Trial Outcomes & Findings for Pilot Study of Melatonin and Epilepsy (NCT NCT00965575)

NCT ID: NCT00965575

Last Updated: 2020-10-01

Results Overview

Sleep Latency Wakefulness After Sleep Onset (WASO). Calculated as the sum of wake time minutes from sleep onset to the final awakening.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: 13 weeks
• Results posted on: 2020-10-01

Participant Flow

recruitment was done from cincinnati children's neurology/epilepsy clinics during the period of June 2011 to Dec 2012.

Actual enrollment was 11. 10 completed the study

Participant milestones

Measure	Melatonin First Then Placebo Subjects will take sustained release melatonin 30 minutes prior to bedtime for four weeks Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects. Cross over, so subjects who received melatonin in the first phase will receive placebo during the second phase and vice versa.	Placebo First Then Melatonin Subjects will take a placebo 30 minutes before bedtime for four weeks Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects. Cross over, so subjects who received melatonin in the first phase will receive placebo during the second phase and vice versa.
Overall Study STARTED	6	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Melatonin First Then Placebo Subjects will take sustained release melatonin 30 minutes prior to bedtime for four weeks Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects. Cross over, so subjects who received melatonin in the first phase will receive placebo during the second phase and vice versa.	Placebo First Then Melatonin Subjects will take a placebo 30 minutes before bedtime for four weeks Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects. Cross over, so subjects who received melatonin in the first phase will receive placebo during the second phase and vice versa.
Overall Study subject unwillingness to swallow study c	1	0

Baseline Characteristics

Pilot Study of Melatonin and Epilepsy

Baseline characteristics by cohort

Measure	Melatonin First Then Placebo n=6 Participants Subjects will take sustained release melatonin 30 minutes prior to bedtime for four weeks Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects.	Placebo First Then Melatonin n=5 Participants Subjects will take a placebo 30 minutes before bedtime for four weeks Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks

Sleep Latency Wakefulness After Sleep Onset (WASO). Calculated as the sum of wake time minutes from sleep onset to the final awakening.

Outcome measures

Measure	Melatonin n=10 Participants Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects. Taken 30 minutes prior to bedtime.	Placebo n=10 Participants Placebo: taken 30 minutes prior to bedtime
Sleep Latency Wakefulness After Sleep Onset (WASO)	42.3 minutes/night Standard Deviation 30.3	57.3 minutes/night Standard Deviation 31.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Melatonin n=10 Participants Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects. Taken 30 minutes prior to bedtime.	Placebo n=10 Participants Placebo: taken 30 minutes prior to bedtime
Seizure Frequency	1.4 seizures/month Standard Deviation 3.8	2.4 seizures/month Standard Deviation 6.6

Adverse Events

Melatonin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Melatonin n=10 participants at risk Subjects will take sustained release melatonin 30 minutes prior to bedtime for four weeks Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects.	Placebo n=10 participants at risk Subjects will take a placebo 30 minutes before bedtime for four weeks Melatonin: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects.
Nervous system disorders Headache	10.0% 1/10	0.00% 0/10

Additional Information

Sejal Jain

Cincinnti Childrens

Phone: 513-636-4222

Email: sejal.jain@cchmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place