Rolandic EpilepsyPhase 4CASTLENCT04610879
Changing Agendas on Sleep, Treatment and Learning in Epilepsy
A Phase 4 study testing Carbamazepine, Levetiracetam and Parent based sleep (PBS) intervention in people with Rolandic Epilepsy, run by King's College London at 3 sites in United Kingdom.
Trial summary
Rolandic epilepsy (RE) is the most common type of epilepsy. Children with RE have seizures and can often find that their learning, sleep, behaviour, self-esteem and mood are affected. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Rolandic Epilepsy
- What is being tested?
- Carbamazepine, Levetiracetam and Parent based sleep (PBS) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 2 Aug 2019to 23 Sep 2020
- Phase
- Phase 4
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with RE (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-overview.html)
- EEG showing focal sharp waves with normal background (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-eeg.html)
- Aged ≥5 years and <13 years at the time of randomisation
- Currently untreated with antiepileptic drugs
- Written informed consent received from person with parental responsibility/legal representative.
- Family have an email address and regular internet access (for online sleep intervention)
- Parent and child are to have a good understanding of the English language
Who cannot join
- Known contraindication to any of the trial drugs
- Previously treated for epilepsy with antiepileptic drugs
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
King's College Hospital NHS Foundation Trust
London, SE5 8EF
Tameside Hospital
Manchester
Whiston Hospital
Whiston
About this study
Official title: Randomised Factorial Design Controlled Trial Comparing Carbamazepine, Levetiracetam or Active Monitoring Combined With or Without Sleep Behaviour Intervention in Treatment Naive Children With Rolandic Epilepsy
Rolandic epilepsy (RE) is the most common type of epilepsy. Children with RE have seizures and can often find that their learning, sleep, behaviour, self-esteem and mood are affected.
As part of standard NHS care, children diagnosed with RE may be treated with standard anti-epileptic medicines, like carbamazepine, or no medicine at all. The medicines used to treat epilepsy often slow down a child's thinking and learning. In the past, doctors believed this was an acceptable price to pay to reduce seizures. However, with RE, where the seizures usually stop in teenage years, investigators do not know if it is better to treat these children with medicines or not, especially if the medicines might have a negative effect on their learning.
Read more
A newer medicine called levetiracetam has also been found to work in children with RE and has shown less problems with thinking and learning in adults. However, it is still no known if this is also the case for children and it has not been proven which of the three options (carbamazepine, levetiracetam or no treatment) would be best for RE patients. The CASTLE study aims to find this out.
In addition, it has been found that seizures often happen when a child has had poor sleep and they often come at night or early in the morning. It has been shown that sleep can be improved through practice without the need of medicines. There are established guidelines to help toddlers go to sleep, but nothing available that helps young people with epilepsy and their parents improve their sleep quality. In the CASTLE study, a sleep training plan has been developed for children with epilepsy and the trial aims to find out whether following this sleep training plan results in less seizures than using no sleep training at all.
Read the detailed description
The trial is a phase IV randomised factorial design controlled trial comparing carbamazepine, levetiracetam or active monitoring combined with or without sleep behaviour intervention. A factorial trial design has been used as this approach enables the efficient simultaneous investigation of AED (carbamazepine; levetiracetam; no AED) and sleep behaviour intervention (vs standard care) by including all participants in both analyses. In a factorial trial it is also possible to consider both the separate effects of each intervention and the benefits of receiving both interventions together (for example levetiracetam and sleep intervention).
The CASTLE trial will take place in NHS out-patient paediatric epilepsy and general paediatric clinics in the United Kingdom (UK).
Once consent has been obtained from the appropriate adult, and assent from the child if appropriate, by the delegated member of the research team the eligibility assessments will be completed, full eligibility confirmed (confirmation must be by a medically qualified doctor) and baseline data will be collected prior to randomisation.
Randomisation will be performed via a web based tool accessed by research team at site. This system is generated centrally by the Clinical Trial Research Centre (CTRC) using a computer algorithm concealed from the investigators and research teams/trial management group. In order to balance the groups, minimisation for variables believed to influence disease outcome and end points will be built into the randomisation algorithm.
Participants will be randomised to treatment with carbamazepine, levetiracetam or active monitoring. Where randomised to drug treatment, the randomised treatment should ideally begin on the day of randomisation or within 14 days of randomisation at the latest. Randomised treatment will continue for a minimum of 12 months and a maximum of 48 months. All treatments will be procured, prescribed and issued as per routine NHS practice.
Clinical data capture will be in the form of paper copies of Case Report Forms (CRFs) that will be returned as an on-going process from each centre to the CTRC. Patient/parent reported data will be collected directly on paper at each outpatient visit with the exception of CANTAB, which will be collected on iPads at the centre.
All trial documents (except raw Hospital Episode Statistics (HES) from NHS digital that will only be retained for 1 year) will be retained for 25 years from the End of Trial. The PI at each investigational centre must make arrangements to store the essential trial documents, (as defined in Essential Documents for the Conduct of a Clinical Trial (ICH E6, Guideline for Good Clinical Practice)) including the ISF, until the CTRC informs the investigator that the documents are no longer to be retained
- Conditions
- Rolandic Epilepsy
- Being tested
- Carbamazepine, Levetiracetam, Parent based sleep (PBS) intervention
- Medical subject headings
- Epilepsy, Rolandic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbamazepineDrug
Treatment will be procured, prescribed and issued as per routine NHS practice. Generics can be prescribed.
LevetiracetamDrug
Treatment will be procured, prescribed and issued as per routine NHS practice. Generics can be prescribed.
Parent based sleep (PBS) interventionBehavioural
Also called CASTLE Online Sleep Intervention (COSI)
The PBS intervention is an e-learning package for parents/primary carers and children with epilepsy. The PBS intervention offers parents education about normal sleep, advice about sleep-promoting practices and targeted strategies parents can employ to help their children to ''learn'' an appropriate set of sleep behaviours/habits and/or to unlearn inappropriate sleep behaviours.
| Study group | Role | What they receive |
|---|---|---|
| Carbamazepine plus sleep intervention | Active comparator | Not described Receives: Drug: Carbamazepine; Behavioral: Parent based sleep (PBS) intervention |
| Carbamazepine plus standard care | Active comparator | Not described Receives: Drug: Carbamazepine |
| Levetiracetam plus sleep intervention | Active comparator | Not described Receives: Drug: Levetiracetam; Behavioral: Parent based sleep (PBS) intervention |
| Levetiracetam plus standard care | Active comparator | Not described Receives: Drug: Levetiracetam |
| No AED plus sleep intervention | Active comparator | Not described Receives: Behavioral: Parent based sleep (PBS) intervention |
| No AED plus standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 6-month seizure remission
To determine if carbamazepine or levetiracetam are superior to no anti-epileptic drugs
Measured: Up to 48 months
Change from baseline to total sleep problem score as measured by the Children's Sleep Habits Questionnaire (CSHQ)
To determine if a Parent-Based Sleep intervention is superior to standard care
Measured: At 3 months
Secondary outcomes (19)
Total costs measured in Quality-Adjusted Life Years (QALYs)
To estimate the cost-utility of carbamazepine, levetiracetam and PBS
Measured: At 0, 3, 12, 24, 36 and 48 months
Time taken from randomisation to decision by child, parent or treating physician to be withdrawn from treatment due to inadequate seizure control or unacceptable adverse reactions
To compare time to treatment failure due to inadequate seizure control or unacceptable adverse reactions
Measured: At 3, 6,12, 24, 36 and 48 months
Time taken from randomisation to decision by child, parent or treating physician to be withdrawn from treatment due to inadequate seizure control
To compare time to treatment failure due to inadequate seizure control
Measured: At 3, 6,12, 24, 36 and 48 months
Time taken from recruitment to decision by child, parent or treating physician to be withdrawn from trial due to unacceptable adverse reactions
To compare time to treatment failure due to unacceptable adverse reactions
Measured: At 3, 6,12, 24, 36 and 48 months
Time to first seizure based on seizure report
To compare time to first seizure
Measured: At 3, 6,12, 24, 36 and 48 months
Time to 12-month seizure remission based on seizure report
To compare time to 12-month remission from seizures
Measured: At 3, 6,12, 24, 36 and 48 months
Total sleep problem score as measured by the Children's Sleep Habits Questionnaire (CSHQ)
To determine if a Parent-Based Sleep intervention is superior to standard care
Measured: At 12, 24, 36 and 48 months
Total score in three chosen assessments delivered by the Cambridge Neuropsychological Test Automated Battery (CANTAB)
To compare measures of cognition across the different treatment groups
Measured: At 0, 3, 6,12, 24, 36 and 48 months
Score change in Health Related Quality of Life in Children with Epilepsy - Child self-report scale (CHEQOL)
To compare Health Related Quality of Life across the different treatment groups
Measured: At 0, 12, 24, 36 and 48 months
Total score on Strengths and Difficulties Questionnaire (SDQ)
To compare measures of children's behaviour across the different treatment groups
Measured: At 0, 12, 24, 36 and 48 months
Records of adverse reactions
To identify any adverse reactions and their rate
Measured: At 3, 6, 12, 24, 36 and 48 months
Score changes in Child Health Utility instrument (CHU9D)
To estimate child health utilities and Quality-Adjusted Life Years (QALYs) across the different treatment groups
Measured: At 0, 3, 12, 24, 36 and 48 months
Score changes in EQ-5D-Y
To estimate child health utilities and Quality-Adjusted Life Years (QALYs) across the different treatment groups
Measured: At 0, 3, 12, 24, 36 and 48 months
EQ-5D-5L score change
To estimate health utilities and Quality-Adjusted Life Years (QALYs) across parents in the different treatment groups
Measured: At 0, 3, 12, 24, 36 and 48 months
Score changes in Parental Self-Efficacy Measure (PSAM)
To compare parenting self-efficacy across the different treatment groups
Measured: At 0, 3, 12, 24, 36 and 48 months
Total sickness related school absences (days)
To compare sickness related school absences across the different treatment groups
Measured: At 0, 3, 6, 12, 24, 36 and 48 months
Resource Use Questionnaire
To determine the costs to the National Health Service (NHS)
Measured: At 3, 12, 24, 36 and 48 months
Hospital Episode Statistics (HES) Data
To determine the costs to the National Health Service (NHS)
Measured: 48 months, measured for the participant's study duration
Patient Level Information and Costing System (PLICS) Data
To determine the costs to the National Health Service (NHS)
Measured: 48 months, measured for the participant's study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start2 Aug 2019
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Why it stopped: Following the internal pilot, the study did not meet prespecified stop/go criteria for continuation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rolandic EpilepsyStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The trial is a phase IV randomised factorial design controlled trial comparing carbamazepine, levetiracetam or active monitoring combined with or without sleep behaviour intervention. We have used a factorial trial design as this approach enables the efficient simultaneous investigation of anti-epileptic drug (AED) (carbamazepine; levetiracetam; no AED) and sleep behaviour intervention (vs standard care) by including all participants in both analyses. In a factorial trial it is also possible to consider both the separate effects of each intervention and the benefits of receiving both interventions together (for example levetiracetam and sleep intervention).
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust, University of Liverpool, Bangor University, Edge Hill University, Oxford Brookes University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610879
- Sponsor's protocol ID
- CASTLE
- Other IDs
- 2018-003893-29, RP-PG-0615-20007, 2018
- Acronym
- CASTLE
- Status last verified
- Oct 2020
- First submitted
- 9 Jul 2019
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The current data sharing plans for this study are unknown and will be available at a later date
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Factorial Design Controlled Trial Comparing Carbamazepine, Levetiracetam or Active Monitoring Combined With or Without Sleep Behaviour Intervention in Treatment Naive Children With Rolandic Epilepsy
- ClinicalTrials.gov ID
- NCT04610879
- Acronym / sponsor ID
- CASTLE / CASTLE
- Conditions
- Rolandic Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following the internal pilot, the study did not meet prespecified stop/go criteria for continuation.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust, University of Liverpool, Bangor University, Edge Hill University, Oxford Brookes University
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 2 Nov 2020 (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.
Rolandic epilepsy (RE) is the most common type of epilepsy. Children with RE have seizures and can often find that their learning, sleep, behaviour, self-esteem and mood are affected.
As part of standard NHS care, children diagnosed with RE may be treated with standard anti-epileptic medicines, like carbamazepine, or no medicine at all. The medicines used to treat epilepsy often slow down a child's thinking and learning. In the past, doctors believed this was an acceptable price to pay to reduce seizures. However, with RE, where the seizures usually stop in teenage years, investigators do not know if it is better to treat these children with medicines or not, especially if the medicines might have a negative effect on their learning.
A newer medicine called levetiracetam has also been found to work in children with RE and has shown less problems with thinking and learning in adults. However, it is still no known if this is also the case for children and it has not been proven which of the three options (carbamazepine, levetiracetam or no treatment) would be best for RE patients. The CASTLE study aims to find this out.
In addition, it has been found that seizures often happen when a child has had poor sleep and they often come at night or early in the morning. It has been shown that sleep can be improved through practice without the need of medicines. There are established guidelines to help toddlers go to sleep, but nothing available that helps young people with epilepsy and their parents improve their sleep quality. In the CASTLE study, a sleep training plan has been developed for children with epilepsy and the trial aims to find out whether following this sleep training plan results in less seizures than using no sleep training at all.
Detailed description
The trial is a phase IV randomised factorial design controlled trial comparing carbamazepine, levetiracetam or active monitoring combined with or without sleep behaviour intervention. A factorial trial design has been used as this approach enables the efficient simultaneous investigation of AED (carbamazepine; levetiracetam; no AED) and sleep behaviour intervention (vs standard care) by including all participants in both analyses. In a factorial trial it is also possible to consider both the separate effects of each intervention and the benefits of receiving both interventions together (for example levetiracetam and sleep intervention).
The CASTLE trial will take place in NHS out-patient paediatric epilepsy and general paediatric clinics in the United Kingdom (UK).
Once consent has been obtained from the appropriate adult, and assent from the child if appropriate, by the delegated member of the research team the eligibility assessments will be completed, full eligibility confirmed (confirmation must be by a medically qualified doctor) and baseline data will be collected prior to randomisation.
Randomisation will be performed via a web based tool accessed by research team at site. This system is generated centrally by the Clinical Trial Research Centre (CTRC) using a computer algorithm concealed from the investigators and research teams/trial management group. In order to balance the groups, minimisation for variables believed to influence disease outcome and end points will be built into the randomisation algorithm.
Participants will be randomised to treatment with carbamazepine, levetiracetam or active monitoring. Where randomised to drug treatment, the randomised treatment should ideally begin on the day of randomisation or within 14 days of randomisation at the latest. Randomised treatment will continue for a minimum of 12 months and a maximum of 48 months. All treatments will be procured, prescribed and issued as per routine NHS practice.
Clinical data capture will be in the form of paper copies of Case Report Forms (CRFs) that will be returned as an on-going process from each centre to the CTRC. Patient/parent reported data will be collected directly on paper at each outpatient visit with the exception of CANTAB, which will be collected on iPads at the centre.
All trial documents (except raw Hospital Episode Statistics (HES) from NHS digital that will only be retained for 1 year) will be retained for 25 years from the End of Trial. The PI at each investigational centre must make arrangements to store the essential trial documents, (as defined in Essential Documents for the Conduct of a Clinical Trial (ICH E6, Guideline for Good Clinical Practice)) including the ISF, until the CTRC informs the investigator that the documents are no longer to be retained
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- The trial is a phase IV randomised factorial design controlled trial comparing carbamazepine, levetiracetam or active monitoring combined with or without sleep behaviour intervention. We have used a factorial trial design as this approach enables the efficient simultaneous investigation of anti-epileptic drug (AED) (carbamazepine; levetiracetam; no AED) and sleep behaviour intervention (vs standard care) by including all participants in both analyses. In a factorial trial it is also possible to consider both the separate effects of each intervention and the benefits of receiving both interventions together (for example levetiracetam and sleep intervention).
| Arm | Type | Receives |
|---|---|---|
| Carbamazepine plus sleep intervention | Active comparator | Drug: Carbamazepine, Behavioral: Parent based sleep (PBS) intervention |
| Carbamazepine plus standard care | Active comparator | Drug: Carbamazepine |
| Levetiracetam plus sleep intervention | Active comparator | Drug: Levetiracetam, Behavioral: Parent based sleep (PBS) intervention |
| Levetiracetam plus standard care | Active comparator | Drug: Levetiracetam |
| No AED plus sleep intervention | Active comparator | Behavioral: Parent based sleep (PBS) intervention |
| No AED plus standard care | No intervention | – |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children diagnosed with RE (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-overview.html)
- EEG showing focal sharp waves with normal background (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-eeg.html)
- Aged ≥5 years and <13 years at the time of randomisation
- Currently untreated with antiepileptic drugs
- Written informed consent received from person with parental responsibility/legal representative.
Key exclusion criteria (2 listed)
- Known contraindication to any of the trial drugs
- Previously treated for epilepsy with antiepileptic drugs
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 |
|---|---|---|
| CarbamazepineTreatment will be procured, prescribed and issued as per routine NHS practice. Generics can be prescribed. | Drug | Carbamazepine plus sleep intervention, Carbamazepine plus standard care |
| LevetiracetamTreatment will be procured, prescribed and issued as per routine NHS practice. Generics can be prescribed. | Drug | Levetiracetam plus sleep intervention, Levetiracetam plus standard care |
| Parent based sleep (PBS) interventionAlso: CASTLE Online Sleep Intervention (COSI)The PBS intervention is an e-learning package for parents/primary carers and children with epilepsy. The PBS intervention offers parents education about normal sleep, advice about sleep-promoting practices and targeted strategies parents can employ to help their children to ''learn'' an appropriate set of sleep behaviours/habits and/or to unlearn inappropriate sleep behaviours. | Behavioural | Carbamazepine plus sleep intervention, Levetiracetam plus sleep intervention, No AED plus sleep intervention |
Primary outcome
Time to 6-month seizure remission
Time frame: Up to 48 months
To determine if carbamazepine or levetiracetam are superior to no anti-epileptic drugs
Change from baseline to total sleep problem score as measured by the Children's Sleep Habits Questionnaire (CSHQ)
Time frame: At 3 months
To determine if a Parent-Based Sleep intervention is superior to standard care
19 secondary outcomes
Total costs measured in Quality-Adjusted Life Years (QALYs)
Time frame: At 0, 3, 12, 24, 36 and 48 months
Time taken from randomisation to decision by child, parent or treating physician to be withdrawn from treatment due to inadequate seizure control or unacceptable adverse reactions
Time frame: At 3, 6,12, 24, 36 and 48 months
Time taken from randomisation to decision by child, parent or treating physician to be withdrawn from treatment due to inadequate seizure control
Time frame: At 3, 6,12, 24, 36 and 48 months
Time taken from recruitment to decision by child, parent or treating physician to be withdrawn from trial due to unacceptable adverse reactions
Time frame: At 3, 6,12, 24, 36 and 48 months
Time to first seizure based on seizure report
Time frame: At 3, 6,12, 24, 36 and 48 months
Time to 12-month seizure remission based on seizure report
Time frame: At 3, 6,12, 24, 36 and 48 months
Total sleep problem score as measured by the Children's Sleep Habits Questionnaire (CSHQ)
Time frame: At 12, 24, 36 and 48 months
Total score in three chosen assessments delivered by the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: At 0, 3, 6,12, 24, 36 and 48 months
Score change in Health Related Quality of Life in Children with Epilepsy - Child self-report scale (CHEQOL)
Time frame: At 0, 12, 24, 36 and 48 months
Total score on Strengths and Difficulties Questionnaire (SDQ)
Time frame: At 0, 12, 24, 36 and 48 months
Records of adverse reactions
Time frame: At 3, 6, 12, 24, 36 and 48 months
Score changes in Child Health Utility instrument (CHU9D)
Time frame: At 0, 3, 12, 24, 36 and 48 months
Score changes in EQ-5D-Y
Time frame: At 0, 3, 12, 24, 36 and 48 months
EQ-5D-5L score change
Time frame: At 0, 3, 12, 24, 36 and 48 months
Score changes in Parental Self-Efficacy Measure (PSAM)
Time frame: At 0, 3, 12, 24, 36 and 48 months
Total sickness related school absences (days)
Time frame: At 0, 3, 6, 12, 24, 36 and 48 months
Resource Use Questionnaire
Time frame: At 3, 12, 24, 36 and 48 months
Hospital Episode Statistics (HES) Data
Time frame: 48 months, measured for the participant's study duration
Patient Level Information and Costing System (PLICS) Data
Time frame: 48 months, measured for the participant's study duration
Results and safety
The study was stopped early (reason given: Following the internal pilot, the study did not meet prespecified stop/go criteria for continuation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Individual participant dataSharing planned: Undecided. The current data sharing plans for this study are unknown and will be available at a later date
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carbamazepine, Levetiracetam and Parent based sleep (PBS) intervention in people with Rolandic Epilepsy, run by King's College London at 3 sites in United Kingdom.
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 7 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: stopped early, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Following the internal pilot, the study did not meet prespecified stop/go criteria for continuation.). Results are not available in the source record.
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?
Time to 6-month seizure remission (time frame: Up to 48 months). The study lists 2 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 2 Nov 2020.