Trial Outcomes & Findings for Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures (NCT NCT01397968)

Last Updated: 2022-04-11

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

222 participants

Primary outcome timeframe

assessed per 28 days during 12 week period; change from baseline and 12 weeks reported

Results posted on

2022-04-11

Participant Flow

Enrollment occurred in 4 countries (United States, Poland, Korea, India) between 06 July 2011 and 15 June 2013 when the last subject completed the double-blind period.

There were 285 patients screened; 63 were excluded before assignment to study group for reasons as follows: inclusion/exclusion criteria, withdrew by patient, other, lost to follow-up.

Participant milestones

Participant milestones
Measure	YKP3089 YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day	Placebo Placebo: capsule, dose to be titrated to a target dose of 200mg/day
Double-blind Period of Study YKP3089C013 STARTED	113	109
Double-blind Period of Study YKP3089C013 COMPLETED	102	99
Double-blind Period of Study YKP3089C013 NOT COMPLETED	11	10
Open-label Extension Study YKP3089C013 STARTED	76	73
Open-label Extension Study YKP3089C013 COMPLETED	40	37
Open-label Extension Study YKP3089C013 NOT COMPLETED	36	36

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	YKP3089 n=113 Participants YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day	Placebo n=109 Participants Placebo: capsule, dose to be titrated to a target dose of 200mg/day	Total n=222 Participants Total of all reporting groups
Age, Continuous	36 Years n=99 Participants	38 Years n=107 Participants	37 Years n=206 Participants
Sex: Female, Male Female	58 Participants n=99 Participants	51 Participants n=107 Participants	109 Participants n=206 Participants
Sex: Female, Male Male	55 Participants n=99 Participants	58 Participants n=107 Participants	113 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	105 Participants n=99 Participants	101 Participants n=107 Participants	206 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants	5 Participants n=107 Participants	9 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	49 Participants n=99 Participants	45 Participants n=107 Participants	94 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) White	57 Participants n=99 Participants	58 Participants n=107 Participants	115 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants	4 Participants n=107 Participants	8 Participants n=206 Participants
Region of Enrollment South Korea	22 participants n=99 Participants	19 participants n=107 Participants	41 participants n=206 Participants
Region of Enrollment United States	43 participants n=99 Participants	43 participants n=107 Participants	86 participants n=206 Participants
Region of Enrollment Poland	22 participants n=99 Participants	22 participants n=107 Participants	44 participants n=206 Participants
Region of Enrollment India	26 participants n=99 Participants	25 participants n=107 Participants	51 participants n=206 Participants
28-day partial-onset seizure frequency	7.5 seizures/28 days n=99 Participants	5.5 seizures/28 days n=107 Participants	6.5 seizures/28 days n=206 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	YKP3089 n=113 Participants YKP3089: Capsule, dose to be titrated Tablet, dose to be titrated	Placebo n=108 Participants Placebo: Placebo capsule Placebo tablet
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days	55.6 percent seizure reduction Interval -417.3 to 100.0	21.5 percent seizure reduction Interval -588.0 to 100.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	YKP3089 n=113 Participants YKP3089: Capsule, dose to be titrated Tablet, dose to be titrated	Placebo n=108 Participants Placebo: Placebo capsule Placebo tablet
50% Responder Rate	57 Participants	24 Participants

Adverse Events

YKP3089

Serious events: 3 serious events

Other events: 86 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	YKP3089 n=113 participants at risk YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day	Placebo n=109 participants at risk Placebo: capsule, dose to be titrated to a target dose of 200mg/day
Immune system disorders Drug hypersensitivity reaction	0.88% 1/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	0.00% 0/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Infections and infestations Urinary tract infection	0.88% 1/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	0.00% 0/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Nervous system disorders Status epilepticus	0.88% 1/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	1.8% 2/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Nervous system disorders Convulsion	0.00% 0/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	0.92% 1/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Investigations Arteriogram coronary normal	0.00% 0/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	0.92% 1/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)

Other adverse events

Additional Information

Chief Medical Officer

SK Life Science

Phone: 201-421-3830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	YKP3089 n=113 participants at risk YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day	Placebo n=109 participants at risk Placebo: capsule, dose to be titrated to a target dose of 200mg/day
Nervous system disorders Somnolence	22.1% 25/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	11.9% 13/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Nervous system disorders Dizziness	22.1% 25/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	16.5% 18/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Nervous system disorders Headache	12.4% 14/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	12.8% 14/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Gastrointestinal disorders Nausea	11.5% 13/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	4.6% 5/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
General disorders Fatigue	10.6% 12/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	6.4% 7/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Nervous system disorders Nystagmus	9.7% 11/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	0.00% 0/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Nervous system disorders Balance disorder	8.0% 9/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	0.92% 1/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Infections and infestations Urinary tract infection	8.0% 9/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	1.8% 2/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Infections and infestations Upper respiratory tract infection	7.1% 8/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	4.6% 5/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Nervous system disorders Tremor	6.2% 7/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	2.8% 3/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Infections and infestations Nasopharyngitis	6.2% 7/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	0.92% 1/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Gastrointestinal disorders Constipation	5.3% 6/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	0.00% 0/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Gastrointestinal disorders Diarrhea	5.3% 6/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	0.00% 0/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Gastrointestinal disorders Vomiting	5.3% 6/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	1.8% 2/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)
Psychiatric disorders Anxiety	0.88% 1/113 • 12 week double-blind treatment period plus taper period (2-3 weeks)	5.5% 6/109 • 12 week double-blind treatment period plus taper period (2-3 weeks)