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Carisbamate for Lennox-Gastaut Syndrome
Phase 3
Recruiting
Research Sponsored by SK Life Science, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be age 4-55 years at the time of consent/assent
Must have been <11 years old at the onset of LGS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing whether or not carisbamate can help reduce seizure frequency in people with Lennox-Gastaut Syndrome.
Who is the study for?
This trial is for children and adults aged 4-55 with Lennox Gastaut Syndrome (LGS), experiencing multiple seizure types including drop seizures. Participants must have a history of LGS onset before age 11, be on stable anti-seizure medications, and not have progressive neurological diseases or significant other health issues. Women of childbearing potential must use birth control.Check my eligibility
What is being tested?
The study tests the effectiveness of Carisbamate as an additional treatment to reduce drop seizures in those with LGS compared to a placebo. It aims to see if adding Carisbamate helps decrease the frequency of these seizures when taken alongside standard seizure medications.See study design
What are the potential side effects?
While specific side effects for Carisbamate are not listed here, common side effects for seizure medication can include dizziness, fatigue, coordination problems, changes in mood or behavior, skin rashes, and possible interaction with other drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 4 and 55 years old.
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My LGS started before I was 11 years old.
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I have Lennox-Gastaut syndrome with more than one type of seizure, including atonic or tonic seizures.
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I have had at least 2 seizures a week that could make me fall in the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
will be the percentage change from baseline in the total frequency (average per 28 days) of drop seizures with potential to fall (tonic, atonic, tonic-clonic) seizures during the double-blind treatment period.
Secondary outcome measures
Percentage change from baseline in the frequency of all types of seizures (total seizures) during the double-blind treatment period.
Subject/Caregiver Global Impression of Change (S/CGIC) in overall condition score at the last visit.
The percentage of subjects with at least a 50% reduction from baseline in the total frequency of drop seizures (tonic, atonic, tonic-clonic) during the double-blind treatment period.
Other outcome measures
5. Proportion of subjects with a 75%, 90% and 100% response rate for drop seizures (tonic, atonic, tonic-clonic), non-drop seizures, and total seizures during the maintenance phase of the double-blind treatment period.
Percentage change from baseline in non-drop seizures (myoclonic seizures, atypical absence) frequency per 28 days during the during the double-blind treatment period.
Percentage change from baseline in the 28-day frequency of: drop seizures (tonic, atonic, tonic-clonic); non-drop seizures (myoclonic seizures, atypical absence); total seizures during the maintenance phase of the double-blind treatment period.
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Carisbamate 300 mg BID armExperimental Treatment1 Intervention
Age: 4 to <12y* Titration: 2.75 mg/kg BID Maintenance: 5.5 mg/kg BID
Age: ≥12 y Titration: 150 mg BID Maintenance: 300 mg BID
Group II: Carisbamate 200 mg BID armExperimental Treatment1 Intervention
Age: 4 to <12y* Titration: 2 mg/kg BID Maintenance: 4 mg/kg BID
Age: ≥12 y Titration: 100 mg BID Maintenance: 200 mg BID
Group III: Placebo matched to 200 mg BID armPlacebo Group1 Intervention
Age: 4 to <12y* Titration: Volume equivalent to 2 mg/kg BID Maintenance: Volume equivalent to 4 mg/kg BID
Age: ≥12 y Titration: Volume equivalent to 100 mg BID Maintenance: Volume equivalent to 200 mg BID
Group IV: Placebo matched to 300 mg BID armPlacebo Group1 Intervention
Age: 4 to <12y* Titration: Volume equivalent to 2.75 mg/kg BID Maintenance: Volume equivalent to 5.5 mg/kg BID
Age: ≥12 y Titration: Volume equivalent to 150 mg BID Maintenance: Volume equivalent to 300 mg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carisbamate
2013
Completed Phase 3
~690
Find a Location
Who is running the clinical trial?
SK Life Science, Inc.Lead Sponsor
40 Previous Clinical Trials
8,595 Total Patients Enrolled
16 Trials studying Seizures
6,249 Patients Enrolled for Seizures
Marc Kamin, MDStudy DirectorSK Life Science, Inc.
9 Previous Clinical Trials
2,079 Total Patients Enrolled
6 Trials studying Seizures
2,046 Patients Enrolled for Seizures
Jimmy Schiemann, MDStudy DirectorSK Life Science, Inc.
2 Previous Clinical Trials
33 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a positive test for HIV.You have had a severe allergic reaction or a serious rash from a medication in the past.I am between 4 and 55 years old.I am scheduled for epilepsy surgery or device insertion during the study.I am using cannabidiol products that are not Epidiolex.I have used benzodiazepines more than once a week in the last month.My LGS started before I was 11 years old.I have Lennox-Gastaut syndrome with more than one type of seizure, including atonic or tonic seizures.I have been on 1 to 4 seizure medications for at least 4 weeks.I have been using felbamate for less than 18 months.You have had thoughts about hurting yourself or ending your life in the past six months.I have been on ACTH therapy in the last 6 months.I started a special diet less than 4 weeks ago or often have diarrhea.My seizures are due to a worsening brain condition, but not because of a growing brain tumor.I do not have any major health issues that could affect my safety in the study.I needed emergency help for a severe lack of oxygen in the past year.You've had a device for epilepsy treatment implanted or activated less than 5 months before the trial starts, or your device's settings have not been stable for at least 4 weeks.I am allergic to or have had a reaction to carisbamate or its ingredients.I am taking Epidiolex and not using any other CBD products.I have not been sick with a significant illness, including COVID-19, in the last 4 weeks.I stopped taking vigabatrin 5 months ago and have a normal vision test result.Your total bilirubin levels are more than two times the normal upper limit, unless you have Gilbert's syndrome.I am either male or female.I am not taking any strong medication that affects liver enzymes.You have a history of an EEG showing specific abnormal brain activity related to a condition called LGS.I can maintain accurate records of seizures.You have a history of slow development.I have had at least 2 seizures a week that could make me fall in the last month.I have not had serious heart problems like a heart attack in the last 2 years.I have not had a continuous seizure within the last 12 weeks.Your heart's electrical activity is too fast or too slow, as shown by a repeated electrocardiogram (ECG).I have not engaged in any suicidal behavior in the last 2 years.My liver is generally healthy or any liver enzyme increases are stable and not severe.You have active hepatitis B or C, as shown by positive blood tests.
Research Study Groups:
This trial has the following groups:- Group 1: Carisbamate 200 mg BID arm
- Group 2: Carisbamate 300 mg BID arm
- Group 3: Placebo matched to 200 mg BID arm
- Group 4: Placebo matched to 300 mg BID arm
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Carisbamate have potentially deadly side effects?
"Carisbamate's safety is estimated to be a 3. This is because it is a Phase 3 trial, so there is additional data that supports not only its efficacy, but also its safety."
Answered by AI
If I am middle-aged, can I still participate in this research?
"Eligibility requirements for this particular clinical trial state that patients must between the ages of 4 and 55. There are 416 other medical studies available for patients that are under 18 and 1077 for those over 65."
Answered by AI
Are there any patients who can still join this trial?
"The trial is currently recruiting patients and the most recent information available was edited on August 26th, 2022. The original posting date was April 28th, 2022. The study needs 252 more patients from 1 more site."
Answered by AI
How many people fit the requirements to participate in this clinical trial?
"That is accurate. The clinicaltrials.gov website contains information revealing that this study is looking for more research participants. This trial was first posted on April 8th, 2022 and was updated most recently on August 26th, 2022. There is a need for 252 research participants at 1 locations."
Answered by AI
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