Steve Chung, MD

“The good news, again, is there weren’t any surprising side effects that we did not know about…in that sense, it is a very positive study showing sustained safety of this medication.”

Findings of an interim analysis of the phase 3 GWPCARE6 open-label extension trial (NCT02544750) of GW Pharmaceuticals’ cannabidiol (CBD; Epidiolex) were accepted for presentation at the 

American Academy of Neurology (AAN) 2020 Annual Meeting

 that demonstrated the therapy’s well-tolerated profile in patients with tuberous sclerosis complex (TSC) across a long-term treatment period.

Adverse events (AEs) were documented in 93% of patients, with 15% experiencing a serious AE, and 6% discontinuing due to AEs. The most common AEs, occurring in >20% of patients, were diarrhea, seizure, and decreased appetite, which were observed in 42%, 22%, and 20%, respectively. There was 1 death in the study deemed unrelated to treatment. The authors also noted that elevated alanine aminotransferase (ALT)/aspartate aminotransferase (AST) more than 3 times the upper limit of normal were reported in 8.5% (n = 17), with 12 of those patients on concomitant valproate.

To gain some outside perspective on how these data were interpreted in the clinical community, 

 spoke with Steve Chung, MD, neurologist, Banner-University Medicine Neuroscience Institute, who was not affiliated with the study, who shared his thoughts on the data and discussed what promise CBD might hold in the treatment of TSC.

Thiele E, Bebin EM, Filloux F, et al. Long-term safety and efficacy of cannabidiol (CBD) for the treatment of seizures in patients with tuberous sclerosis complex (TSC) in an open-label extension (OLE) trial (GWPCARE6). 

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The neurologist at Banner-University Medicine Neuroscience Institute offered his perspective on data from an open-label safety assessment of cannabidiol (Epidiolex) in the treatment of tuberous sclerosis complex.

Steve Chung, MD: Cannabidiol in Tuberous Sclerosis Complex

“We now have some information from this poster that [perampanel] could benefit those people [with epilepsy] who already have anxiety disorder or anxiety symptoms in that it may improve their sleep and reduce insomnia.”

Results from a study analyzing the effect of perampanel (Fycompa; Eisai) that were accepted to be presented the 

 suggest it may improve insomnia by decreasing anxiety in patients with epilepsy. Furthermore, the findings imply that the drug should be considered for treating patients who suffer from both insomnia and anxiety.

, Steve Chung, MD, neurologist, Banner-University Medicine Neuroscience Institute, who was not affiliated with the study, shared his thoughts on this finding, particularly noting that it helps improve the physician understanding of the Eisai agent. Chung noted that many neurologists and epileptologists describe that despite the fact that it works on a broad spectrum and has once-daily convenient dosing, the fear having or previously reported behavioral adverse effects have acted as a roadblock to choosing perampanel as a treatment.

The data showed perampanel to be associated with lowered Insomnia Severity Index (ISI) scores in patients with anxiety (

 = .001) but did not demonstrate a significant effect in those without anxiety (

 = .431). There was a clinically significant interaction between anxiety-by-perampanel and insomnia on the analysis of covariance (

 = .029). To find out more about what these data mean for clinicians, 

Jung M, Jo S, Kim HJ, et al. Perampanel May Improve Insomnia Through a Decrease in Anxiety in Patients with Epilepsy. 

The neurologist at Banner-University Medicine Neuroscience Institute discussed the findings of a study that suggest perampanel may improve insomnia by decreasing anxiety in patients with epilepsy.

Author | Steve Chung, MD

Articles

Steve Chung, MD: Cannabidiol in Tuberous Sclerosis Complex

Steve Chung, MD: Perampanel's Effect on Insomnia in Patients With Epilepsy