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NCT01397968

Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

Completed Phase 2 Results posted
What this trial tests

Phase 2 trial testing YKP3089 in Partial Epilepsy in 222 participants. Completed in 28 January 2021.

Timeline
6 July 2011
28 January 2021

Quick facts

Lead sponsorSK Life Science, Inc.
PhasePhase 2
StatusCompleted
Enrollment222
Start date6 July 2011
Estimated completion28 January 2021

Drugs / interventions tested

Conditions studied

Sponsor

SK Life Science, Inc. — full company profile →

Who can join

Eligibility, any sex, with Partial Epilepsy.

Results — posted to ClinicalTrials.gov

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

Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days Primary · assessed per 28 days during 12 week period; change from baseline and 12 weeks reported

Percent change in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline

GroupValue95% CI
YKP308955.6-417.3 – 100.0
Placebo21.5-588.0 – 100.0
50% Responder Rate Secondary · 12 weeks

Greater than or equal to 50% reduction in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline.

GroupValue95% CI
YKP308957
Placebo24

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 week double-blind treatment period plus taper period (2-3 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

YKP3089
Serious: 3/113 (3%)
Deaths: 0/113
Placebo
Serious: 4/109 (4%)
Deaths: 0/109

Serious adverse events (5 terms)

ReactionSystemYKP3089Placebo
Status epilepticusNervous system disorders
Drug hypersensitivity reactionImmune system disorders
Urinary tract infectionInfections and infestations
ConvulsionNervous system disorders
Arteriogram coronary normalInvestigations
Other adverse events (15 terms — click to expand)

ReactionSystemYKP3089Placebo
SomnolenceNervous system disorders
DizzinessNervous system disorders
HeadacheNervous system disorders
NauseaGastrointestinal disorders
FatigueGeneral disorders
NystagmusNervous system disorders
Balance disorderNervous system disorders
Urinary tract infectionInfections and infestations
Upper respiratory tract infectionInfections and infestations
TremorNervous system disorders
NasopharyngitisInfections and infestations
ConstipationGastrointestinal disorders
DiarrheaGastrointestinal disorders
VomitingGastrointestinal disorders
AnxietyPsychiatric disorders

Most-reported serious reactions: Status epilepticus, Drug hypersensitivity reaction, Urinary tract infection, Convulsion, Arteriogram coronary normal.

Data from ClinicalTrials.gov NCT01397968 adverse events section.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures.
    Chung SS, French JA, Kowalski J, Krauss GL, et al · · 2020 · cited 175× · PMID 32409485 · DOI 10.1212/wnl.0000000000009530
  2. Post hoc analysis of a phase 3, multicenter, open-label study of cenobamate for treatment of uncontrolled focal seizures: Effects of dose adjustments of concomitant antiseizure medications.
    Rosenfeld WE, Abou-Khalil B, Aboumatar S, Bhatia P, et al · · 2021 · cited 49× · PMID 34633074 · DOI 10.1111/epi.17092
  3. Long-term safety of adjunctive cenobamate in patients with uncontrolled focal seizures: Open-label extension of a randomized clinical study.
    French JA, Chung SS, Krauss GL, Lee SK, et al · · 2021 · cited 49× · PMID 34254673 · DOI 10.1111/epi.17007
  4. Efficacy of cenobamate for uncontrolled focal seizures: Post hoc analysis of a Phase 3, multicenter, open-label study.
    Sperling MR, Abou-Khalil B, Aboumatar S, Bhatia P, et al · · 2021 · cited 47× · PMID 34633084 · DOI 10.1111/epi.17091
  5. Suppression of the photoparoxysmal response in photosensitive epilepsy with cenobamate (YKP3089).
    Kasteleijn-Nolst Trenite DGA, DiVentura BD, Pollard JR, Krauss GL, et al · · 2019 · cited 37× · PMID 31292226 · DOI 10.1212/wnl.0000000000007894
  6. Cenobamate in refractory epilepsy: Overview of treatment options and practical considerations.
    Schmitz B, Lattanzi S, Vonck K, Kälviäinen R, et al · · 2023 · cited 29× · PMID 37743544 · DOI 10.1002/epi4.12830
  7. Is Cenobamate the Breakthrough We Have Been Wishing for?
    Specchio N, Pietrafusa N, Vigevano F. · · 2021 · cited 18× · PMID 34502246 · DOI 10.3390/ijms22179339
  8. Onset of efficacy and adverse events during Cenobamate titration period.
    Steinhoff BJ, Ben-Menachem E, Brandt C, García Morales I, et al · · 2022 · cited 15× · PMID 35711112 · DOI 10.1111/ane.13659

Verify or expand the search:

Other trials of YKP3089

Trials testing the same drug.

Other recruiting trials for Partial Epilepsy

Currently open trials in the same condition.

Other SK Life Science, Inc. trials

Trials by the same sponsor.

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Data sources for this page

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