EpilepsyPhase 3NCT02192814
Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures
A Phase 3 study testing Lacosamide (200 mg/20 mL) in people with Epilepsy and Partial-onset Seizures, run by UCB Japan Co. Ltd. at 5 sites in Japan.
Trial summary
EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy, Partial-onset Seizures
- What is being tested?
- Lacosamide (200 mg/20 mL)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesJapan
- Study dates
- Jun 2014to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is Japanese and enrolled in EP0009 (NCT01832038) receiving oral Lacosamide (LCM) for the treatment of partial-onset seizures and has been enrolled for at least 8 weeks
- Subject has been on a stable twice daily (bid) dosage regimen of LCM 200 mg/ day to 400 mg/ day, for the 2 weeks prior to entry into EP0024
- Subject has been receiving no more than 3 concomitant Antiepileptic Drugs (AEDs) at doses that have remained stable for the 2 weeks prior to entry into EP0024
Who cannot join
- Subject has a history of any kind of status epilepticus within 12-month period prior to study entry
- Subject has actual suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
About this study
Official title: A Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Lacosamide as Replacement for Oral Lacosamide in Japanese Adults With Partial-onset Seizures With or Without Secondary Generalization
EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures.
- Conditions
- Epilepsy, Partial-onset Seizures
- Being tested
- Lacosamide (200 mg/20 mL)
- Keywords
- Lacosamide, LCM, Epilepsy, Partial-onset seizures, iv
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacosamide (200 mg/20 mL)Drug
Also called Vimpat
Active Substance: Lacosamide
Pharmaceutical form: Solution for intravenous (iv) infusion
Concentration: adapted on concentration of oral dose in EP0009
Route of Administration: Drip infusion
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide (LCM) | Experimental | On Day - 1, LCM oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day). Receives: Drug: Lacosamide (200 mg/20 mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Total Number of Subjects Experiencing at Least One Adverse Event During the Study
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: During the study (Screening through End of Study (Day -1 through Day 6))
The Total Number of Subject Withdrawal Due to Adverse Events During the Study
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: During the study (Screening through End of Study (Day -1 through Day 6))
Secondary outcomes (6)
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1
Measured: 20 minutes prior infusion at Day 1
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2
Measured: 20 minutes prior infusion at Day 2
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5
Measured: 20 minutes prior infusion at Day 5
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1
Measured: 20 minutes prior infusion at Day 1
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2
Measured: 20 minutes prior infusion at Day 2
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5
Measured: 20 minutes prior infusion at Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionDec 2014
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Japan Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, 1-877-822-9493
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192814
- Sponsor's protocol ID
- EP0024
- Other IDs
- EP0024
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2014
- Last updated
- 25 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Lacosamide as Replacement for Oral Lacosamide in Japanese Adults With Partial-onset Seizures With or Without Secondary Generalization
- ClinicalTrials.gov ID
- NCT02192814
- Acronym / sponsor ID
- EP0024
- Conditions
- Epilepsy, Partial-onset Seizures
- Keywords
- Lacosamide, LCM, Epilepsy, Partial-onset seizures, iv
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- UCB Japan Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Posted 4 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacosamide (LCM) | Experimental | Drug: Lacosamide (200 mg/20 mL)On Day - 1, LCM oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply. During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days. The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is Japanese and enrolled in EP0009 (NCT01832038) receiving oral Lacosamide (LCM) for the treatment of partial-onset seizures and has been enrolled for at least 8 weeks
- Subject has been on a stable twice daily (bid) dosage regimen of LCM 200 mg/ day to 400 mg/ day, for the 2 weeks prior to entry into EP0024
- Subject has been receiving no more than 3 concomitant Antiepileptic Drugs (AEDs) at doses that have remained stable for the 2 weeks prior to entry into EP0024
Key exclusion criteria (2 listed)
- Subject has a history of any kind of status epilepticus within 12-month period prior to study entry
- Subject has actual suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
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 |
|---|---|---|
| Lacosamide (200 mg/20 mL)Also: VimpatActive Substance: Lacosamide Pharmaceutical form: Solution for intravenous (iv) infusion Concentration: adapted on concentration of oral dose in EP0009 Route of Administration: Drip infusion | Drug | Lacosamide (LCM) |
Primary outcome
The Total Number of Subjects Experiencing at Least One Adverse Event During the Study
Time frame: During the study (Screening through End of Study (Day -1 through Day 6))
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
The Total Number of Subject Withdrawal Due to Adverse Events During the Study
Time frame: During the study (Screening through End of Study (Day -1 through Day 6))
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
6 secondary outcomes
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1
Time frame: 20 minutes prior infusion at Day 1
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2
Time frame: 20 minutes prior infusion at Day 2
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5
Time frame: 20 minutes prior infusion at Day 5
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1
Time frame: 20 minutes prior infusion at Day 1
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2
Time frame: 20 minutes prior infusion at Day 2
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5
Time frame: 20 minutes prior infusion at Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
5 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 (200 mg/20 mL) in people with Epilepsy and Partial-onset Seizures, run by UCB Japan Co. Ltd. at 5 sites in Japan.
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 3 inclusion and 2 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 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. 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 4 Dec 2015). 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?
The Total Number of Subjects Experiencing at Least One Adverse Event During the Study (time frame: During the study (Screening through End of Study (Day -1 through Day 6))). 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?
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 25 Aug 2017.