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NCT02551731 · ClinicalTrials.gov registry record · Phase 2
Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms
A Phase 2 study, sponsored by INSYS Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT02551731: Clinical Trial Phase 2 study, sponsored by INSYS Therapeutics.
NCT02551731 is a Phase 2 study that was terminated before completion, run by INSYS Therapeutics. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02551731, a Phase 2 study, was terminated before completion, sponsored by INSYS Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy that usually strikes children in the first year of life. There is a great need for safe and effective therapies in the treatment of IS. This need is even more important for infants and toddlers still sick after being treated with medicine that is already available. This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral Solution (CBD) in the treatment of children aged 6 months through 36 months with a diagnosis of infantile spasms who have not responded to first line therapies. The overall study duration is expected to be 64 weeks for those subjects who respond to CBD treatment. The maximum possible study duration for each patient is approximately 64 weeks, however a subject will be deemed to have completed the study after 58 weeks.
Primary Outcome
Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-electroencephalogram (EEG) at Day 14.
Interventions
- DRUG Cannabidiol Oral Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2016-01-27 |
| Est. Completion | 2016-09-06 |
| Phase | Phase 2 |
Why NCT02551731 stopped before completion
NCT02551731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Cannabidiol Oral Solution is the first listed.
NCT02551731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02551731 about?
NCT02551731 is a clinical study titled "Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms". Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy that usually strikes children in the first year of life. There is a great need for safe and effective therapies in the treatment of IS. This need is even more important for infants and toddlers still sick a...
What is the current status of trial NCT02551731?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2016-01-27. Estimated completion is 2016-09-06.
What interventions are being tested in trial NCT02551731?
The interventions under investigation include: Cannabidiol Oral Solution (DRUG).
Who is sponsoring clinical trial NCT02551731?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02551731's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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