What Is Carisbamate?
Carisbamate is an investigational drug being studied for its potential as an antiepileptic therapy. It is currently under investigation as an adjuvant therapy, meaning it would be used in combination with other treatments, for patients with Lennox-Gastaut syndrome. Carisbamate has been studied in a total of 13 trials involving 3,030 participants. The first trial began in 2007, with the latest starting in 2022. The drug is being developed primarily by SK Life Science, Inc.
While the specific mechanism of action is not detailed in the provided trial descriptions, Carisbamate is being explored for its effects in various seizure disorders. Epilepsy affects more than 50 million people worldwide. Although older antiepileptic drugs are commonly used, they often have a diverse range of side effects. New antiepileptic drugs approved since the early 1990s have shown improved tolerability profiles. Carisbamate aims to contribute to these improved treatment options.
It is being investigated for its use in conditions such as Lennox-Gastaut syndrome, complex partial epilepsy, focal motor epilepsy, and simple partial epilepsy. Additionally, studies are exploring its potential in diabetic polyneuropathy and essential tremor.
Uses and Conditions Under Study
Carisbamate is primarily under investigation for its potential to treat various forms of epilepsy and seizures. Epilepsy is a neurological disorder characterized by recurrent, unprovoked seizures, which are sudden, uncontrolled disturbances in the brain. Carisbamate is being studied as an adjuvant therapy to help manage these seizures. Conditions within this group include:
- Lennox-Gastaut Syndrome (LGS): This is a rare and severe form of childhood epilepsy, typically diagnosed between 2 and 8 years of age, often persisting into adulthood. Treatment options are limited for LGS, which is why Carisbamate is being investigated as an adjuvant antiepileptic therapy. It has been studied in 3 trials for this specific condition.
- Complex Partial Epilepsy, Focal Motor Epilepsy, Simple Partial Epilepsy, Partial Motor Epilepsy, and Epilepsies, Partial: These are types of partial seizures, meaning they originate in one part of the brain. Carisbamate is being explored for its ability to help control these localized seizure activities. These partial epilepsy conditions are collectively being studied in 10 trials.
- General Epilepsy and Seizures: Beyond specific types, Carisbamate is also being investigated for its broader efficacy in epilepsy and general seizure management, with 4 trials focusing on these broader categories.
Beyond epilepsy, Carisbamate is also being explored for other neurological conditions:
- Diabetic Polyneuropathy: This condition involves nerve damage caused by diabetes, leading to pain, numbness, and weakness. One trial is investigating Carisbamate's potential to alleviate symptoms associated with diabetic polyneuropathy.
- Essential Tremor and Movement Disorders: Essential tremor is a neurological disorder causing involuntary rhythmic shaking, often in the hands. One trial is studying Carisbamate's role in managing essential tremor and other movement disorders.
Dosing
Carisbamate has been studied in various dosage forms and strengths during its clinical trials. An oral liquid formulation of Carisbamate (S-carisbamate) at 20 mg/mL has been developed and investigated. Other studies have explored fixed oral doses.
Dosing regimens have varied depending on the study and age group:
- Adults and Adolescents (12 to 18 years old): Specific adult doses mentioned include 600 mg orally on days 2-4 in one study. Another regimen involved 75 mg twice daily for Week 1, followed by 150 mg twice daily for the remainder of the study.
- Children (4 to less than 12 years old): Dosing for younger children is weight-based, but with maximum daily limits.
- In the 200 mg BID arm, children received 4 mg/kg twice daily, not to exceed 200 mg twice daily (or a total of 400 mg per day).
- In the 300 mg BID arm, children received 5.5 mg/kg twice daily, not to exceed 300 mg twice daily (or a total of 600 mg per day).
These doses reflect investigational regimens used in clinical trials to evaluate the safety and efficacy of Carisbamate for different conditions.
Side Effects
No side effect data for Carisbamate was provided in the available clinical trial information.
Clinical Trial Results
Carisbamate for Alcohol Dependence
A study (NCT02435381) investigated Carisbamate as a potential treatment for alcohol dependence, examining its effects on alcohol urge, subjective alcohol effects, and physiological responses when combined with alcohol or placebo beverages.
- Alcohol Urge Questionnaire (AUQ) Scores: Patients receiving Carisbamate with an alcohol beverage had an average AUQ score of 3.6. Patients receiving a placebo with an alcohol beverage had an average AUQ score of 3.3. Lower scores on this scale indicate a reduced urge for alcohol.
- Biphasic Alcohol Effects Scale (BAES) Scores: Patients receiving Carisbamate with an alcohol beverage had an average BAES score of 25.2. Patients receiving a placebo with an alcohol beverage had an average BAES score of 23.4. Higher scores on this scale suggest stronger subjective effects of alcohol.
- Drug Effects Questionnaire (DEQ) Scores: Patients receiving Carisbamate with an alcohol beverage had an average DEQ score of 42.5. Patients receiving a placebo with an alcohol beverage had an average DEQ score of 36.0. Higher scores on this scale indicate stronger perceived drug effects.
- Positive and Negative Affect Schedule (PANAS) Scores: The average PANAS scores were similar across all groups, ranging from 20.4 to 21.0, suggesting no significant impact on mood.
The study also measured physiological effects:
- Heart Rate: Patients receiving Carisbamate had an average heart rate of 89.2 beats per minute, compared to 82.3 beats per minute for those receiving placebo.
- Blood Pressure: Patients receiving Carisbamate had an average systolic blood pressure of 137.1 mm Hg and an average diastolic blood pressure of 83.8 mm Hg. For comparison, patients receiving placebo had an average systolic blood pressure of 145.1 mm Hg and an average diastolic blood pressure of 85.2 mm Hg.
Currently Recruiting Trials
For individuals interested in contributing to medical research, Carisbamate is currently being investigated in a clinical trial. This study aims to gather more information about its potential benefits and safety profile for specific conditions.
One significant study, sponsored by SK Life Science, Inc., is a NCT05219617 Phase 3 trial. This trial is designed to investigate the efficacy and safety of Carisbamate as an add-on treatment for seizures associated with Lennox-Gastaut Syndrome (LGS) in both children and adults. The primary goal is to evaluate how well Carisbamate (also known as YKP509) can reduce the number of drop seizures, which include tonic, atonic, and tonic-clonic seizures, when compared to a placebo. Participants in this study will be assigned to receive either Carisbamate at a dosage of 200 mg BID or 300 mg BID, or a placebo. The study is targeting an enrollment of 252 participants to ensure robust data collection.
Where to Participate
The ongoing Phase 3 study for Carisbamate is actively recruiting participants across various locations in the United States. There are 22 sites located in 21 cities across 14 states, making it accessible to a broad range of potential volunteers.
Some of the top participating locations include:
- Tampa, Florida (2 sites)
- Jacksonville, Florida (1 site)
- Orlando, Florida (1 site)
- Wellington, Florida (1 site)
- Boise, Idaho (1 site)
- Lexington, Kentucky (1 site)
- New Orleans, Louisiana (1 site)
- Baltimore, Maryland (1 site)
- Bethesda, Maryland (1 site)
- Rochester, Minnesota (1 site)
To be eligible for this study, participants must be between 4 and 55 years of age. The trial is open to all genders, and it is specifically designed for individuals with Lennox-Gastaut Syndrome, meaning healthy volunteers are not being recruited for this particular study.
Development Timeline
The journey of Carisbamate in clinical development began on June 27, 2007, marking the start of its first clinical trial. Since then, a total of 13 trials have been conducted, involving over 3,030 participants. The primary driving force behind Carisbamate's development has been SK Life Science, Inc., which has sponsored 12 of these trials, with one additional trial sponsored by Baylor College of Medicine.
Initially, Carisbamate was explored for conditions such as IBS-C and hyperphosphatemia. Over time, the research pipeline significantly expanded to focus on neurological and pain-related conditions. This expansion included a strong emphasis on epilepsy, with studies investigating its potential for Epilepsy, Seizures, Focal Motor Epilepsy, Simple Partial Epilepsy, Partial Motor Epilepsy, and Complex Partial Seizures. Development also progressed through various phases, including 3 Phase 1 trials, 4 Phase 2 trials, and 5 Phase 3 trials, alongside one Phase 1/Phase 2 study.
The drug's potential was also explored for other conditions such as Essential Tremor, Movement Disorders, Diabetic Polyneuropathy, Painful Diabetic Neuropathy, Herpes Zoster, Neuralgia, Postherpetic Neuralgia, Alcohol Abuse, Substance Abuse, and Alcohol Dependence. The latest trial for Carisbamate commenced on February 2, 2022, underscoring the ongoing commitment to understanding its full therapeutic potential.