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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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6 November 2023 |
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Main ID: |
NCT03780127 |
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Date of registration:
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14/12/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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ZX008 Expanded Access Protocol
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Scientific title:
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ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan |
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Date of first enrolment:
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August 7, 2019 |
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Target sample size:
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Recruitment status: |
Approved for marketing |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03780127 |
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Study type:
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Expanded Access |
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Study design:
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Phase:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient is male or female, age 2 years and older, inclusive as of Study Day 1.
- Patient is diagnosed with Dravet syndrome.
- Patient is experiencing convulsive seizures which are not controlled by current AEDs.
- Patient is receiving at least one AED and will remain on at least one AED for the
duration of treatment.
- Patient has been approved for inclusion by Zogenix.
Exclusion Criteria:
- Patient requires or starts using an unacceptable or contraindicated concomitant
medication.
- Patient has valvulopathy.
- Patient is at risk for pulmonary hypertension.
- Patient exclusion will be at the sole discretion of the Sponsor.
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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Dravet Syndrome
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Intervention(s)
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Drug: Fenfluramine Hydrochloride
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Secondary ID(s)
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ZX008-1800
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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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