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NCT02318602 · ClinicalTrials.gov registry record · Phase 3
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
A Phase 3 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
NCT02318602: Completed Phase 3 study, sponsored by INSYS Therapeutics.
NCT02318602 is a Phase 3 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 52 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02318602, a Phase 3 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
Study Summary
This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS). All participants have rolled over from previous trials: INS011-14-029 (NCT02324673) and INS011-15-054 (NCT02551731).
Primary Outcome
An Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment.
Interventions
- DRUG Cannabidiol Oral Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2016-01-08 |
| Est. Completion | 2017-06-22 |
| Phase | Phase 3 |
What the finished NCT02318602 record still lists
NCT02318602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 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.
NCT02318602 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02318602 about?
NCT02318602 is a clinical study titled "Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder". This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS). All participants have rolled ...
What is the current status of trial NCT02318602?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2016-01-08. Estimated completion is 2017-06-22.
What interventions are being tested in trial NCT02318602?
The interventions under investigation include: Cannabidiol Oral Solution (DRUG).
Who is sponsoring clinical trial NCT02318602?
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 NCT02318602's enrollment target sits among peer trials
52 1841st of 2000 higher than 159 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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