‘Cannabidiol was observed to be safe and well-tolerated for most patients with treatment-resistant epilepsy. Their seizure frequency was found to have dropped significantly.’

Dr. Devinsky said, "We are very encouraged by our trial results showing that CBD was safe and well-tolerated for most patients, and that seizures dropped significantly. But before we raise hopes for families who regularly deal with the devastation of treatment-resistant epilepsy, more research, including further studies through our ongoing randomized controlled trial, are needed to definitively recommend CBD as a treatment to patients with uncontrolled seizures."The study was an open-labeled trial, meaning that both the researchers and participants' families knew they were receiving CBD, a compound in medical marijuana that does not contain psychoactive properties. Between January 15, 2014, and January 15, 2015, 214 patients between 1 and 30 years of age with intractable, or treatment-resistant, epilepsy were enrolled in the trial. Of that cohort, 162 (76%) had at least 12 weeks of follow-up after the first dose of CBD and were included in the safety and tolerability analysis. In addition, 137 of the original study cohort (64%) were included in the analysis to determine the drug's efficacy.Patients were given an oral CBD regimen from 2-5 mg/kg per day, with a dose up-titrated until intolerance occurred or to a maximum dose of 25 mg/kg or 50 mg/kg per day, depending on the trial site. Seizures were recorded by parents or caregivers in diaries and reviewed by the study team at each visit.Lab screenings also were conducted at baseline, and after 4, 8 and 12 weeks of CBD treatment. The study showed variability in responses of individual seizure types to cannabidiol treatment. For example, the median change in total seizures was 34.6% , with the greatest reduction occurring in patients with focal and atonic seizures followed by tonic or tonic-clonic seizures. Two patients were free of all seizure types over the entire 12 weeks.Adverse events were reported among participants, including drowsiness, decreased appetite, diarrhea, fatigue and convulsion. Most were mild to moderate and transient, but 20 patients had serious adverse events related to CBD use - most commonly status epilepticus, or seizures that last too long or too close together. Five patients had to discontinue treatment due to these adverse events.Dr. Devinsky is currently leading a randomized, controlled trial - considered the gold standard of scientific research -in which CBD or a placebo is randomly assigned to patients to better tease out the drug's effects and better eliminate research bias.Dr. Devinsky cautions, "I empathize with parents who are looking for answers and will try anything to help their children suffering the devastating effects of intractable epilepsy. But we must let the science, and not anecdotal success stories and high media interest, lead this national discussion. Taking CBD in a controlled medical setting is vastly different from going to a state where medical marijuana is legal and experimenting with dosing and CBD strains."Source: Eurekalert