Safety
anxiety, cataract, depression, ideation, convulsions, abdominal pain, TEAEs, insomnia, lethargy, nausea, fatigue, abnormal dreams, cataracts, dyspepsia, constipation, dizziness, headache, dry mouth, visual hallucination
CATARACT, DRUG WITHDRAWAL SYNDROME, ADVERSE EVENT, CATARACTS, DRY MOUTH, ATRIOVENTRICULAR BLOCK FIRST DEGREE
During part A, 14 participants (93.3%) in the soticlestat group and 9 participants (100.0%) in the placebo group reported at least one TEAE, with TEAEs considered to be related to the study drug by the investigator in 8 (53.3%) and 6 (66.7%) participants, respectively (Safety summary (safety analysis set)TEAE = treatment-emergent adverse event.Data are expressed as n (%).TEAEs considered to be related to treatment in Part A: abdominal pain (placebo, n = 1); abnormal dreams (soticlestat, n = 1); anxiety (placebo, n = 1); constipation (soticlestat, n = 1); disturbance in attention (placebo, n = 1); dizziness (soticlestat, n = 4; placebo, n = 2); dry mouth (soticlestat, n = 2); dyspepsia (soticlestat, n = 1); eosinophil count increased (soticlestat, n = 1); fatigue (soticlestat, n = 2); headache (soticlestat, n = 2; placebo, n = 4); insomnia (soticlestat, n = 2; placebo, n = 1); lethargy (soticlestat, n = 1; placebo, n = 1); nausea (soticlestat, n = 3; placebo, n = 1); and visual hallucination (placebo, n = 1). TEAEs considered to be related to treatment in Part B: atrioventricular block first degree (n = 1); cataract (n = 1); cataract cortical (n = 1); cataract subcapsular (n = 1); depression (n = 1); drug withdrawal syndrome (n = 1); headache (n = 2); insomnia (n = 1); and suicidal ideation (n = 1). Participants may have reported more than one TEAE.Psychosis, convulsions, and cataracts.Three participants (5.6%) were found to have mild cataracts: one participant who received placebo during part A was found to have lesions before starting soticlestat treatment in part B; one participant who received soticlestat during part A and part B had an ongoing mild lesion, thought to be a borderline age-related cataract; and one participant who received soticlestat during part A and part B had lesions reported at week 13 that were considered not significant and were likely related to age. None of the lesions affected visual acuity in any of the participants and none were considered to be clinically significant.A maximum post-baseline category of suicidal ideation according to the C-SSRS was recorded in two participants (11.1%) during part B.