Focal EpilepsyPhase 4NCT03607851
Efficacy and Safety of Rapid Titration Protocols of Lacosamide
A Phase 4 study testing Lacosamide - conventional titration, Lacosamide - rapid titration 1 and Lacosamide - rapid titration 2 in people with Focal Epilepsy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- Lacosamide - conventional titration, Lacosamide - rapid titration 1 and Lacosamide - rapid titration 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2018to 7 Jun 2019
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-85 years old
- Patients diagnosed with focal epilepsy
- Patients subjected to the addition of lacosamide to treat focal onset seizures according to physician's judgement
- Subjects provided informed consent
Who cannot join
- Subjects who changed other antiepileptic drugs at the beginning of lacosamide treatment
- Subjects with unstable physical, mental or other disease condition that can impede with accurate evaluation or treatment
- Subjects with terminal illness or general medical condition that can impede with the participation of the clinical trial
- Subjects who do not agree with prior consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Rapid Titration Protocols of Lacosamide: An Exploratory Study
Three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide
Read the detailed description
The investigators intend to find a way to reduce the titration period of lacosamide. Dosage of lacosamide is increased from 100-200 mg/d to 400 mg/d by three different titration schedule. Safety of lacosamide administration is primary endpoint. 50% responder rate (seizure reduction) and blood level of lacosamide are investigated for secondary endpoints.
- Conditions
- Focal Epilepsy
- Being tested
- Lacosamide - conventional titration, Lacosamide - rapid titration 1, Lacosamide - rapid titration 2
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacosamide - conventional titrationDrug
Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose at weekly intervals by 50 mg PO BID; up to 200 mg BID
Lacosamide - rapid titration 1Drug
Administration of lacosamide by the following schedule, Initial: 100 mg PO BID Increase dose to 200 mg BID after one week
Lacosamide - rapid titration 2Drug
Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose every two days by 50 mg PO BID; up to 200 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Conventional titration group | Active comparator | Not described Receives: Drug: Lacosamide - conventional titration |
| Rapid titration group 1 | Experimental | Not described Receives: Drug: Lacosamide - rapid titration 1 |
| Rapid titration group 2 | Experimental | Not described Receives: Drug: Lacosamide - rapid titration 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.
Measured: 6 (rapid titration group) or 8 weeks (conventional titration group)
Secondary outcomes (2)
Reduction of seizure frequency
50% responder rate (percentage of patients achieving a 50% or greater reduction in seizure frequency)
Measured: Baseline, 6 weeks (rapid titration group) or 8 weeks (conventional titration group)
lacosamide drug level in the blood
lacosamide drug level 1 week after the day of the daily dose of lacosamide reaches 400 mg/day
Measured: 2 weeks (rapid titration group) or 4 weeks (conventional titration group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start3 Aug 2018
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dongsan Medical Center, Konkuk University
- Responsible party
- Principal investigator, Sang Kun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607851
- Sponsor's protocol ID
- 0620181410
- Status last verified
- Feb 2020
- First submitted
- 24 Jul 2018
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291(1):56-68. doi: 10.1111/nyas.12213.
PubMed 23859801Ben-Menachem E, Biton V, Jatuzis D, Abou-Khalil B, Doty P, Rudd GD. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007 Jul;48(7):1308-17. doi: 10.1111/j.1528-1167.2007.01188.x.
PubMed 17635557Halasz P, Kalviainen R, Mazurkiewicz-Beldzinska M, Rosenow F, Doty P, Hebert D, Sullivan T; SP755 Study Group. Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial. Epilepsia. 2009 Mar;50(3):443-53. doi: 10.1111/j.1528-1167.2008.01951.x. Epub 2009 Jan 17.
PubMed 19183227Chung S, Sperling MR, Biton V, Krauss G, Hebert D, Rudd GD, Doty P; SP754 Study Group. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia. 2010 Jun;51(6):958-67. doi: 10.1111/j.1528-1167.2009.02496.x. Epub 2010 Jan 27.
PubMed 20132285
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rapid Titration Protocols of Lacosamide: An Exploratory Study
- ClinicalTrials.gov ID
- NCT03607851
- Acronym / sponsor ID
- 0620181410
- Conditions
- Focal Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dongsan Medical Center, Konkuk University
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 31 Jul 2018 (actual)
- 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.
Three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide
Detailed description
The investigators intend to find a way to reduce the titration period of lacosamide. Dosage of lacosamide is increased from 100-200 mg/d to 400 mg/d by three different titration schedule. Safety of lacosamide administration is primary endpoint. 50% responder rate (seizure reduction) and blood level of lacosamide are investigated for secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional titration group | Active comparator | Drug: Lacosamide - conventional titration |
| Rapid titration group 1 | Experimental | Drug: Lacosamide - rapid titration 1 |
| Rapid titration group 2 | Experimental | Drug: Lacosamide - rapid titration 2 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-85 years old
- Patients diagnosed with focal epilepsy
- Patients subjected to the addition of lacosamide to treat focal onset seizures according to physician's judgement
- Subjects provided informed consent
Key exclusion criteria (4 listed)
- Subjects who changed other antiepileptic drugs at the beginning of lacosamide treatment
- Subjects with unstable physical, mental or other disease condition that can impede with accurate evaluation or treatment
- Subjects with terminal illness or general medical condition that can impede with the participation of the clinical trial
- Subjects who do not agree with prior consent
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 - conventional titrationAdministration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose at weekly intervals by 50 mg PO BID; up to 200 mg BID | Drug | Conventional titration group |
| Lacosamide - rapid titration 1Administration of lacosamide by the following schedule, Initial: 100 mg PO BID Increase dose to 200 mg BID after one week | Drug | Rapid titration group 1 |
| Lacosamide - rapid titration 2Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose every two days by 50 mg PO BID; up to 200 mg BID | Drug | Rapid titration group 2 |
Primary outcome
Incidence of adverse events
Time frame: 6 (rapid titration group) or 8 weeks (conventional titration group)
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.
2 secondary outcomes
Reduction of seizure frequency
Time frame: Baseline, 6 weeks (rapid titration group) or 8 weeks (conventional titration group)
lacosamide drug level in the blood
Time frame: 2 weeks (rapid titration group) or 4 weeks (conventional titration group)
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 18 Feb 2020.
- Background: PubMed 23859801Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291(1):56-68. doi: 10.1111/nyas.12213.
- Background: PubMed 17635557Ben-Menachem E, Biton V, Jatuzis D, Abou-Khalil B, Doty P, Rudd GD. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007 Jul;48(7):1308-17. doi: 10.1111/j.1528-1167.2007.01188.x.
- Background: PubMed 19183227Halasz P, Kalviainen R, Mazurkiewicz-Beldzinska M, Rosenow F, Doty P, Hebert D, Sullivan T; SP755 Study Group. Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial. Epilepsia. 2009 Mar;50(3):443-53. doi: 10.1111/j.1528-1167.2008.01951.x. Epub 2009 Jan 17.
- Background: PubMed 20132285Chung S, Sperling MR, Biton V, Krauss G, Hebert D, Rudd GD, Doty P; SP754 Study Group. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia. 2010 Jun;51(6):958-67. doi: 10.1111/j.1528-1167.2009.02496.x. Epub 2010 Jan 27.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 - conventional titration, Lacosamide - rapid titration 1 and Lacosamide - rapid titration 2 in people with Focal Epilepsy, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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 18 Feb 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 South Korea. 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?
Incidence of adverse events (time frame: 6 (rapid titration group) or 8 weeks (conventional titration group)). 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 NCT03607851, which also lists 4 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 18 Feb 2020.