Trials / Completed
CompletedNCT03467113
A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol
An Open-Label Trial to Assess the Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Combination With Cannabidiol, as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered cannabidiol (CBD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ZX008 0.2 to 0.8 mg/kg/day | ZX008 drug is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free. |
| DRUG | Cannabidiol | Cannabidiol |
Timeline
- Start date
- 2018-01-19
- Primary completion
- 2020-06-24
- Completion
- 2020-06-24
- First posted
- 2018-03-15
- Last updated
- 2023-12-01
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03467113. Inclusion in this directory is not an endorsement.