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NCT01700959 · ClinicalTrials.gov registry record · Phase 3
Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
A Phase 3 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 911
- Enrollment target
NCT01700959: Completed Phase 3 study, sponsored by St. Jude Children's Research Hospital.
NCT01700959 is a Phase 3 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 911 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01700959, a Phase 3 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 911 participants
- Enrollment target
Study Summary
Primary objective: 1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer. Secondary objectives: 1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors. 2. To investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors. This study is a randomized double-blind placebo controlled trial of time release melatonin for adult survivors of childhood cancer who demonstrate impaired neurocognitive functioning and/or difficulty falling asleep.
Primary Outcome
Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.
Interventions
- DRUG placebo
- DRUG melatonin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 911 participants |
| Start Date | 2013-02-06 |
| Est. Completion | 2017-04-19 |
| Phase | Phase 3 |
What the finished NCT01700959 record still lists
NCT01700959 is an interventional study that assigns participants to a tested intervention. The registered 911 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01700959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01700959 about?
NCT01700959 is a clinical study titled "Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort". Primary objective: 1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer. Secondary objectives: 1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors. 2. To investi...
What is the current status of trial NCT01700959?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 911 participants. The study started on 2013-02-06. Estimated completion is 2017-04-19.
What interventions are being tested in trial NCT01700959?
The interventions under investigation include: placebo (DRUG), melatonin (DRUG).
Who is sponsoring clinical trial NCT01700959?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01700959's enrollment target sits among peer trials
911 347th of 2000 higher than 1,654 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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