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NCT02695537 · ClinicalTrials.gov registry record · Phase 1
University of Alabama at Birmingham (UAB) Pediatric CBD Program
A Phase 1 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
NCT02695537: Completed Phase 1 study, sponsored by University of Alabama at Birmingham.
NCT02695537 is a Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 89 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02695537, a Phase 1 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating debilitating, drug-resistant epilepsy.
Primary Outcome
Severe adverse events (SAEs) were defined as increase in seizure frequency by more than 100% leading to emergency room visit or hospitalization. During study clinic and phone visits, adverse and severe adverse event monitoring and reporting were assessed among all participants. Data was recorded and stored in the UAB RedCap System.
Interventions
- DRUG Epidiolex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-02-27 |
| Phase | Phase 1 |
What the finished NCT02695537 record still lists
NCT02695537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher).
The record links to 0 conditions, and to 1 intervention - of which Epidiolex is the first listed.
NCT02695537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02695537 about?
NCT02695537 is a clinical study titled "University of Alabama at Birmingham (UAB) Pediatric CBD Program". The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating debilitating, drug-resistant epilepsy.
What is the current status of trial NCT02695537?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2015-04. Estimated completion is 2019-02-27.
What interventions are being tested in trial NCT02695537?
The interventions under investigation include: Epidiolex (DRUG).
Who is sponsoring clinical trial NCT02695537?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02695537's enrollment target sits among peer trials
89 649th of 2000 higher than 1,351 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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