Trial · NCT01866111

A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

NCT01866111, Phase 2, Completed, SK Life Science, Inc.; results first posted 2022-04-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures. Trials, record NCT01866111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01866111

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Trial

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

Title: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
NCT number: NCT01866111
Status: Completed
Phases: Phase 2
Enrollment: 437 participants, actual
Lead sponsor: SK Life Science, Inc.
Conditions: Partial Epilepsy
Interventions: YKP3089, Placebo
First posted: 2013-05-31
Last updated: 2025-06-24
Results first posted: 2022-04-29

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days	baseline and 18 weeks	Percent change in complex partial and/or secondarily generalized and/or simple partial motor seizure frequency per 28 days (average 28-day seizure rate) in each treatment group during the double-blind period relative to the pretreatment baseline.
Secondary	50% Responder Rate	18 weeks	Percentage of patients achieving a 50% or more reduction from baseline in partial seizure frequency during the double-blind treatment period

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days	baseline and 18 weeks	All randomly assigned patients who took at least one dose of study drug and had any post-baseline seizure data.	percent change	MEDIAN
SECONDARY	50% Responder Rate	18 weeks	All randomly assigned patients who had taken at least one dose of study drug and had any post-baseline seizure data	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days	Placebo	-24.0	Full Range -91 to 198	percent change
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days	Cenobamate 100 mg/Day	-35.5	Full Range -100 to 206	percent change
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days	Cenobamate 200 mg/Day	-55.0	Full Range -100 to 191	percent change
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days	Cenobamate 400 mg/Day	-55.0	Full Range -100 to 167	percent change
50% Responder Rate	Placebo	23		Participants
50% Responder Rate	Cenobamate 100 mg/Day	44		Participants
50% Responder Rate	Cenobamate 200 mg/Day	63		Participants
50% Responder Rate	Cenobamate 400 mg/Day	67		Participants

Source ClinicalTrials.gov

Participant flow24

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

Period	Milestone	Group	Participants
Double-blind Period of Study YKP3089C017	STARTED	Placebo	108
Double-blind Period of Study YKP3089C017	STARTED	Cenobamate 100 mg/Day	108
Double-blind Period of Study YKP3089C017	STARTED	Cenobamate 200 mg/Day	110
Double-blind Period of Study YKP3089C017	STARTED	Cenobamate 400 mg/Day	111
Double-blind Period of Study YKP3089C017	COMPLETED	Placebo	94
Double-blind Period of Study YKP3089C017	COMPLETED	Cenobamate 100 mg/Day	95
Double-blind Period of Study YKP3089C017	COMPLETED	Cenobamate 200 mg/Day	90
Double-blind Period of Study YKP3089C017	COMPLETED	Cenobamate 400 mg/Day	81
Double-blind Period of Study YKP3089C017	NOT COMPLETED	Placebo	14
Double-blind Period of Study YKP3089C017	NOT COMPLETED	Cenobamate 100 mg/Day	13

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events1,328

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	Somnolence	Nervous system disorders	Placebo	9	108
other	Somnolence	Nervous system disorders	Cenobamate 100 mg/Day	20	108
other	Somnolence	Nervous system disorders	Cenobamate 200 mg/Day	23	110
other	Somnolence	Nervous system disorders	Cenobamate 400 mg/Day	41	111
other	Somnolence	Nervous system disorders	100mg/Day Open-Label Extension	24	95
other	Somnolence	Nervous system disorders	200mg/Day Open-Label Extension	29	90
other	Somnolence	Nervous system disorders	400mg/Day Open-Label Extension	26	70
other	Somnolence	Nervous system disorders	Placebo Open-Label Extension	32	80
other	Dizziness	Nervous system disorders	Placebo	15	108
other	Dizziness	Nervous system disorders	Cenobamate 100 mg/Day	19	108

1 to 10 of 1,328Source ClinicalTrials.gov

See all 1,328 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	108
Total, all-cause mortality	Cenobamate 100 mg/Day	0	108
Total, all-cause mortality	Cenobamate 200 mg/Day	0	110
Total, all-cause mortality	Cenobamate 400 mg/Day	0	111
Total, all-cause mortality	100mg/Day Open-Label Extension	1	95
Total, all-cause mortality	200mg/Day Open-Label Extension	3	90
Total, all-cause mortality	400mg/Day Open-Label Extension	3	80
Total, all-cause mortality	Placebo Open-Label Extension	2	91
Total, other adverse events	Placebo	76	108
Total, other adverse events	Cenobamate 100 mg/Day	70	108

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25769377	DERIVED	PubMed
31734103	DERIVED	PubMed
33662894	DERIVED	PubMed
35705501	DERIVED	PubMed

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 comparisons0

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

None in this release.

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.

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