NCT03686033 is a Phase 2 clinical trial of E2082 in Photosensitive Epilepsy, sponsored by Eisai Inc..

Who is sponsoring NCT03686033?

NCT03686033 is sponsored by Eisai Inc..

What drugs are being tested in NCT03686033?

Interventions in NCT03686033: Placebo, E2082.

What condition does NCT03686033 study?

NCT03686033 studies Photosensitive Epilepsy.

Is NCT03686033 still recruiting?

NCT03686033 is currently terminated. Last updated 28 September 2020.

Are results published for NCT03686033?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-09-28 · How we verify

NCT03686033

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Pharmacodynamic Activity of E2082 in Adult Participants With Photosensitive Epilepsy

Terminated Phase 2 Results posted Last updated 28 September 2020

What this trial tests

Phase 2 trial testing Placebo in Photosensitive Epilepsy in 8 participants. Terminated before completion.

Timeline

31 October 2018

Primary endpoint
18 June 2019

18 June 2019

Quick facts

Lead sponsor	Eisai Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	8
Start date	31 October 2018
Primary completion	18 June 2019
Estimated completion	18 June 2019
Sites	5 locations across United States

Drugs / interventions tested

Placebo
E2082 — full drug profile →

Conditions studied

Photosensitive Epilepsy — all drugs for Photosensitive Epilepsy →

Sponsor

Eisai Inc. — full company profile →

Who can join

Adults 18 to 60, any sex, with Photosensitive Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change From Baseline in the Photoparoxysmal Response (PPR) Range in the Most Sensitive Eye Condition at 8 Hours Postdose on Day 1 of Each Treatment Period Primary · Baseline (30 minutes-2 hours) and at 8 hours postdose on Day 1 of each treatment period

PPR was an electroencephalogram (EEG) trait of spike and spike-wave discharges in response to photic stimulation. Intermittent photic stimulation (IPS)-EEG assessments determine the range of frequencies of IPS that elicited an epileptiform EEG response. Each IPS-EEG assessment was conducted in all 3 eye conditions (eye closure, eyes closed, and eyes open) at ascending and then descending photo stimulation administered at 14 standard frequencies: 2, 5, 8, 10, 13, 15, 18, 20, 23, 25, 30, 40, 50, and 60 hertz (Hz). The lower and upper limit of photosensitivity to IPS threshold frequency were dete

Baseline

Group	Value	95% CI
Treatment A: Placebo	6.80	± 4.604
Treatment B: E2082 2.5 mg	5.60	± 4.336
Treatment C: E2082 25 mg	6.00	± 3.651
Open-label Treatment: E2082 40 mg	6.50	± 1.732

Change at 8 hours postdose

Group	Value	95% CI
Treatment A: Placebo	0.00	± 1.517
Treatment B: E2082 2.5 mg	1.16	± 1.381
Treatment C: E2082 25 mg	-3.90	± 2.928
Open-label Treatment: E2082 40 mg	-5.25	± 0.957

Mean Change From Baseline in PPR Ranges in Each of the 3 Eye Conditions (Eye Closure, Eyes Closed, and Eyes Opened) at 8 Hours Postdose on Day 1 of Each Treatment Period Secondary · Baseline (30 minutes-2 hours) and at 8 hours postdose on Day 1 of each treatment period

PPR was an EEG trait of spike and spike-wave discharges in response to photic stimulation. IPS-EEG assessments determine the range of frequencies of IPS that elicited an epileptiform EEG response. Each IPS-EEG assessment was conducted in all 3 eye conditions (eye closure, eyes closed, and eyes open) at ascending and then descending photo stimulation administered at 14 standard frequencies: 2, 5, 8, 10, 13, 15, 18, 20, 23, 25, 30, 40, 50, and 60 Hz. The lower and upper limit of photosensitivity to IPS threshold frequency were determined for each eye condition. From this range, SPR was derived.

Eye Closure: Baseline

Group	Value	95% CI
Treatment A: Placebo	6.2	± 4.09
Treatment B: E2082 2.5 mg	6	± 3.87
Treatment C: E2082 25 mg	5.8	± 4.65
Open-label Treatment: E2082 40 mg	5.5	± 2.89

Eye Closure: Change at 8 hours postdose

Group	Value	95% CI
Treatment A: Placebo	0.6	± 1.66
Treatment B: E2082 2.5 mg	0.4	± 0.91
Treatment C: E2082 25 mg	-3.7	± 3.93
Open-label Treatment: E2082 40 mg	-4.3	± 1.71

Eyes Closed: Baseline

Group	Value	95% CI
Treatment A: Placebo	5.4	± 4.72
Treatment B: E2082 2.5 mg	5.6	± 4.72
Treatment C: E2082 25 mg	5.3	± 3.2
Open-label Treatment: E2082 40 mg	6.3	± 2.87

Eyes Closed: Change at 8 hours postdose

Group	Value	95% CI
Treatment A: Placebo	1.1	± 1.4
Treatment B: E2082 2.5 mg	0.7	± 1.56
Treatment C: E2082 25 mg	-3.7	± 2.96
Open-label Treatment: E2082 40 mg	-5.4	± 1.62

Eyes Open: Baseline

Group	Value	95% CI
Treatment A: Placebo	5.2	± 5.4
Treatment B: E2082 2.5 mg	4.6	± 4.04
Treatment C: E2082 25 mg	5	± 3.83
Open-label Treatment: E2082 40 mg	6.3	± 4.65

Eyes Open: Change at 8 hours postdose

Group	Value	95% CI
Treatment A: Placebo	0.5	± 2.18
Treatment B: E2082 2.5 mg	0.8	± 1.12
Treatment C: E2082 25 mg	-3.9	± 3.28
Open-label Treatment: E2082 40 mg	-5.8	± 4.09

Time to Onset of Mean Photosensitivity Response in Each of the 3 Eye Conditions (Eye Closure, Eyes Closed, and Eyes Open Condition) up to 8 Hours Postdose on Day 1 of Each Treatment Period Secondary · Baseline (30 minutes-2 hours) up to 8 hours postdose on Day 1 of each treatment period

Time to onset of mean photosensitivity response in each of the 3 eye conditions (eye closure, eyes closed, and eyes open condition) was determined from mean and mean change from baseline SPR data across participants. The onset of mean suppression was defined as the first time point at which the mean Response of standardized photosensitivity response (SPR) across participants (not for each participant) was at least 3 units below the mean SPR at baseline. Photosensitivity response were essentially intermittent photosensitivity (intermittent photic stimulation \[IPS\]) assessments, is a form of v

Eye Closure

Group	Value	95% CI
Treatment A: Placebo	NA
Treatment B: E2082 2.5 mg	NA
Treatment C: E2082 25 mg	1
Open-label Treatment: E2082 40 mg	1

Eyes Closed

Group	Value	95% CI
Treatment A: Placebo	NA
Treatment B: E2082 2.5 mg	NA
Treatment C: E2082 25 mg	1
Open-label Treatment: E2082 40 mg	1

Eyes Opened

Group	Value	95% CI
Treatment A: Placebo	NA
Treatment B: E2082 2.5 mg	NA
Treatment C: E2082 25 mg	1
Open-label Treatment: E2082 40 mg	1

Maximum Change From Baseline of Photosensitivity Response in Each of the 3 Eye Conditions (Eye Closure, Eyes Closed, and Eyes Open Condition) up to 8 Hours Postdose on Day 1 of Each Treatment Period Secondary · Baseline (30 minutes-2 hours) up to 8 hours postdose on Day 1 of each treatment period

Maximum change from baseline of photosensitivity response in each of the 3 eye conditions (eye closure, eyes closed, and eyes open condition) were reported. PPR was an EEG trait of spike and spike-wave discharges in response to photic stimulation. IPS-EEG assessments determine the range of frequencies of IPS that elicited an epileptiform EEG response. Each IPS-EEG assessment was conducted in all 3 eye conditions (eye closure, eyes closed, and eyes open) at ascending and then descending photo stimulation administered at 14 standard frequencies: 2, 5, 8, 10, 13, 15, 18, 20, 23, 25, 30, 40, 50, a

Eye Closure: Baseline

Group	Value	95% CI
Treatment A: Placebo	6.20	± 4.087
Treatment B: E2082 2.5 mg	6.00	± 3.873
Treatment C: E2082 25 mg	5.75	± 4.646
Open-label Treatment: E2082 40 mg	5.50	± 2.887

Eye Closure: Maximum Change

Group	Value	95% CI
Treatment A: Placebo	1.40	± 3.912
Treatment B: E2082 2.5 mg	1.80	± 2.588
Treatment C: E2082 25 mg	-4.50	± 3.697
Open-label Treatment: E2082 40 mg	-5.25	± 2.500

Eyes Closed: Baseline

Group	Value	95% CI
Treatment A: Placebo	5.40	± 4.722
Treatment B: E2082 2.5 mg	5.60	± 4.722
Treatment C: E2082 25 mg	5.25	± 3.202
Open-label Treatment: E2082 40 mg	6.25	± 2.872

Eyes Closed: Maximum Change

Group	Value	95% CI
Treatment A: Placebo	1.80	± 2.588
Treatment B: E2082 2.5 mg	2.00	± 2.345
Treatment C: E2082 25 mg	-4.25	± 2.630
Open-label Treatment: E2082 40 mg	-6.25	± 2.872

Eyes Opened: Baseline

Group	Value	95% CI
Treatment A: Placebo	5.20	± 5.404
Treatment B: E2082 2.5 mg	4.60	± 4.037
Treatment C: E2082 25 mg	5.00	± 3.830
Open-label Treatment: E2082 40 mg	6.25	± 4.646

Eyes Opened: Maximum Change

Group	Value	95% CI
Treatment A: Placebo	2.00	± 3.240
Treatment B: E2082 2.5 mg	1.80	± 3.633
Treatment C: E2082 25 mg	-4.25	± 3.304
Open-label Treatment: E2082 40 mg	-6.25	± 4.646

Duration of Mean Photosensitivity Response in Each of the 3 Eye Conditions (Eye Closure, Eyes Closed, and Eyes Open Condition) up to 8 Hours Postdose on Day 1 of Each Treatment Period Secondary · Baseline (30 minutes-2 hours) up to 8 hours postdose on Day 1 of each treatment period

Duration of mean photosensitivity response in each of the 3 eye conditions (eye closure, eyes closed, and eyes open condition) was determined from mean and mean change from baseline SPR data across participants. Duration of mean suppression was defined as the difference in hours between the onset of mean suppression and the end of mean suppression of photosensitivity across participants. The onset of mean suppression was defined as the first time point at which the mean SPR across participants was at least 3 units below the mean SPR at baseline. The end of mean suppression was defined as the l

Eye Closure: Duration

Group	Value	95% CI
Treatment A: Placebo	NA
Treatment B: E2082 2.5 mg	NA
Treatment C: E2082 25 mg	7
Open-label Treatment: E2082 40 mg	7

Eyes Closed: Duration

Group	Value	95% CI
Treatment A: Placebo	NA
Treatment B: E2082 2.5 mg	NA
Treatment C: E2082 25 mg	7
Open-label Treatment: E2082 40 mg	7

Eyes Opened: Duration

Group	Value	95% CI
Treatment A: Placebo	NA
Treatment B: E2082 2.5 mg	NA
Treatment C: E2082 25 mg	7
Open-label Treatment: E2082 40 mg	7

Number of Participants With Complete Suppression, Partial Response, and no Response of Standardized Photosensitivity Response (SPR) up to 8 Hours Postdose on Day 1 of Each Treatment Period Secondary · Baseline (30 minutes-2 hours) up to 8 hours postdose on Day 1 of each treatment period

Complete suppression, reduction (partial response), and no change (no response) of PPR will be measured. Complete suppression was defined as a SPR reduction to 0 over at least 1 time point for all three eye conditions. Partial response was defined as a reduction in SPR of at least 3 units from baseline for at least 3 time points, and no time points with at least 3 units of increase, in the most sensitive eye condition; without meeting the complete suppression definition. No response was defined as not meeting complete suppression or partial suppression definitions.

Complete Suppression

Group	Value	95% CI
Treatment A: Placebo	0
Treatment B: E2082 2.5 mg	0
Treatment C: E2082 25 mg	2
Open-label Treatment: E2082 40 mg	2

Partial Response

Group	Value	95% CI
Treatment A: Placebo	0
Treatment B: E2082 2.5 mg	0
Treatment C: E2082 25 mg	0
Open-label Treatment: E2082 40 mg	2

No Response

Group	Value	95% CI
Treatment A: Placebo	5
Treatment B: E2082 2.5 mg	5
Treatment C: E2082 25 mg	2
Open-label Treatment: E2082 40 mg	0

Change From Baseline in Bond and Lader Visual Analogue Scales (BL-VAS) at 1, 2, 4, 6, and 8 Hours Post-dose in Each Treatment Period Secondary · Baseline (30 minutes-2 hours) and at 1,2,4,6 and 8 hours post-dose in each treatment period

BL-VAS system was used to assess the extent of damage to the extrapyramidal system and the motor functions that it controls. The BL-VAS monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 millimeter (mm) about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three subscales: a.) Anxiety, b.) Dysphoria, c.) sedation with each item ranges from 0 to 100 and higher scores

Anxiety: Baseline

Group	Value	95% CI
Treatment A: Placebo	29.42	± 22.731
Treatment B: E2082 2.5 mg	29.42	± 22.731
Treatment C: E2082 25 mg	24.33	± 22.712
Open-label Treatment: E2082 40 mg	24.33	± 22.712

Anxiety: Change at 1 hour post-dose

Group	Value	95% CI
Treatment A: Placebo	-7.36	± 23.099
Treatment B: E2082 2.5 mg	-9.44	± 19.550
Treatment C: E2082 25 mg	-0.37	± 0.386
Open-label Treatment: E2082 40 mg	-2.40	± 3.382

Anxiety: Change at 2 hours post-dose

Group	Value	95% CI
Treatment A: Placebo	2.84	± 8.996
Treatment B: E2082 2.5 mg	-10.04	± 20.028
Treatment C: E2082 25 mg	-1.05	± 2.684
Open-label Treatment: E2082 40 mg	19.73	± 42.748

Anxiety: Change at 4 hours post-dose

Group	Value	95% CI
Treatment A: Placebo	2.82	± 8.885
Treatment B: E2082 2.5 mg	-8.96	± 18.512
Treatment C: E2082 25 mg	0.10	± 1.010
Open-label Treatment: E2082 40 mg	-0.10	± 4.017

Anxiety: Change at 6 hours post-dose

Group	Value	95% CI
Treatment A: Placebo	-0.72	± 3.883
Treatment B: E2082 2.5 mg	-9.70	± 21.895
Treatment C: E2082 25 mg	-0.87	± 2.766
Open-label Treatment: E2082 40 mg	-0.42	± 4.452

Anxiety: Change at 8 hours post-dose

Group	Value	95% CI
Treatment A: Placebo	-0.72	± 3.935
Treatment B: E2082 2.5 mg	5.92	± 43.792
Treatment C: E2082 25 mg	18.78	± 35.818
Open-label Treatment: E2082 40 mg	-0.85	± 3.171

Dysphoria: Baseline

Group	Value	95% CI
Treatment A: Placebo	33.58	± 23.032
Treatment B: E2082 2.5 mg	33.58	± 23.032
Treatment C: E2082 25 mg	36.23	± 25.703
Open-label Treatment: E2082 40 mg	36.23	± 25.703

Dysphoria: Change at 1 hour post-dose

Group	Value	95% CI
Treatment A: Placebo	-4.44	± 7.134
Treatment B: E2082 2.5 mg	-0.50	± 6.536
Treatment C: E2082 25 mg	0.50	± 0.883
Open-label Treatment: E2082 40 mg	2.28	± 4.110

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Secondary · Up to 28 days after the last dose of study treatment on Day 1 in Treatment Period 4 (approximately Day 71)

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Group	Value	95% CI
Treatment A: Placebo	2
Treatment B: E2082 2.5 mg	2
Treatment C: E2082 25 mg	1
Open-label Treatment: E2082 40 mg	2

Number of Participants With Clinically Significant Change From Baseline in Vital Signs Secondary · Up to 28 days after the last dose of study treatment on Day 1 in Treatment Period 4 (approximately Day 71)

Group	Value	95% CI
Treatment A: Placebo	0
Treatment B: E2082 2.5 mg	0
Treatment C: E2082 25 mg	0
Open-label Treatment: E2082 40 mg	0

Number of Participants With Clinically Significant Change From Baseline in Laboratory Values Secondary · Up to 28 days after the last dose of study treatment on Day 1 in Treatment Period 4 (approximately Day 71)

Group	Value	95% CI
Treatment A: Placebo	0
Treatment B: E2082 2.5 mg	0
Treatment C: E2082 25 mg	0
Open-label Treatment: E2082 40 mg	0

Cmax: Maximum Observed Plasma Concentration for E2082 Secondary · Predose (within 2 hours prior to dosing) to 8 hours postdose on Day 1 of each treatment period

Group	Value	95% CI
Treatment B: E2082 2.5 mg	100	± 25.1
Treatment C: E2082 25 mg	617	± 30.3
Open-label Treatment: E2082 40 mg	851	± 91.8

Tmax: Time to Reach Maximum Plasma Concentration (Cmax) for E2082 Secondary · Predose (within 2 hours prior to dosing) to 8 hours postdose on Day 1 of each treatment period

Group	Value	95% CI
Treatment B: E2082 2.5 mg	3.93	1.00 – 7.82
Treatment C: E2082 25 mg	3.96	3.90 – 4.00
Open-label Treatment: E2082 40 mg	3.99	1.88 – 7.88

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 28 days after the last dose of study treatment on Day 1 in Treatment Period 4 (approximately Day 71). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment A: Placebo

Serious: 1/5 (20%)

Deaths: 0/5

Treatment B: E2082 2.5 mg

Serious: 0/5 (0%)

Deaths: 0/5

Treatment C: E2082 25 mg

Serious: 0/4 (0%)

Deaths: 0/4

Open-label Treatment: E2082 40 mg

Serious: 0/4 (0%)

Deaths: 0/4

Serious adverse events (3 terms)

Reaction	System	Treatment A: Placebo	Treatment B: E2082 2.5 mg	Treatment C: E2082 25 mg	Open-label Treatment: E208…
Eye movement disorder	Eye disorders	—	—	—	—
Disturbance in attention	Nervous system disorders	—	—	—	—
Dysarthria	Nervous system disorders	—	—	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Treatment A: Placebo	Treatment B: E2082 2.5 mg	Treatment C: E2082 25 mg	Open-label Treatment: E208…
Somnolence	Nervous system disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Dysarthria	Nervous system disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Aggression	Psychiatric disorders	—	—	—	—
Anger	Psychiatric disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Most-reported serious reactions: Eye movement disorder, Disturbance in attention, Dysarthria.

Data from ClinicalTrials.gov NCT03686033 adverse events section.

Sponsor's own description

The primary purpose of the study is to assess pharmacodynamic (PD) activity of E2082 as measured by suppression of epileptic photoparoxysmal response (PPR) in the participant's most sensitive eye condition in participants with photosensitive epilepsy, compared to placebo.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of E2082

Trials testing the same drug.

NCT03402178 — Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2082 in Healthy Male Subjects · Phase 1 · terminated

Other Eisai Inc. trials

Trials by the same sponsor.

NCT07493265 — A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy · Phase 2 · not yet recruiting
NCT07308236 — A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants · Phase 1 · recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease · Phase 2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03686033 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
Last refreshed: 28 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03686033.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing