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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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27 February 2023 |
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Main ID: |
NCT02175173 |
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Date of registration:
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10/06/2014 |
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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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Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome
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Scientific title:
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Date of first enrolment:
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June 13, 2013 |
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Target sample size:
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707 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02175173 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Japan
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Key inclusion & exclusion criteria
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All patients with Lennox-Gastaut syndrome and administrated Inovelon
Age minimum:
N/A
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: Rufinamide
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Primary Outcome(s)
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Investigations on adverse events and adverse drug reactions
[Time Frame: Up to 2 years]
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Secondary Outcome(s)
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Overall assessments of the improvement in the seriousness of seizures
[Time Frame: 12 weeks and every 6 months up to 2years]
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Frequency of attacks
[Time Frame: 12 weeks and every 6 months up to 2years]
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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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