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Antiepileptic

Carisbamate for Lennox Gastaut Syndrome

Phase 1
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

Study Summary

This trial is looking at whether a drug called carisbamate is safe and well tolerated in people with a condition called Lennox-Gastaut Syndrome.

Eligible Conditions
  • Lennox Gastaut Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
12-lead electrocardiograms (ECGs)
Concomitant medication
Physical examinations
+1 more
Secondary outcome measures
Safety- adverse events

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort IVExperimental Treatment1 Intervention
Subjects 2 to <6 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Group II: Cohort IIIExperimental Treatment1 Intervention
Subjects 6 to <12 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Group III: Cohort IIExperimental Treatment1 Intervention
Subjects 12 to <18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Group IV: Cohort IExperimental Treatment1 Intervention
Subjects ≥ 18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
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
8,832 Total Patients Enrolled
2 Trials studying Lennox Gastaut Syndrome
270 Patients Enrolled for Lennox Gastaut Syndrome
Ry R Forseth, Ph.D.Study ChairSK Life Science, Inc.
2 Previous Clinical Trials
51 Total Patients Enrolled
1 Trials studying Lennox Gastaut Syndrome
18 Patients Enrolled for Lennox Gastaut Syndrome
Marc Kamin, MDStudy DirectorSK Life Science, Inc.
9 Previous Clinical Trials
2,316 Total Patients Enrolled
2 Trials studying Lennox Gastaut Syndrome
270 Patients Enrolled for Lennox Gastaut Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still being admitted to this experiment?

"Unfortunately, this clinical trial is no longer accepting participants. It was posted on May 3rd 2019 and last edited on the 12th of May 2022. If seeking other trials, there are currently 1386 recruiting patients with Lennox-Gastaut Syndrome and 1 study for Carisbamate searching for volunteers."

Answered by AI

How many participants are being monitored as part of this research endeavor?

"As of May 12th 2022, there are no longer any openings in this clinical trial. It was first posted on the 3rd of March 2019 and has since been filled. For those seeking other trials involving Lennox Gastaut Syndrome, 1386 studies are actively recruiting participants; for Carisbamate, one study is open to new patients."

Answered by AI

Has the Food and Drug Administration granted authorization to Carisbamate?

"Carisbamate's safety is rated a 1, as this trial belongs to Phase 1. This suggests that there is insufficient data regarding both its efficacy and security."

Answered by AI

What other research projects have taken place involving Carisbamate?

"At present, research into the effects of Carisbamate is ongoing in 1 trial. None are currently at Phase 3 development, and there are 5 medical centres running studies on this treatment across Lebanon, New hampshire."

Answered by AI

Is this research a pioneering effort in its field?

"Since 2019, Carisbamate has been under investigation with the first trial sponsored by SK Life Science, Inc.. After 15 participants in Phase 1 of the study were evaluated, Carisbamate received drug approval. Currently, one active clinical trial is being hosted and funded by SK Life Science, Inc.."

Answered by AI

How many sites are hosting this clinical trial?

"Patients can find participation opportunities in this study at Oregon Health and Science University, The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center), UW Valley Medical Centre, as well as five other clinical sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
2019. "Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04062981.
~3 spots leftby Apr 2025
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