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Enrolled participants (n = 7) with paroxysmal response to intermittent photic stimulation were randomly assigned to receive single doses of CVL-865 17.5 mg or 52.5 mg, lorazepam (active control), or placebo in a 4-period crossover design. After dosing, standardized photosensitivity ranges (SPRs) to IPS were measured at 0, 1, 2, 4, and 6 hours. The primary endpoint was the average least change in SPR in participants’ most sensitive eye condition.
Treatment with either CVL-865 or lorazepam produced a statistically significant reduction in SPR compared to placebo. Of the participants, 6 (86%) who received CVL-865 or lorazepam had complete suppression of IPS, and 5 (71%) who received placebo had no response.
“We are encouraged by the robust anticonvulsant activity of CVL-865 observed in this type of clinical study, which has shown to be predictive of treatment success in broader epilepsy patient populations,” said Raymond Sanchez, MD, chief medical officer at Cerevel Therapeutics. “We look forward to further evaluating the potential of CVL-865 to treat people living with epilepsy who do not respond to currently available therapies.”
A novel α2/3/5-subtype selective GABAApositive allosteric modulator, CVL-865 was formerly called PF-06372865.