A Study to Evaluate the Pharmacodynamic Activity of E2730 in Adult Participants With Photosensiti… (NCT03603639) | Clinical Trial Compass
TerminatedPhase 2
A Study to Evaluate the Pharmacodynamic Activity of E2730 in Adult Participants With Photosensitive Epilepsy
Stopped: The study was stopped due to efficacy reasons.
United States6 participantsStarted 2018-07-27
Plain-language summary
The primary purpose of the study is to assess the pharmacodynamic (PD) activity of E2730 as measured by suppression of epileptic photoparoxysmal response (PPR) in the participant's most sensitive eye condition in participants with photosensitive epilepsy.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Male or female 18 to 60 years old at the time of informed consent.
✓. A diagnosis and history of a PPR on EEG with or without a diagnosis of epilepsy.
✓. Currently taking up to a maximum of 3 concomitant antiepileptic drugs (AEDs). If taking concomitant AED(s), the dose must have remained stable for at least 4 weeks prior to Screening.
✓. A reproducible intermittent photic stimulation (IPS)-induced PPR on EEG of at least 3 points on a frequency assessment scale (SPR) in at least 1 eye condition on at least 3 of the EEGs performed at Screening.
✓. A body mass index (BMI) between 18 to 35 kilogram per square meter (kg/m\^2) and a total body weight greater than or equal to 45 kilograms (kg) at the time of Screening.
Exclusion criteria
✕. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[ß-hCG\] (or human chorionic gonadotropin \[hCG\]) test with a minimum sensitivity of 25 international units per liter \[IU/L\] or equivalent units of ß-hCG \[or hCG\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
✕. History of nonepileptic seizures (eg, metabolic, structural, or pseudoseizures) while on any antiepileptic medication(s).
✕. History of status epilepticus while on any antiepileptic medication(s) within 2 years prior to Screening.
✕. Ongoing or history of generalized tonic-clonic seizures within 6 months prior to Screening.
What they're measuring
1
Mean Change From Baseline in the Standard Photosensitivity Response (SPR) in the Most Sensitive Eye Condition at 8 Hours Post-dose on Day 1 of Each Treatment Period
Timeframe: Baseline (30 minutes-2 hours) pre-dose and at 8 hours post-dose on Day 1 of each treatment period
✕. Previously developed or who experienced a clinical seizure during prior PPR assessment or Screening IPS procedure, respectively.
✕. Use of AEDs that affect gama-aminobutyric acid (GABA) (GABAergic AEDs) (such as tiagabine, vigabatrin, gabapentin, pregabalin) within 3 months prior to Screening.
✕. Multiple drug allergies or a severe drug reaction to AED(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
✕. An active central nervous system (CNS) infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results.