CSWSPhase 2NCT07221968
Melatonin for the Treatment of DEE-SWAS
A Phase 2 study testing Melatonin in people with CSWS and Developmental and/or Epileptic Encephalopathies, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc..
Trial summary
The goal of this study is to learn if melatonin, a naturally produced substance, can help to treat some of the symptoms of DEE-SWAS, a type of epilepsy that causes children to lose skills and development. It will look at doses of melatonin that are higher than most people use. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- CSWS, Developmental and/or Epileptic Encephalopathies, Electrical Status Epilepticus in Sleep
- What is being tested?
- Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinic Dx of DEE-SWAS
- Dx of DEE-SWAS by a board-certified pediatric neurology/epileptologist Clinical history of delayed milestones in at least 1 category, regression of milestones in at least 1 category, and/or failure to progress in milestones in at least 1 category
- Abnormal baseline neuropsychiatric testing consistent with Dx Abnormal EEG
- Epileptiform abnormalities (spike, polyspike, sharp) in at least 1 head region
- Increase by 2-fold of epileptiform abnormalities during NREM sleep as compared to wakefulness
- SWI of ≥50% in at least one head region on overnight EEG
Who cannot join
- Allergic to ingredients in study drug Melatonin
- Hypoallergenic plant fiber (cellulose)
- Active use of the medication viloxazine
- History of known cardiac rhythm abnormalities, heart failure or decreased EF <30%
- History of known pulm requiring oxygen or invasive positive pressure ventilation. Patients with non-invasive PPV (e.g. CPAP) due OSA w/o 02 requirement, rate, or DX of CSA, on stable pressure settings for >3 mnths will not be excluded.
- History of liver dysf OR AST/ALT/AlkPhos >2.5 ULN w/i year. If lab value meeting exclusion between 3-12 months, a repeat lab value < 2.5 ULN will be considered for inclusion
- Post-menarchal participants. of childbearing potential with a positive urine pregnancy test
About this study
Official title: Melatonin for the Treatment of Developmental/Epileptic Encephalopathy With Spike Wave Activation In Sleep (DEE-SWAS; Formerly ESES)
The goal of this study is to learn if melatonin, a naturally produced substance, can help to treat some of the symptoms of DEE-SWAS, a type of epilepsy that causes children to lose skills and development. It will look at doses of melatonin that are higher than most people use.
The study will look at the safety of melatonin in patients with DEE-SWAS The study will look at the ways melatonin affects abnormal brain activity on a study called an EEG.
The study will look at the ways melatonin affects normal brain activity that occurs in sleep.
- Conditions
- CSWS, Developmental and/or Epileptic Encephalopathies, Electrical Status Epilepticus in Sleep
- Being tested
- Melatonin
- Keywords
- DEE-SWAS, ESES, CSWS, epileptic encephalopathy, melatonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Melatonin will be used in single fixed dose as described
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Melatonin 0.3mg/kg (20mg max) Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
This study will evaluate for adverse events associated with single high dose melatonin administration
Measured: Within 24 hours of dose administration
Side effects
This study will evaluate for multiorgan adverse effects associated with single high dose melatonin administration based on standardized questionnaire assessment. The assessment is a multiorgan adverse event questionnaire described in Jarernsiripornkul 2001, modified to reflect single dosing rather than chronic dosing. The results of this questionanaire are descriptive.
Measured: Within 24 hours of dose administration
Secondary outcomes (3)
Spike wave index (SWI)
This study will evaluate change in epileptiform activity during NREM sleep as defined by common clinical definition of SWI - average percentage of second bins containing an epileptiform discharge during NREM sleep
Measured: Within 24 hours of dose administration
Sleep spindle
This study will evaluate change in sleep spindle activity during NREM sleep using both blinded review and validated deep learning algorithmic detection.
Measured: Within 24 hours of dose administration
Salivary melatonin pharmacokinetics
Baseline and post intervention salivary melatonin levels will be obtained at multiple time points
Measured: 24 hours prior to intervention and 24 hours following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CSWSStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single dose administration
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Carosella, Christopher, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221968
- Sponsor's protocol ID
- IRB00478764
- Status last verified
- Oct 2025
- First submitted
- 27 Oct 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin for the Treatment of Developmental/Epileptic Encephalopathy With Spike Wave Activation In Sleep (DEE-SWAS; Formerly ESES)
- ClinicalTrials.gov ID
- NCT07221968
- Acronym / sponsor ID
- IRB00478764
- Conditions
- CSWS, Developmental and/or Epileptic Encephalopathies, Electrical Status Epilepticus in Sleep
- Keywords
- DEE-SWAS, ESES, CSWS, epileptic encephalopathy, melatonin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 29 Oct 2025 (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.
The goal of this study is to learn if melatonin, a naturally produced substance, can help to treat some of the symptoms of DEE-SWAS, a type of epilepsy that causes children to lose skills and development. It will look at doses of melatonin that are higher than most people use.
The study will look at the safety of melatonin in patients with DEE-SWAS The study will look at the ways melatonin affects abnormal brain activity on a study called an EEG.
The study will look at the ways melatonin affects normal brain activity that occurs in sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single dose administration
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: MelatoninMelatonin 0.3mg/kg (20mg max) |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Clinic Dx of DEE-SWAS
- Dx of DEE-SWAS by a board-certified pediatric neurology/epileptologist Clinical history of delayed milestones in at least 1 category, regression of milestones in at least 1 category, and/or failure to progress in milestones in at least 1 category
- Abnormal baseline neuropsychiatric testing consistent with Dx Abnormal EEG
- Epileptiform abnormalities (spike, polyspike, sharp) in at least 1 head region
- Increase by 2-fold of epileptiform abnormalities during NREM sleep as compared to wakefulness
Key exclusion criteria (7 listed)
- Allergic to ingredients in study drug Melatonin
- History of known cardiac rhythm abnormalities, heart failure or decreased EF <30%
- History of known pulm requiring oxygen or invasive positive pressure ventilation. Patients with non-invasive PPV (e.g. CPAP) due OSA w/o 02 requirement, rate, or DX of CSA, on stable pressure settings for >3 mnths will not be excluded.
- History of liver dysf OR AST/ALT/AlkPhos >2.5 ULN w/i year. If lab value meeting exclusion between 3-12 months, a repeat lab value < 2.5 ULN will be considered for inclusion
- Post-menarchal participants. of childbearing potential with a positive urine pregnancy test
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 |
|---|---|---|
| MelatoninMelatonin will be used in single fixed dose as described | Drug | Melatonin |
Primary outcome
Adverse Events
Time frame: Within 24 hours of dose administration
This study will evaluate for adverse events associated with single high dose melatonin administration
Side effects
Time frame: Within 24 hours of dose administration
This study will evaluate for multiorgan adverse effects associated with single high dose melatonin administration based on standardized questionnaire assessment. The assessment is a multiorgan adverse event questionnaire described in Jarernsiripornkul 2001, modified to reflect single dosing rather than chronic dosing. The results of this questionanaire are descriptive.
3 secondary outcomes
Spike wave index (SWI)
Time frame: Within 24 hours of dose administration
Sleep spindle
Time frame: Within 24 hours of dose administration
Salivary melatonin pharmacokinetics
Time frame: 24 hours prior to intervention and 24 hours following intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin in people with CSWS and Developmental and/or Epileptic Encephalopathies, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc..
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 30 Oct 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Adverse Events (time frame: Within 24 hours of dose administration). 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 30 Oct 2025.