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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 is a Phase 2 study that was terminated before completion, run by INSYS Therapeutics. The registered enrollment target is 9 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02551731
The ClinicalTrials.gov registry entry for NCT02551731 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is INSYS Therapeutics, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cannabidiol Oral Solution is the first listed.
NCT02551731 reports 0 study locations.
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.
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