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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 April 2024 |
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Main ID: |
NCT04062981 |
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Date of registration:
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30/05/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
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Scientific title:
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Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome |
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Date of first enrolment:
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May 3, 2019 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04062981 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Marc Kamin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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SK Life Science, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- Subjects must continue to not meet any of the exclusion criteria from the YKP509C001
study
- There are no additional exclusion criteria in this study
Age minimum:
2 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lennox Gastaut Syndrome
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Intervention(s)
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Drug: Carisbamate
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Primary Outcome(s)
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Seizure Frequency
[Time Frame: Up to 20 months]
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Concomitant medication
[Time Frame: Up to 20 months]
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12-lead electrocardiograms (ECGs)
[Time Frame: Up to 20 months]
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Physical examinations
[Time Frame: Up to 20 months]
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Secondary Outcome(s)
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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.]
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Secondary ID(s)
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YKP509C002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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