Phase 3
N=199
An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
Tuberous Sclerosis Complex · Seizures
Bottom Line
View on ClinicalTrials.gov: NCT02544750 ↗Enrolled (actual)
199
Serious AEs
28.1%
Results posted
Jul 2022
Primary outcome: Primary: Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) — 117; 75; 80; 60 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GWP42003-P (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) |
117; 75; 80; 60; 11; 7 | — |
| PRIMARY Number of Participants With Any TEAE, by Severity |
35; 16; 63; 48; 19; 11 | — |
| SECONDARY Percent Change From Baseline in the Number of TSC-associated Seizures During the OLE Treatment Period |
-55.66; -46.76 | — |
| SECONDARY Number of Participants Considered Treatment Responders During the OLE Treatment Period |
70; 36; 54; 39 | — |
| SECONDARY Caregiver Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC) Score During the OLE Treatment Period |
3.2; 3.4; 4.0; 2.7; 3.2; 3.3 | — |
| SECONDARY Percent Change From Baseline in Total Seizure Frequency During the OLE Treatment Period |
-55.18; -46.76 | — |
Summary
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.
Eligibility Criteria
Key Inclusion Criteria
- Completion of the GWEP1521 Blinded Phase
Data sourced from ClinicalTrials.gov (NCT02544750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.