Partial EpilepsiesPhase 3NCT00655551
Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
A Phase 3 study testing lacosamide in people with Partial Epilepsies and Partial Onset Seizures, run by UCB BIOSCIENCES, Inc. at 7 sites in United States.
Trial summary
The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Partial Epilepsies, Partial Onset Seizures
- What is being tested?
- lacosamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2008to Sep 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures
- Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days prior to screening and duration of trial
- Acceptable candidate for venipuncture and intravenous (iv) infusion
- At least 1 partial seizure with motor component per 90 days
- Maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type
Who cannot join
- Previous use of lacosamide
- History of primary generalized seizures
- History of status epilepticus within last 12 months
- History of cluster seizures during 8 week period prior to screening
- Non-epileptic events, including psychogenic seizures that could be confused with seizures
- Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening
Show all 9Show fewer
- Received any rescue benzodiazepines more than once during the 28 days prior to screening
- Concomitant treatment of felbamate or previous felbamate therapy within last 6 months
- Prior or concomitant vigabatrin use
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Baltimore, Maryland
Study site
Charlottesville, Virginia
Study site
Chesterfield, Missouri
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
About this study
Official title: A Multicenter, Open-label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Lacosamide Maintenance as Adjunctive Therapy in Subjects With Partial-onset Seizures
The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.
Read the detailed description
This multicenter, open-label trial examined safety and tolerability of rapid initiation of adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance treatment in subjects 16 - 60 years of age with partial-onset seizures. Three consecutive 25-subject cohorts were given a progressively increasing dose of lacosamide (200, 300, 400 mg) administered as a single 15-minute intravenous (iv) loading dose followed by the equivalent daily dose administered orally twice daily for 6.5 days with the first oral dose 12 hours after the iv dose. A fourth cohort of 25 subjects repeated the 300 mg dose to provide safety data on a total of 50 subjects at the highest well-tolerated dose.
- Conditions
- Partial Epilepsies, Partial Onset Seizures
- Being tested
- lacosamide
- Keywords
- epilepsy, seizures, Lacosamide, Vimpat, intravenous
- Medical subject headings
- Epilepsies, Partial, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lacosamideDrug
Also called Vimpat
Single loading intravenous (iv) lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 200 mg/day (100 mg twice daily) for 6.5 days
lacosamideDrug
Also called Vimpat
Single loading intravenous (iv) lacosamide 300 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 300 mg/day (150 mg twice daily) for 6.5 days
lacosamideDrug
Also called Vimpat
Single loading intravenous (iv) lacosamide 400 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 400 mg/day (200 mg twice daily) for 6.5 days
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide 200 mg cohort | Experimental | Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily Receives: Drug: lacosamide |
| Lacosamide 300 mg combined cohorts | Experimental | Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily Receives: Drug: lacosamide |
| Lacosamide 400 mg cohort | Experimental | Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily Receives: Drug: lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Measured: Treatment period (up to 7 days)
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Measured: Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)
Secondary outcomes (1)
Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Measured: 0-4 hours post start of the infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial EpilepsiesStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655551
- Sponsor's protocol ID
- SP0925
- Other IDs
- 2014-004378-40, 2014
- Status last verified
- Jul 2017
- First submitted
- 26 Mar 2008
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Expanded access
- Available
Publications
Fountain NB, Krauss G, Isojarvi J, Dilley D, Doty P, Rudd GD. Safety and tolerability of adjunctive lacosamide intravenous loading dose in lacosamide-naive patients with partial-onset seizures. Epilepsia. 2013 Jan;54(1):58-65. doi: 10.1111/j.1528-1167.2012.03543.x. Epub 2012 Jun 18.
PubMed 22708895
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Lacosamide Maintenance as Adjunctive Therapy in Subjects With Partial-onset Seizures
- ClinicalTrials.gov ID
- NCT00655551
- Acronym / sponsor ID
- SP0925
- Conditions
- Partial Epilepsies, Partial Onset Seizures
- Keywords
- epilepsy, seizures, Lacosamide, Vimpat, intravenous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Posted 20 Oct 2010
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 the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.
Detailed description
This multicenter, open-label trial examined safety and tolerability of rapid initiation of adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance treatment in subjects 16 - 60 years of age with partial-onset seizures. Three consecutive 25-subject cohorts were given a progressively increasing dose of lacosamide (200, 300, 400 mg) administered as a single 15-minute intravenous (iv) loading dose followed by the equivalent daily dose administered orally twice daily for 6.5 days with the first oral dose 12 hours after the iv dose. A fourth cohort of 25 subjects repeated the 300 mg dose to provide safety data on a total of 50 subjects at the highest well-tolerated dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lacosamide 200 mg cohort | Experimental | Drug: lacosamideSingle loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily |
| Lacosamide 300 mg combined cohorts | Experimental | Drug: lacosamideSingle loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily |
| Lacosamide 400 mg cohort | Experimental | Drug: lacosamideSingle loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures
- Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days prior to screening and duration of trial
- Acceptable candidate for venipuncture and intravenous (iv) infusion
- At least 1 partial seizure with motor component per 90 days
- Maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type
Key exclusion criteria (9 listed)
- Previous use of lacosamide
- History of primary generalized seizures
- History of status epilepticus within last 12 months
- History of cluster seizures during 8 week period prior to screening
- Non-epileptic events, including psychogenic seizures that could be confused with seizures
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: VimpatSingle loading intravenous (iv) lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 200 mg/day (100 mg twice daily) for 6.5 days | Drug | Lacosamide 200 mg cohort |
| lacosamideAlso: VimpatSingle loading intravenous (iv) lacosamide 300 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 300 mg/day (150 mg twice daily) for 6.5 days | Drug | Lacosamide 300 mg combined cohorts |
| lacosamideAlso: VimpatSingle loading intravenous (iv) lacosamide 400 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 400 mg/day (200 mg twice daily) for 6.5 days | Drug | Lacosamide 400 mg cohort |
Primary outcome
Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)
Time frame: Treatment period (up to 7 days)
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
Time frame: Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
1 secondary outcome
Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion
Time frame: 0-4 hours post start of the infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22708895Fountain NB, Krauss G, Isojarvi J, Dilley D, Doty P, Rudd GD. Safety and tolerability of adjunctive lacosamide intravenous loading dose in lacosamide-naive patients with partial-onset seizures. Epilepsia. 2013 Jan;54(1):58-65. doi: 10.1111/j.1528-1167.2012.03543.x. Epub 2012 Jun 18.
- FDA Safety Alerts and RecallsLink 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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lacosamide in people with Partial Epilepsies and Partial Onset Seizures, run by UCB BIOSCIENCES, Inc. at 7 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 5 inclusion and 9 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
Yes. Results are posted in the registry (first posted 20 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days) (time frame: Treatment period (up to 7 days)). The study lists 2 primary outcomes in all. 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 NCT00655551, 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 17 Jul 2018.