Long-term cannabidiol treatment for seizures in patients with tuberous sclerosis complex: An open-label extension trial.

ABSTRACT:

Objective

To evaluate the long-term safety and efficacy of add-on cannabidiol (CBD) in patients with seizures associated with tuberous sclerosis complex (TSC) in the open-label extension (OLE) of the randomized, placebo-controlled phase 3 trial GWPCARE6 (NCT02544763). Results of an interim (February 2019 data cut) analysis are reported.

Methods

Patients who completed the randomized trial enrolled to receive CBD (Epidiolex^® in the United States; Epidyolex^® in the EU; 100 mg/mL oral solution). The initial target dose was 25 mg/kg/day, which, based on response and tolerability, could be decreased or increased up to 50 mg/kg/day. The primary end point was safety. Key secondary end points included percentage reduction in TSC-associated (countable focal and g

SUBMITTER: Thiele EA 

PROVIDER: S-EPMC9305454 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature