No significant difference in efficacy was observed between cannabidiol and placebo during the double-blind treatment period. Few participants discontinued (7% ), and most (98% ) continued into the open-label extension.Ĭonclusions and Relevance Both doses of transdermal cannabidiol were well tolerated and safe. Treatment-emergent adverse events occurred in 50.4% (63 of 125 participants) of the cannabidiol group vs 41.3% (26 of 63 participants) in the placebo group, with a treatment difference of 9.1% (95% CI, −6.0% to 23.6%), and occurred at similar rates in the cannabidiol groups. By month 6 of the open-label extension, 115 patients (60.8%) achieved a seizure reduction of at least 50%. At week 12 of the double-blind period, there was no difference in seizure frequency between placebo (mean 2.49 seizures per 28 days) and 195-mg cannabidiol (mean 2.51 seizures per 28 days least squares mean difference, 0.014 95% CI, −0.175 to 0.203 P = .89) or 390-mg cannabidiol (mean 2.59 seizures per 28 days least squares mean difference, 0.096 95% CI, −0.093 to 0.285 P = .32). Results A total of 188 patients (45% male and 54.8% female ) with a mean (SD) age of 39.2 (12.78) years were randomized, treated, and analyzed (195-mg cannabidiol, 63 participants 390-mg cannabidiol, 62 participants placebo, 63 participants).
The primary efficacy end point was the least squares mean difference in the log-transformed total seizure frequency per 28-day period, adjusted to a common baseline log seizure rate, during the 12-week treatment period. Main Outcomes and Measures Seizure frequency was self-reported using a daily diary. Interventions Eligible participants were randomized (1:1:1) to 195-mg or 390-mg transdermal cannabidiol or placebo daily for 12 weeks, after which they could enroll in an open-label extension study for up to 2 years. Data were analyzed from July 2017 to November 2018. Participants were adults with drug-resistant focal epilepsy receiving a stable regimen of up to 3 antiseizure medications.
VICTORIA 3 DEVELOPMENT DIARY TRIAL
Objective To investigate the efficacy, safety, and tolerability of transdermally administered cannabidiol in adults with drug-resistant focal epilepsy.ĭesign, Setting, and Participants A randomized, double-blind, placebo-controlled, multicenter clinical trial at 14 epilepsy trial centers in Australia and New Zealand. However, high-level evidence for the efficacy and safety of cannabidiol in the most common form of drug-resistant epilepsy in adults, focal epilepsy, is lacking. Importance Cannabidiol has shown efficacy in randomized clinical trials for drug-resistant epilepsy in specific syndromes that predominantly affect children. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.
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