will be excluded from entry into the study if any of the following are true:
- Patient has previously participated in any other intravenous Lacosamide study.
- Patient has status epilepticus within the last 3 months.
- Patient has a history of drug allergy to Lacosamide.
- Patient is pregnant.
- Patient has taken experimental drug within last 30 days.
- Patient with significant hepatic or renal disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
LeBonheur Children's Medical Center
Memphis, Tennessee, 38103
About this study
Official title: IV Lacosamide: The Safety of Intravenous Lacosamide
To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35 years old, inclusive, who are either unable to take oral medication or require intravenous administration of IV Lacosamide.
Read the detailed description
Lacosamide tablets and intravenous formulations were both approved in the United States in the fall of 2008. Lacosamide is indicated for use as adjunctive therapy in the treatment of partial onset seizure disorder in patients' age seventeen years and older. A parenteral dosage form of Lacosamide is desirable for patients who are temporarily unable to take medication orally. The objective of this study is to evaluate the safety of IV Lacosamide in children with epilepsy, ages 4 to 35 years, who are either unable to take oral medication, or whom parenteral administration of IV Lacosamide is desirable.
- Conditions
- Epilepsy
- Being tested
- Lacosamide
- Keywords
- partial, onset, epilepsy, pediatric, lacosamide, partial onset epilepsy, vimpat
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
Also called Vimpat
0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes.
0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group 1A | Active comparator | Lacosamide, IV, 50 mg, once, 30 minutes Receives: Drug: Lacosamide |
| Group 2A | Active comparator | Lacosamide, IV, 100 mg, once, 30 min Receives: Drug: Lacosamide |
| Group 3A | Active comparator | Lacosamide, IV, 150 mg, once, 30 min Receives: Drug: Lacosamide |
| Group 4A | Active comparator | Lacosamide, IV, 200 mg, once, 30 min Receives: Drug: Lacosamide |
| Group 1B | Active comparator | Lacosamide, IV, 50 mg, once, 15 min Receives: Drug: Lacosamide |
| Group 2B | Active comparator | Lacosamide, IV, 100 mg, once, 15 min Receives: Drug: Lacosamide |
| Group 3B | Active comparator | Lacosamide, IV, 150 mg, once, 15 min Receives: Drug: Lacosamide |
| Group 4B | Active comparator | Lacosamide, IV, 200 mg, once, 15 min Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of IV Lacosamide given as a rapid infusion.
The safety of IV Lacosamide will be assessed in patients in whom parental administration of Lacosamide is warranted.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startMar 2010
- Primary completionMay 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- 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
- NCT00832884
- Sponsor's protocol ID
- 00570-FB
- Status last verified
- Sep 2020
- First submitted
- 29 Jan 2009
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Biton V, Rosenfeld WE, Whitesides J, Fountain NB, Vaiciene N, Rudd GD. Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. Epilepsia. 2008 Mar;49(3):418-24. doi: 10.1111/j.1528-1167.2007.01317.x. Epub 2007 Sep 19.
PubMed 17888078Bialer M, Johannessen SI, Kupferberg HJ, Levy RH, Loiseau P, Perucca E. Progress report on new antiepileptic drugs: a summary of the Fifth Eilat Conference (EILAT V). Epilepsy Res. 2001 Jan;43(1):11-58. doi: 10.1016/s0920-1211(00)00171-6.
PubMed 11137386
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
- NCT00832884
- Acronym / sponsor ID
- 00570-FB
- Conditions
- Epilepsy
- Keywords
- partial, onset, epilepsy, pediatric, lacosamide, partial onset epilepsy, vimpat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Le Bonheur Children's HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Jan 2009 (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.
To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35 years old, inclusive, who are either unable to take oral medication or require intravenous administration of IV Lacosamide.
Detailed description
Lacosamide tablets and intravenous formulations were both approved in the United States in the fall of 2008. Lacosamide is indicated for use as adjunctive therapy in the treatment of partial onset seizure disorder in patients' age seventeen years and older. A parenteral dosage form of Lacosamide is desirable for patients who are temporarily unable to take medication orally. The objective of this study is to evaluate the safety of IV Lacosamide in children with epilepsy, ages 4 to 35 years, who are either unable to take oral medication, or whom parenteral administration of IV Lacosamide is desirable.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1A | Active comparator | Drug: LacosamideLacosamide, IV, 50 mg, once, 30 minutes |
| Group 2A | Active comparator | Drug: LacosamideLacosamide, IV, 100 mg, once, 30 min |
| Group 3A | Active comparator | Drug: LacosamideLacosamide, IV, 150 mg, once, 30 min |
| Group 4A | Active comparator | Drug: LacosamideLacosamide, IV, 200 mg, once, 30 min |
| Group 1B | Active comparator | Drug: LacosamideLacosamide, IV, 50 mg, once, 15 min |
| Group 2B | Active comparator | Drug: LacosamideLacosamide, IV, 100 mg, once, 15 min |
| Group 3B | Active comparator | Drug: LacosamideLacosamide, IV, 150 mg, once, 15 min |
| Group 4B | Active comparator | Drug: LacosamideLacosamide, IV, 200 mg, once, 15 min |
Who may qualify
- Ages
- 4 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients must have a diagnosis of epilepsy and have received anti-epileptic drug therapy prior to initiation of IV Lacosamide
- Patients must have a medical condition in which the parenteral administration of Lacosamide is desirable.
- Patients may be male or female.
- Patients must be 4 years of age or older, and less than age 35 years.
- Patient or his / her legally authorized representative must sign an informed consent form prior to any study specific procedures.
Key exclusion criteria (7 listed)
- Patients will be excluded from entry into the study if any of the following are true:
- Patient has previously participated in any other intravenous Lacosamide study.
- Patient has status epilepticus within the last 3 months.
- Patient has a history of drug allergy to Lacosamide.
- Patient is pregnant.
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 |
|---|---|---|
| LacosamideAlso: Vimpat0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes. 0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes | Drug | Group 1A, Group 1B, Group 2A, Group 2B, Group 3A, Group 3B, Group 4A, Group 4B |
Primary outcome
To evaluate the safety of IV Lacosamide given as a rapid infusion.
Time frame: one year
The safety of IV Lacosamide will be assessed in patients in whom parental administration of Lacosamide is warranted.
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.
- Results publication: PubMed 17888078Biton V, Rosenfeld WE, Whitesides J, Fountain NB, Vaiciene N, Rudd GD. Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. Epilepsia. 2008 Mar;49(3):418-24. doi: 10.1111/j.1528-1167.2007.01317.x. Epub 2007 Sep 19.
- Results publication: PubMed 11137386Bialer M, Johannessen SI, Kupferberg HJ, Levy RH, Loiseau P, Perucca E. Progress report on new antiepileptic drugs: a summary of the Fifth Eilat Conference (EILAT V). Epilepsy Res. 2001 Jan;43(1):11-58. doi: 10.1016/s0920-1211(00)00171-6.
- Study site websiteLink provided by the sponsor.
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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 4 study testing 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 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To evaluate the safety of IV Lacosamide given as a rapid infusion. (time frame: one year). 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 NCT00832884, which also lists 2 linked publications.
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.