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ZX008 Expanded Access Protocol

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ClinicalTrials.gov Identifier: NCT03780127
Expanded Access Status : Available
First Posted : December 19, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Zogenix, Inc.

Brief Summary:
The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who do not qualify for participation in one of the ongoing ZX008 clinical trials.

Condition or disease Intervention/treatment
Dravet Syndrome Drug: Fenfluramine Hydrochloride

Detailed Description:
The treatment plan consists of an up to 12-month Treatment Period. Access is via application by your health care provider and available at one of the Expanded Access treatment centers. The dose of ZX008 for the duration of the Treatment Period will range from 0.2 mg/kg/day to a maximum of 0.8 mg/kg/day, not to exceed a total daily dose of 30 mg/day; for patients concurrently being prescribed stiripentol, the maximum will be 0.5mg/kg/day, not to exceed a total daily dose of 20 mg/day.

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan



Intervention Details:
  • Drug: Fenfluramine Hydrochloride
    ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with KD.
    Other Name: ZX008

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Ages Eligible for Study:   2 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patient is male or female, age 2 to 35 years, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780127


Contacts
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Contact: Peter St. Wecker, Ph.D. 510-338-9968 pStWecker@zogenix.com
Contact: Joseph Hogan, B.S, M.S. 510-788-8725 jhogan@zogenix.com

Sponsors and Collaborators
Zogenix, Inc.

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Responsible Party: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT03780127     History of Changes
Other Study ID Numbers: ZX008-1800
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

Additional relevant MeSH terms:
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Syndrome
Epilepsies, Myoclonic
Spasms, Infantile
Rett Syndrome
Disease
Pathologic Processes
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epileptic Syndromes
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Fenfluramine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs