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A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome

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ClinicalTrials.gov Identifier: NCT03299842
Recruitment Status : Enrolling by invitation
First Posted : October 3, 2017
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Zogenix, Inc. ( Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. )

Brief Summary:
This is a sub-study to ZX008-1503. Subjects will be fitted with an Embrace seizure detection watch and seizures detected by the watch will be compared to those entered into an electronic seizure diary.

Condition or disease Intervention/treatment Phase
Dravet Syndrome Drug: ZX008 (Fenfluramine Hydrochloride) Phase 3

Detailed Description:
This sub study will include up to 20 participants who meet the entry criteria for the main Study ZX008-1503 and who are willing to wear the Embrace watch and use the Embrace Alert app for 12 consecutive weeks. Those invited to participate will undergo all procedures included in the main study during their participation in this sub-study,

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: ZX008-1503 Fenfluramine, open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory, Pilot Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome: A Sub-study to the ZX008-1503 Open-Label Extension Trial
Actual Study Start Date : August 23, 2017
Actual Primary Completion Date : August 1, 2018
Estimated Study Completion Date : January 1, 2019


Arm Intervention/treatment
Experimental: ZX008
ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will be titrated to an effective dose beginning with 0.2 mg/kg/day (maximum: 30 mg/day).
Drug: ZX008 (Fenfluramine Hydrochloride)
ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will be titrated to an effective dose beginning with 0.2 mg/kg/day (maximum: 30 mg/day).




Primary Outcome Measures :
  1. Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome [ Time Frame: 12 weeks with the option to extend to 24 weeks ]
    Caregiver burden as measured by the Perceived Stress Scale Questionnaire

  2. Overall Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome [ Time Frame: 12 weeks with the option to extend to 24 weeks ]
    User experience as measured by the 5-point Likert Ease of Use Questionnaire


Secondary Outcome Measures :
  1. Compare objective convulsive seizure count, as captured by the Embrace, to convulsive seizure count captured manually in the Embrace electronic seizure diary [ Time Frame: 12 weeks with the option to extend to 24 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is willing to wear the Embrace watch on the wrist (alternatively ankle, if needed for younger children). Subjects are asked to wear the watch for as many hours of the day as possible and for the entire night, if possible, for the duration of the sub-study.
  • Subject's parent/caregiver is willing to use the Alert App.
  • Subject/subject's caregiver is willing to ensure that the Embrace watch remains within close proximity of the paired iPod Touch running the Empatica Alert app.

Exclusion Criteria:

  • Subject has a known hypersensitivity to any of the Embrace device materials.
  • Subject has a clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to Visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.

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): NCT03299842


Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

Responsible Party: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT03299842     History of Changes
Other Study ID Numbers: ZX008-1503-SS01
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zogenix, Inc. ( Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. ):
seizure
tonic clonic
epilepsy
myoclonic
encephalopathy

Additional relevant MeSH terms:
Syndrome
Seizures
Epilepsies, Myoclonic
Disease
Pathologic Processes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Fenfluramine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs