Cannabidiol Medication Trial Returns Positive Results

Epidiolex CBD trial

A medication based on the cannabinoid CBD (cannabidiol) has again proven to be useful in managing a rare form of epilepsy according to a recent trial.

GW Pharmaceuticals announced positive results from the first randomized, double-blind, placebo-controlled Phase 3 clinical trial of its Epidiolex medicine for the treatment of Lennox-Gastaut syndrome (LGS).

During the trial, patients taking Epidiolex experienced a median reduction in monthly “drop seizures” of 44 percent compared with a reduction of 22 percent in patients receiving a placebo; a difference the company says was statistically significant.

Drop seizures are defined as those involving the entire body, trunk or head that could result in a fall, injury, slumping in a chair or the patient hitting their head on a surface.

The medication wasn’t without some side-effects, with the most common events occurring Epidiolex-treated patients being diarrhea, somnolence, decreased appetite, pyrexia, and vomiting. However,  78 percent reported such events to be mild or moderate. It’s important to note that 69 percent of patients on the placebo also reported experiencing adverse events.

Twenty patients taking the Epidiolex experienced a serious adverse event and nine of these were deemed to be related to treatment. Four patients taking the placebo experienced an adverse event.

“From a physician’s perspective, the positive outcome in this trial of Epidiolex in patients with Lennox-Gastaut syndrome is very exciting,” said  Dr. Linda Laux, an investigator in the trial with a number of significant professional associations.

“Lennox-Gastaut syndrome begins in early childhood, is particularly difficult to treat, and the vast majority of patients do not obtain an adequate response from existing therapies.”

A second Phase 3 dose-ranging trial of Epidiolex for the treatment of Lennox-Gastaut syndrome is under way and initial results are expected towards the end of the third quarter of this year.

In March this year, GW Pharmaceuticals announced positive results from a Phase 3 study of the use of Epidiolex in patients suffering Dravet syndrome, also known as severe myoclonic epilepsy of infancy (SMEI).

Last week, the company announced it had selected infantile spasms (IS) as the fourth target condition for its Epidiolex orphan pediatric epilepsy development program. IS currently has limited treatment options and children suffering from the condition experience higher mortality rates, cognitive and developmental delay.

Cannabidiol is one of the many cannabinoids that occurs naturally in the cannabis plant. It is a non-intoxicating compound that is also believed to offer benefits in treating a number of other conditions, including multiple sclerosis.