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NCT02324673 · ClinicalTrials.gov registry record · Phase 1
Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders
A Phase 1 study of Seizures, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
- 10
- Study locations
NCT02324673: Completed Phase 1 study of Seizures, sponsored by INSYS Therapeutics.
NCT02324673 is a Phase 1 study of Seizures that has completed, run by INSYS Therapeutics. The registered enrollment target is 61 participants, below the 933-participant average among 39 other Seizures trials with a reported enrollment target (93% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02324673, a Phase 1 study of Seizures, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion. Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant seizures, and satisfy all inclusion/exclusion criteria.
Primary Outcome
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Conditions Studied
Interventions
- DRUG Cannabidiol Oral Solution
Study Locations (10)
Florida
- Miami Children's Hospital - Miami
- Child Neurology Center - NW F - Pensacola
California
- University of California San Francisco Medical Center - San Francisco
Illinois
- University of Chicago Medical Center - Chicago
Nevada
- Clinical Research Center of Nevada LLC - Las Vegas
Oregon
- Oregon Health Services University - Portland
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Tennessee
- Le Bonheur Children's Hospital - Memphis
Texas
- Texas Scottish Rite Hospital for Children - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2015-04-13 |
| Est. Completion | 2016-05-09 |
| Phase | Phase 1 |
What the finished NCT02324673 record still lists
NCT02324673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 933-participant average among 39 other Seizures trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Seizures appearing as the primary indexed condition, and to 1 intervention - of which Cannabidiol Oral Solution is the first listed.
NCT02324673 lists 10 locations in 9 states (Florida, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT02324673 about?
NCT02324673 is a clinical study titled "Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders". This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion. Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant s...
What is the current status of trial NCT02324673?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2015-04-13. Estimated completion is 2016-05-09.
What conditions does trial NCT02324673 study?
This clinical trial studies the following conditions: Seizures.
What interventions are being tested in trial NCT02324673?
The interventions under investigation include: Cannabidiol Oral Solution (DRUG).
Who is sponsoring clinical trial NCT02324673?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02324673 being conducted?
This trial has 10 study locations across California, Florida, Illinois, Nevada, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02324673's enrollment target sits among peer trials
61 22nd of 39 higher than 18 of 39 other Seizures trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Seizures 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.
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