A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03299842 |
Recruitment Status :
Terminated
(The study was stopped due to low enrollment.)
First Posted : October 3, 2017
Results First Posted : November 13, 2023
Last Update Posted : November 13, 2023
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dravet Syndrome | Drug: ZX008 (Fenfluramine Hydrochloride) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | N/A |
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 : | July 12, 2017 |
Actual Primary Completion Date : | July 5, 2018 |
Actual Study Completion Date : | July 5, 2018 |
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). |
- Overall Usability of the Empatica Embrace Seizure Detection Watch System (Embrace) in Outpatients With Dravet Syndrome [ Time Frame: Approximately 12 weeks ]The assessment of user experience with Embrace watch system included Likert Ease of Use Questionnaire. The questionnaire had 3 items related to use of the Embrace watch, Mate App and Alert App. All the questions were responded on 5-point Likert scale (1-Very difficult, 2-difficult, 3-Neutral, 4-Easy and 5-Very easy). Response to each item on the questionnaire was reported. Responses across all items on the questionnaire were summed to create an overall index with total score of 0 to 15, where higher scores represents the better usability of the device.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meeting all of the main study ZX008-1503 [NCT02823145] 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.
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
United States, California | |
University of California San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Colorado | |
The Children's Hospital Colorado | |
Aurora, Colorado, United States, 80045 |
Study Director: | UCB Cares | 001 844 599 2273 |
Documents provided by UCB Pharma ( Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. ):
Responsible Party: | Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. |
ClinicalTrials.gov Identifier: | NCT03299842 |
Other Study ID Numbers: |
ZX008-1503-SS01 |
First Posted: | October 3, 2017 Key Record Dates |
Results First Posted: | November 13, 2023 |
Last Update Posted: | November 13, 2023 |
Last Verified: | November 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
seizure tonic clonic epilepsy myoclonic encephalopathy |
Seizures Epilepsies, Myoclonic Syndrome Disease Pathologic Processes Neurologic Manifestations Nervous System Diseases Epilepsy, Generalized Epilepsy Brain Diseases |
Central Nervous System Diseases Epileptic Syndromes Fenfluramine Selective Serotonin Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs |