Dravet SyndromeLEONIDaSNCT05140122
LEONIDaS Caregivers Study
An observational study of Dravet Syndrome and Depression, run by University of Oxford.
Trial summary
Dravet syndrome is a rare form of severe epilepsy that begins in the first year of life and is associated with frequent and/or prolonged seizures. Individuals with Dravet Syndrome often experience a range of comorbidities, including behavioral and developmental delays, movement and balance issues, sleep difficulties… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dravet Syndrome, Depression, Anxiety
- What is being tested?
- Multiple
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2023to 26 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Caregivers of individuals with Dravet syndrome
Who may be able to join
- Willing and able to give informed consent for participation in the study
- Aged 18 years or above
- Primary caregiver of an individual with a medical history supporting a clinical diagnosis of Dravet syndrome
- Able to access the internet
Who cannot join
- Inability to provide informed written consent
- Another caregiver of the same individual with Dravet is already enrolled in the study
About this study
Official title: The LEONIDaS(Long Term Exploration of Outcomes From New Interventions in Dravet Syndrome) Caregivers Study
Dravet syndrome is a rare form of severe epilepsy that begins in the first year of life and is associated with frequent and/or prolonged seizures. Individuals with Dravet Syndrome often experience a range of comorbidities, including behavioral and developmental delays, movement and balance issues, sleep difficulties, chronic infections, and growth and nutritional issues. Patients with Dravet syndrome are at high risk of death due to SUDEP (Sudden Unexpected Death in Epilepsy), prolonged seizures, seizure-related accidents, and infections.
Due to the severity of this condition, parents of children with Dravet syndrome are typically highly involved in their child's 24-hour care and this has a considerable impact on family life. Recent studies have highlighted the profound impact that such caregiving has on physical health, mental health, social function and financial resources. In particular, caregivers report high levels of stress and anxiety, fatigue, depression and social isolation. However, there is currently a lack of effective interventions to reduce the negative impact of caregiving on caregivers.
The aim of this study is to prospectively study carers of individuals with Dravet syndrome to identify pharmacological and psychological factors that are associated with increased or decreased vulnerability to stress, depression and anxiety. Using a naturalistic, observational design the investigators will assess a cohort of Dravet Syndrome carers every six months for 3 years in order to further characterise trajectories of caregiver burden and the factors that influence this, including factors related to the person with Dravet syndrome (e.g. age, seizure frequency/severity, treatment/medications, comorbidities) and factors related to the carer and family environment (e.g. social engagement/isolation, fatigue, finances, relationships). The investigators will use both standardized questionnaires and a neurocognitive task (Facial Expression Recognition Task) to assess vulnerability to anxiety and depression. The study will be conducted online.
- Conditions
- Dravet Syndrome, Depression, Anxiety
- Being tested
- Multiple
- Medical subject headings
- Epilepsies, Myoclonic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultipleDrug
We will collect information on all medications taken by the caregiver and the person they care for.
MultipleOther
We will collect information on all forms of therapy or medical intervention taken by the caregiver and the person they care for.
| Study group | Role | What they receive |
|---|---|---|
| Primary caregivers of individuals with Dravet Syndrome | Not described Receives: Drug: Multiple; Other: Multiple |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS)
Higher scores indicate higher symptom levels (worse outcome)
Measured: Follow up at three years
Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS)
Higher scores indicate higher symptom levels (worse outcome)
Measured: Follow up at two years
Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS)
Higher scores indicate higher symptom levels (worse outcome)
Measured: Follow up at one year
Caregiver stress scores on the UW Caregiver Stress Scale
Higher scores indicate higher symptom levels (worse outcome)
Measured: Follow up at three years
Caregiver stress scores on the UW Caregiver Stress Scale
Higher scores indicate higher symptom levels (worse outcome)
Measured: Follow up at two years
Caregiver stress scores on the UW Caregiver Stress Scale
Higher scores indicate higher symptom levels (worse outcome)
Measured: Follow up at one year
Emotional processing biases on the Facial Expression Recognition Task (FERT)
Measured: Follow up at three years
Emotional processing biases on the Facial Expression Recognition Task (FERT)
Measured: Follow up at two years
Emotional processing biases on the Facial Expression Recognition Task (FERT)
Measured: Follow up at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start26 Oct 2023 (estimated)
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Why it stopped: Funder withdrew study before enrolment started..
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dravet SyndromeStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Responsible party
- Sponsor
- Investigators
- Catherine Harmer, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140122
- Sponsor's protocol ID
- R76178/RE001
- Acronym
- LEONIDaS
- Status last verified
- Dec 2023
- First submitted
- 22 Oct 2021
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LEONIDaS(Long Term Exploration of Outcomes From New Interventions in Dravet Syndrome) Caregivers Study
- ClinicalTrials.gov ID
- NCT05140122
- Acronym / sponsor ID
- LEONIDaS / R76178/RE001
- Conditions
- Dravet Syndrome, Depression, Anxiety
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funder withdrew study before enrolment started..
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Study start
- 26 Oct 2023 (estimated)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dravet syndrome is a rare form of severe epilepsy that begins in the first year of life and is associated with frequent and/or prolonged seizures. Individuals with Dravet Syndrome often experience a range of comorbidities, including behavioral and developmental delays, movement and balance issues, sleep difficulties, chronic infections, and growth and nutritional issues. Patients with Dravet syndrome are at high risk of death due to SUDEP (Sudden Unexpected Death in Epilepsy), prolonged seizures, seizure-related accidents, and infections.
Due to the severity of this condition, parents of children with Dravet syndrome are typically highly involved in their child's 24-hour care and this has a considerable impact on family life. Recent studies have highlighted the profound impact that such caregiving has on physical health, mental health, social function and financial resources. In particular, caregivers report high levels of stress and anxiety, fatigue, depression and social isolation. However, there is currently a lack of effective interventions to reduce the negative impact of caregiving on caregivers.
The aim of this study is to prospectively study carers of individuals with Dravet syndrome to identify pharmacological and psychological factors that are associated with increased or decreased vulnerability to stress, depression and anxiety. Using a naturalistic, observational design the investigators will assess a cohort of Dravet Syndrome carers every six months for 3 years in order to further characterise trajectories of caregiver burden and the factors that influence this, including factors related to the person with Dravet syndrome (e.g. age, seizure frequency/severity, treatment/medications, comorbidities) and factors related to the carer and family environment (e.g. social engagement/isolation, fatigue, finances, relationships). The investigators will use both standardized questionnaires and a neurocognitive task (Facial Expression Recognition Task) to assess vulnerability to anxiety and depression. The study will be conducted online.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary caregivers of individuals with Dravet Syndrome | – | Drug: Multiple, Other: Multiple |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Caregivers of individuals with Dravet syndrome
Key inclusion criteria (4 listed)
- Willing and able to give informed consent for participation in the study
- Aged 18 years or above
- Primary caregiver of an individual with a medical history supporting a clinical diagnosis of Dravet syndrome
- Able to access the internet
Key exclusion criteria (2 listed)
- Inability to provide informed written consent
- Another caregiver of the same individual with Dravet is already enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MultipleWe will collect information on all medications taken by the caregiver and the person they care for. | Drug | Primary caregivers of individuals with Dravet Syndrome |
| MultipleWe will collect information on all forms of therapy or medical intervention taken by the caregiver and the person they care for. | Other | Primary caregivers of individuals with Dravet Syndrome |
Primary outcome
Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS)
Time frame: Follow up at three years
Higher scores indicate higher symptom levels (worse outcome)
Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS)
Time frame: Follow up at two years
Higher scores indicate higher symptom levels (worse outcome)
Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS)
Time frame: Follow up at one year
Higher scores indicate higher symptom levels (worse outcome)
Caregiver stress scores on the UW Caregiver Stress Scale
Time frame: Follow up at three years
Higher scores indicate higher symptom levels (worse outcome)
Caregiver stress scores on the UW Caregiver Stress Scale
Time frame: Follow up at two years
Higher scores indicate higher symptom levels (worse outcome)
Caregiver stress scores on the UW Caregiver Stress Scale
Time frame: Follow up at one year
Higher scores indicate higher symptom levels (worse outcome)
Emotional processing biases on the Facial Expression Recognition Task (FERT)
Time frame: Follow up at three years
Emotional processing biases on the Facial Expression Recognition Task (FERT)
Time frame: Follow up at two years
Emotional processing biases on the Facial Expression Recognition Task (FERT)
Time frame: Follow up at one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Harmer, PhD principal investigator
University of Oxford
Questions about this trial
What is this clinical trial studying?
An observational study of Dravet Syndrome and Depression, run by University of Oxford.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS) (time frame: Follow up at three years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.