Not provided
Not provided
Not provided
Not provided
Not provided
The study was stopped due to low enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an exploratory sub-study to ZX008-1503 [NCT02823145]. 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.
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,
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZX008 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZX008 (Fenfluramine Hydrochloride) | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Usability of the Empatica Embrace Seizure Detection Watch System (Embrace) in Outpatients With Dravet Syndrome | 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. | Approximately 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States | ||
| The Children's Hospital Colorado |
Not provided
This exploratory sub-study started to enroll participants in July 2017 and concluded in July 2018. Investigating a rare disease in pediatrics, this exploratory sub-study was terminated due to low enrolment. Of the 20 participants the Sponsor attempted to enroll in the study, only 5 participants enrolled and terminated early from the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ZX008 | Participants received ZX008 (fenfluramine hydrochloride) as an oral solution in a concentration of 2.5 milligrams per milliliter (mg/mL). Participants were titrated to an effective dose beginning with 0.2 milligrams per kilogram per day (mg/kg/day) to maximum dose of 30 mg/day. Study medication was administered twice a day (BID) in equally divided doses with food for 12 consecutive weeks, as per main study protocol, ZX008-1503 [NCT02823145]. For this substudy, ZX008-1503-SS01, all participants were required to wear the noninvasive Empatica Embrace watch system (EMBRACE) wrist-worn monitoring device. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2017 |
Not provided
Not provided
ZX008-1503 Fenfluramine, open-label
Not provided
Not provided
Not provided
Not provided
| Aurora |
| Colorado |
| 80045 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
No data will be reported, as the study was investigating a rare disease in pediatrics with a high risk of participant identification due to low enrolment (participant privacy/confidentiality issue).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ZX008 | Participants received ZX008 (fenfluramine hydrochloride) as an oral solution in a concentration of 2.5 milligrams per milliliter (mg/mL). Participants were titrated to an effective dose beginning with 0.2 milligrams per kilogram per day (mg/kg/day) to maximum dose of 30 mg/day. Study medication was administered twice a day (BID) in equally divided doses with food for 12 consecutive weeks, as per main study protocol, ZX008-1503 [NCT02823145]. For this substudy, ZX008-1503-SS01, all participants were required to wear the noninvasive Empatica Embrace watch system (EMBRACE) wrist-worn monitoring device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | participants |
| |||||||||||||||||||||
| Age, Continuous | years | ||||||||||||||||||||||
| Sex: Female, Male | participants |
| |||||||||||||||||||||
| Race/Ethnicity, Customized | participants | ||||||||||||||||||||||
| Race/Ethnicity, Customized | participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Usability of the Empatica Embrace Seizure Detection Watch System (Embrace) in Outpatients With Dravet Syndrome | 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. | No data will be reported, as the study was investigating a rare disease in pediatrics with a high risk of participant identification due to low enrolment (participant privacy/confidentiality issue). | Posted | Approximately 12 weeks |
|
|
Approximately 12 weeks
No data will be reported, as the study was investigating a rare disease in pediatrics with a high risk of participant identification due to low enrolment (participant privacy/confidentiality issue).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ZX008 | Participants received ZX008 (fenfluramine hydrochloride) as an oral solution in a concentration of 2.5 milligrams per milliliter (mg/mL). Participants were titrated to an effective dose beginning with 0.2 milligrams per kilogram per day (mg/kg/day) to maximum dose of 30 mg/day. Study medication was administered twice a day (BID) in equally divided doses with food for 12 consecutive weeks, as per main study protocol, ZX008-1503 [NCT02823145]. For this substudy, ZX008-1503-SS01, all participants were required to wear the noninvasive Empatica Embrace watch system (EMBRACE) wrist-worn monitoring device. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
No data will be reported, as the exploratory sub-study was investigating a rare disease in pediatrics with a high risk of participant identification due to low enrolment (participant privacy/confidentiality issue). Safety Data for eligible participants in the sub-study was collected in the main study ZX008-1503 (NCT02823145) as pre-specified in the protocol. The data will be disclosed with the main study results posting.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Nov 10, 2023 |
| Prot_SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D004831 | Epilepsies, Myoclonic |
| D012640 | Seizures |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005277 | Fenfluramine |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided