Trial · NCT04572243

A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome

NCT04572243, Phase 3, Terminated, Eisai Inc.; results first posted 2025-10-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome. Trials, record NCT04572243. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04572243

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
NCT number: NCT04572243
Status: Terminated
Phases: Phase 3
Enrollment: 22 participants, actual
Lead sponsor: Eisai Inc.
Conditions: Epilepsies, Myoclonic
Interventions: Placebo, Lorcaserin
First posted: 2020-10-01
Last updated: 2025-10-08
Results first posted: 2025-10-08
Limitations and caveats: This study was terminated due to sponsor decision, and not due to safety concerns.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period	Baseline up to Week 14	Seizure frequency for convulsive seizures was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and 14-week treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28. Percent change from baseline was calculated as: (\[post-baseline value minus the baseline value\] / baseline value) \*100.
Secondary	Core Study: Percentage of Participants With 50% or Greater Response for Convulsive Seizures in the Treatment Period Compared to Baseline	Baseline up to Week 14	A responder was defined as a participant who experienced a reduction of 50% or greater in the frequency of convulsive seizures during the 14-week treatment period compared to the baseline period (Week -4 to Week 0). Seizure frequency was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28.
Secondary	Core Study: Percentage of Participants Who Were Free From Convulsive Seizures in the Treatment Period	Baseline up to Week 14	A responder was a participant who experienced a 100% reduction (seizure freedom) in convulsive seizure frequency in the 14-week treatment period relative to the baseline period (Week -4 to Week 0). Seizure frequency was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28.
Secondary	Core Study: Plasma Concentrations of Lorcaserin	Weeks 1, 2, 6, 15: Pre-dose and 1 to 2 hours post-dose; Weeks 4,10: Pre-dose, 1 to 2 hours and 3 to 6 hours post-dose	Plasma Concentrations of Lorcaserin was evaluated and reported.
Secondary	Core Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18)	A TEAE was defined as an adverse event (AE) that emerges during treatment, was absent at pretreatment (baseline) or reemerges during treatment, was present at pretreatment (baseline) but stopped before treatment or worsens in severity during treatment relative to the pretreatment state, when the AE was continuous. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE did not necessarily have a causal relationship with the medicinal product.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period	Baseline up to Week 14	The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement.	percent change	MEDIAN
SECONDARY	Core Study: Percentage of Participants With 50% or Greater Response for Convulsive Seizures in the Treatment Period Compared to Baseline	Baseline up to Week 14	The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement.	percentage of participants	NUMBER
SECONDARY	Core Study: Percentage of Participants Who Were Free From Convulsive Seizures in the Treatment Period	Baseline up to Week 14	The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement.	percentage of participants	NUMBER
SECONDARY	Core Study: Plasma Concentrations of Lorcaserin	Weeks 1, 2, 6, 15: Pre-dose and 1 to 2 hours post-dose; Weeks 4,10: Pre-dose, 1 to 2 hours and 3 to 6 hours post-dose	The Pharmacokinetic (PK) analysis set was the group of all randomized participants from whom at least measurable lorcaserin plasma concentration was obtained with associated documented dosing history. Here 'n' refers to number of participants analyzed at different timepoints for this outcome measure.	nanograms per milliliter (ng/mL)	MEAN
SECONDARY	Core Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18)	The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period	Core Study: Placebo		18.78	Full Range -53.7 to 131.5	percent change
Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period	Core Study: Lorcaserin		-78.88	Full Range -100.0 to 542.9	percent change
Core Study: Percentage of Participants With 50% or Greater Response for Convulsive Seizures in the Treatment Period Compared to Baseline	Core Study: Placebo		20.0		percentage of participants
Core Study: Percentage of Participants With 50% or Greater Response for Convulsive Seizures in the Treatment Period Compared to Baseline	Core Study: Lorcaserin		60.0		percentage of participants
Core Study: Percentage of Participants Who Were Free From Convulsive Seizures in the Treatment Period	Core Study: Placebo		0.0		percentage of participants
Core Study: Percentage of Participants Who Were Free From Convulsive Seizures in the Treatment Period	Core Study: Lorcaserin		10.0		percentage of participants
Core Study: Plasma Concentrations of Lorcaserin	Core Study: Lorcaserin	Week 1: Pre-dose	52.0	Standard Deviation NA	nanograms per milliliter (ng/mL)
Core Study: Plasma Concentrations of Lorcaserin	Core Study: Lorcaserin	Week 1: 1 to 2 hours post-dose	106	Standard Deviation NA	nanograms per milliliter (ng/mL)
Core Study: Plasma Concentrations of Lorcaserin	Core Study: Lorcaserin	Week 2: Pre-dose	22.1	Standard Deviation 14.5	nanograms per milliliter (ng/mL)
Core Study: Plasma Concentrations of Lorcaserin	Core Study: Lorcaserin	Week 2: 1 to 2 hours post-dose	32.7	Standard Deviation 22.7	nanograms per milliliter (ng/mL)

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow28

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Core Study: 14 Weeks	STARTED	Core Study: Placebo	11
Core Study: 14 Weeks	STARTED	Core Study: Lorcaserin	11
Core Study: 14 Weeks	STARTED	Extension Phase: Placebo Then Lorcaserin	0
Core Study: 14 Weeks	STARTED	Extension Phase: Lorcaserin	0
Core Study: 14 Weeks	Treated	Core Study: Placebo	10
Core Study: 14 Weeks	Treated	Core Study: Lorcaserin	11
Core Study: 14 Weeks	Treated	Extension Phase: Placebo Then Lorcaserin	0
Core Study: 14 Weeks	Treated	Extension Phase: Lorcaserin	0
Core Study: 14 Weeks	COMPLETED	Core Study: Placebo	8
Core Study: 14 Weeks	COMPLETED	Core Study: Lorcaserin	7

1 to 10 of 28Source ClinicalTrials.gov

See all 28 participant flow

Adverse events124

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Dacryostenosis acquired	Eye disorders	Core Study: Placebo	0	10
other	Dacryostenosis acquired	Eye disorders	Core Study: Lorcaserin	1	11
other	Dacryostenosis acquired	Eye disorders	Extension Phase: Placebo Then Lorcaserin	0	7
other	Dacryostenosis acquired	Eye disorders	Extension Phase: Lorcaserin	0	7
other	Constipation	Gastrointestinal disorders	Core Study: Placebo	0	10
other	Constipation	Gastrointestinal disorders	Core Study: Lorcaserin	1	11
other	Constipation	Gastrointestinal disorders	Extension Phase: Placebo Then Lorcaserin	0	7
other	Constipation	Gastrointestinal disorders	Extension Phase: Lorcaserin	0	7
other	Fatigue	General disorders	Core Study: Placebo	0	10
other	Fatigue	General disorders	Core Study: Lorcaserin	1	11

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Core Study: Placebo	0	10
Total, all-cause mortality	Core Study: Lorcaserin	0	11
Total, all-cause mortality	Extension Phase: Placebo Then Lorcaserin	0	7
Total, all-cause mortality	Extension Phase: Lorcaserin	0	7
Total, other adverse events	Core Study: Placebo	7	10
Total, other adverse events	Core Study: Lorcaserin	8	11
Total, other adverse events	Extension Phase: Placebo Then Lorcaserin	4	7
Total, other adverse events	Extension Phase: Lorcaserin	3	7
Total, serious adverse events	Core Study: Placebo	0	10
Total, serious adverse events	Core Study: Lorcaserin	1	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Core Study: Lorcaserin vs Core Study: Placebo: Core Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04572243

GET https://conductscience.org/api/trials/v1/NCT04572243/results?page=2

API reference For AI assistants