Trials / Completed
CompletedNCT02324673
Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders
A Phase 1/2 Study to Assess the Pharmacokinetics and Safety of Multiple Doses of Pharmaceutical Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Seizure Disorders
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- INSYS Therapeutics Inc · Industry
- Sex
- All
- Age
- 1 Year – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cannabidiol Oral Solution | An oral solution containing pharmaceutical grade cannabidiol (nonplant-based). |
Timeline
- Start date
- 2015-04-13
- Primary completion
- 2016-05-09
- Completion
- 2016-05-09
- First posted
- 2014-12-24
- Last updated
- 2017-06-23
- Results posted
- 2017-06-23
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02324673. Inclusion in this directory is not an endorsement.