An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

Jazz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Seizures; Tuberous Sclerosis Complex

Treatments: Drug: GWP42003-P

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02544750

2015-002154-12 (EudraCT Number)

GWEP1521 Open-Label Extension

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Ages: 1 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Completion of the GWEP1521 Blinded Phase

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

199 participants in 1 patient group

GWP42003-P

Experimental group

Description:

100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening). Participants will be dosed up to a maximum of 50 mg/kg/day. Dose may be lower if Investigator judges benefit and/or tolerability issues.

Treatment:

Drug: GWP42003-P