Epidiolex Clinical Trials

What are Epidiolex Clinical Trials?

Epidiolex is the brand name for cannabidiol (CBD). This compound is derived from cannabinoids, substances found in cannabis plants, such as marijuana. Manufactured by the British pharmaceutical company Jazz Pharmaceuticals it is sold under the brand name Epidyolex in Europe.

In 2018 it was FDA-approved for the treatment of severe epilepsy (seizures) in disorders such as Lennox-Gastaut syndrome (LGS), Dravet syndrome, and tuberous sclerosis complex (TSC). However, Epidiolex is also used to treat other neurological disorders, movement disorders, cognition, pain, anxiety, depression, and even cancer management. These other uses have not been approved by the FDA as there is currently insufficient clinical evidence to back their effectiveness for these claims.

Why Is Epidiolex Being Studied In Clinical Trials?

Medications like Eipdiolex are essential to managing rare childhood disorders like Lennox-Gastaut syndrome (LGS) and Dravet syndrome, which develop within the first year of life. 10 mg/kg/day doses have been shown to reduce seizures by 37% in LGS patients, and 20 mg/kg/day doses reduced episodes in 39% of Dravet patients.

Epidiolex is life-saving for such individuals and drastically improves their quality of life. However, this medication has many side effects, such as nausea, fever, yellowing, and pain. Its interaction with other medications and its long-term effects need to be studied to correctly determine its safety.

There is also a need for more clinical data on Eipdiolex’s medical effectiveness for other neurological disorders and mental illnesses, as there is no conclusive evidence of its effectiveness in either case.

There is also an increased interest in using CBD in veterinary medicine.

How Does Epidiolex Treatment Work?

The active ingredient in Epidiolex is cannabidiol (CBD). CBD is a non-intoxicating compound that interacts with receptors in the body's endocannabinoid system, such as CB1 and CB2. This system controls various body functions such as pain, movement, appetite, sleep, and inflammation.

This medication is taken as an oral solution or injectable starting at 2.5 mg/kg/day and is built up to 10 – 20 mg/kg/day, depending on the severity and frequency of seizures. Treatment can start on patients as young as the age of one.

What Are Some of the Breakthrough Clinical Trials Involving Epidiolex?

2019: A systematic review of the clinical data regarding the effects of cannabinoids, such as Epidioloex, in treating mental disorders. Results found minor improvements in conditions such as depression, anxiety, ADHD, PTSD, and psychosis, but not enough to justify their use. These findings directly counter the increased use of medicinal cannabis in treating such conditions and the widespread misinformation in their benefits.

2020: This review studied the clinical data of Epidiolex used on various disorders, from Lennox-Gastaut Syndrome to cognitive dysfunction. Conclusions found a great deal of discrepancy regarding the dosage and regulation of CBD medication. The fact that many of these trials were privately funded by the companies that develop the drugs suggests a bias in the results that did not disclose the adverse effects, such as diarrhea seen in a majority of participants.