Lennox Gastaut SyndromePhase 1NCT04062981
Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
A Phase 1 study testing Carisbamate in people with Lennox Gastaut Syndrome, run by SK Life Science, Inc. at 5 sites in United States.
Trial summary
Open-label extension study from YKP509C001 to evaluate the safety and tolerability of carisbamate in subjects with Lennox-Gastaut Syndrome (LGS). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Lennox Gastaut Syndrome
- What is being tested?
- Carisbamate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 May 2019to 14 Dec 2022
- Phase
- Phase 1
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who completed the YKP509C001 study
- Investigator believes subject could benefit from continued exposure to study drug
- Subjects must continue to meet all of the inclusion criteria from the YKP509C001 study
Who cannot join
- Subjects must continue to not meet any of the exclusion criteria from the YKP509C001 study
- There are no additional exclusion criteria in this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21210
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Oregon Health and Science University
Portland, Oregon, 97239
UW Valley Medical Center
Renton, Washington, 98055
The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center)
Salt Lake City, Utah, 84113
About this study
Official title: Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
Open-label extension study from YKP509C001 to evaluate the safety and tolerability of carisbamate in subjects with Lennox-Gastaut Syndrome (LGS).
Read the detailed description
Subjects who successfully completed the YKP509C001 study and could benefit from continued exposure to carisbamate.
This is an open-label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through the early termination (ET)/end of study (EOS) visit.
- Conditions
- Lennox Gastaut Syndrome
- Being tested
- Carisbamate
- Medical subject headings
- Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarisbamateDrug
Also called YKP509
An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
| Study group | Role | What they receive |
|---|---|---|
| Cohort I | Experimental | Subjects ≥ 18 years of age
These subjects will reach maximum stable dose and continue onto YKP509C002. Receives: Drug: Carisbamate |
| Cohort II | Experimental | Subjects 12 to <18 years of age
These subjects will reach maximum stable dose and continue onto YKP509C002. Receives: Drug: Carisbamate |
| Cohort III | Experimental | Subjects 6 to <12 years of age
These subjects will reach maximum stable dose and continue onto YKP509C002. Receives: Drug: Carisbamate |
| Cohort IV | Experimental | Subjects 2 to <6 years of age
These subjects will reach maximum stable dose and continue onto YKP509C002. Receives: Drug: Carisbamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concomitant medication
Safety
Measured: Up to 20 months
12-lead electrocardiograms (ECGs)
Safety
Measured: Up to 20 months
Physical examinations
Safety
Measured: Up to 20 months
Seizure Frequency
An assessment of seizure frequency will be made using a subject/caregiver seizure diary with seizure type and number of daily seizures recorded since the prior visit.
Measured: Up to 20 months
Secondary outcomes (1)
Safety- adverse events
Adverse events assessment for seriousness (yes, no) severity (mild, moderate, severe), affect on carisbamate dosing (increase,reduced, interrupted, withdrawn, no change) and outcome (recovered/resolved, recovered/resolved with sequelae, recovering/resolving, not recovered/not resolved, fatal or unknown
Measured: The duration of this OL study will be until carisbamate bas been approved for treatment of LGS and is available by prescription, or development of carisbamate for LGS has stopped, whichever is first. This could occur up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start3 May 2019
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lennox Gastaut SyndromeStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-Label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through early termination (ET)/end of study (EOS) visit
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Kamin, MD, Study director, SK Life Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062981
- Sponsor's protocol ID
- YKP509C002
- Status last verified
- Apr 2024
- First submitted
- 30 May 2019
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
- ClinicalTrials.gov ID
- NCT04062981
- Acronym / sponsor ID
- YKP509C002
- Conditions
- Lennox Gastaut Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2019 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 20 Aug 2019 (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.
Open-label extension study from YKP509C001 to evaluate the safety and tolerability of carisbamate in subjects with Lennox-Gastaut Syndrome (LGS).
Detailed description
Subjects who successfully completed the YKP509C001 study and could benefit from continued exposure to carisbamate.
This is an open-label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through the early termination (ET)/end of study (EOS) visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Open-Label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through early termination (ET)/end of study (EOS) visit
| Arm | Type | Receives |
|---|---|---|
| Cohort I | Experimental | Drug: CarisbamateSubjects ≥ 18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002. |
| Cohort II | Experimental | Drug: CarisbamateSubjects 12 to <18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002. |
| Cohort III | Experimental | Drug: CarisbamateSubjects 6 to <12 years of age These subjects will reach maximum stable dose and continue onto YKP509C002. |
| Cohort IV | Experimental | Drug: CarisbamateSubjects 2 to <6 years of age These subjects will reach maximum stable dose and continue onto YKP509C002. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who completed the YKP509C001 study
- Investigator believes subject could benefit from continued exposure to study drug
- Subjects must continue to meet all of the inclusion criteria from the YKP509C001 study
Key exclusion criteria (2 listed)
- Subjects must continue to not meet any of the exclusion criteria from the YKP509C001 study
- There are no additional exclusion criteria in this study
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 |
|---|---|---|
| CarisbamateAlso: YKP509An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate) | Drug | Cohort I, Cohort II, Cohort III, Cohort IV |
Primary outcome
Concomitant medication
Time frame: Up to 20 months
Safety
12-lead electrocardiograms (ECGs)
Time frame: Up to 20 months
Safety
Physical examinations
Time frame: Up to 20 months
Safety
Seizure Frequency
Time frame: Up to 20 months
An assessment of seizure frequency will be made using a subject/caregiver seizure diary with seizure type and number of daily seizures recorded since the prior visit.
1 secondary outcome
Safety- adverse events
Time frame: The duration of this OL study will be until carisbamate bas been approved for treatment of LGS and is available by prescription, or development of carisbamate for LGS has stopped, whichever is first. This could occur up to 36 months.
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 4 Apr 2024.
Related trials for Lennox Gastaut Syndrome
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
Not yet recruitingPhase 4
A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS
Lennox-Gastaut Syndrome
Enrolling by invitationPhase 3
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)
Developmental and Epileptic Encephalopathy
RecruitingPhase 3
An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
Lennox Gastaut Syndrome
Enrolling by invitation
Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS
Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)
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.
Marc Kamin, MD study director
SK Life Science, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carisbamate in people with Lennox Gastaut Syndrome, run by SK Life Science, Inc. at 5 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 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 4 Apr 2024. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Concomitant medication (time frame: Up to 20 months). The study lists 4 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 4 Apr 2024.