Trial · NCT00965575
Pilot Study of Melatonin and Epilepsy
NCT00965575, Phase 2, Completed, Children's Hospital Medical Center, Cincinnati; results first posted 2020-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study of Melatonin and Epilepsy. Trials, record NCT00965575. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00965575
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Melatonin and Epilepsy
- NCT number
- NCT00965575
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Epilepsy
- Interventions
- Melatonin, Placebos
- First posted
- 2009-08-25
- Last updated
- 2020-10-01
- Results first posted
- 2020-10-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sleep Latency Wakefulness After Sleep Onset (WASO) | 13 weeks | Sleep Latency Wakefulness After Sleep Onset (WASO). Calculated as the sum of wake time minutes from sleep onset to the final awakening. |
| Secondary | Seizure Frequency | 13 weeks | Seizure frequency was determined by parent/caregiver report on a seizure diary which was filled out after each seizure which is an accepted patient-reported outcome measure. Data is given as number of seizures per month. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sleep Latency Wakefulness After Sleep Onset (WASO) | 13 weeks | minutes/night | MEAN | |
| SECONDARY | Seizure Frequency | 13 weeks | seizures/month | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sleep Latency Wakefulness After Sleep Onset (WASO) | Melatonin | 42.3 | Standard Deviation 30.3 | minutes/night | |
| Sleep Latency Wakefulness After Sleep Onset (WASO) | Placebo | 57.3 | Standard Deviation 31.6 | minutes/night | |
| Seizure Frequency | Melatonin | 1.4 | Standard Deviation 3.8 | seizures/month | |
| Seizure Frequency | Placebo | 2.4 | Standard Deviation 6.6 | seizures/month |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Melatonin First Then Placebo | 6 | |
| Overall Study | STARTED | Placebo First Then Melatonin | 5 | |
| Overall Study | COMPLETED | Melatonin First Then Placebo | 5 | |
| Overall Study | COMPLETED | Placebo First Then Melatonin | 5 | |
| Overall Study | NOT COMPLETED | Melatonin First Then Placebo | 1 | |
| Overall Study | NOT COMPLETED | Placebo First Then Melatonin | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Melatonin | 1 | 10 | |
| other | Headache | Nervous system disorders | Placebo | 0 | 10 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Melatonin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Melatonin | 1 | 10 |
| Total, other adverse events | Placebo | 0 | 10 |
| Total, serious adverse events | Melatonin | 0 | 10 |
| Total, serious adverse events | Placebo | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Melatonin vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00965575
GET https://conductscience.org/api/trials/v1/NCT00965575/registered