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Cenobamate for Primary Generalized Epilepsy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Primary Generalized EpilepsyCenobamate - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for people with primary generalized tonic-clonic seizures. The drug is taken once a day, either in the morning or evening. The treatment period is 22 weeks, with a 3 week follow up period.

Eligible Conditions
  • Primary Generalized Epilepsy

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Empagliflozin 25 mg
1
Xcopri
1
Sequential ascending dose cohort

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 28 Days

28 Days
Seizure Diary

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Empagliflozin 25 mg
1
Xcopri
2
Sequential ascending dose cohort

Side Effects for

YKP3089
22%Dizziness
22%Somnolence
12%Nausea
12%Headache
11%Fatigue
10%Nystagmus
8%Urinary tract infection
8%Balance disorder
7%Upper respiratory tract infection
6%Tremor
6%Nasopharyngitis
5%Vomiting
5%Diarrhea
5%Constipation
1%Anxiety
1%Drug hypersensitivity reaction
1%Status epilepticus
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT01397968) in the YKP3089 ARM group. Side effects include: Dizziness with 22%, Somnolence with 22%, Nausea with 12%, Headache with 12%, Fatigue with 11%.

Trial Design

2 Treatment Groups

Cenobamate
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

170 Total Participants · 2 Treatment Groups

Primary Treatment: Cenobamate · Has Placebo Group · Phase 3

Cenobamate
Drug
Experimental Group · 1 Intervention: Cenobamate · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cenobamate
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days

Who is running the clinical trial?

SK Life Science, Inc.Lead Sponsor
40 Previous Clinical Trials
8,742 Total Patients Enrolled
Marc Kamin, MDStudy DirectorSK Life Science, Inc.
6 Previous Clinical Trials
1,861 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female and at least 12 years old.
Written, informed consent must be obtained from the subject or their legal guardian before entering the study, in accordance with ICH GCP guidelines
Women of reproductive age are expected to use an approved method of contraception.
You have been diagnosed with PGTC seizures, either alone or in combination with other types of generalized epilepsy, without an identified cause.
You experience 5 or more PGTC seizures within a 12-week period prior to randomization.
You have undergone a routine EEG within the last 5 years before Screening/Baseline or during Pre-Randomization Period, displaying electroencephalographic abnormalities consistent with idiopathic generalized epilepsy; other coexisting conditions must be accounted for in your medical history.
You have had a CT or MRI within 10 years that excluded an advancing cause of epilepsy.
The subject has been taking 1 to 3 antiepileptic medications for at least 30 days before the initial visit.
You have been taking benzodiazepines (other than diazepam) at least once a week in the preceding 30 days to treat epilepsy, anxiety, or sleep disorder; and you will continue on this dosage unchanged throughout the study
Subjects must have been on a consistent dose of felbamate for at least 2 years and not experienced hepatotoxicity or hematologic disorders during that time.
References

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