Trial Outcomes & Findings for Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures (NCT NCT02535091)

Last Updated: 2024-05-14

Results Overview

TEAEs were defined as Adverse events (AEs) with onset on or after the start of study medication, up to last dose date of study medication + 14 days or onset before study medication and worsened after starting study medication, up to last dose date of study medication + 14 days.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1345 participants

Primary outcome timeframe

1 day to up to 215 weeks after first dose.

Results posted on

2024-05-14

Participant Flow

Discrepancies can be found in the Protocol Enrollment number and the Participant Flow data. This discrepancy can be explained by the understanding that the Protocol Enrollment number refers to all participants that signed an informed consent form, while the Participant Flow data only takes into account participants that were dosed with at least one dose of study drug.

Participant milestones

Participant milestones
Measure	YKP3089 and Phenytoin Subjects taking phenytoin and cenobamate.	YKP3089 and Phenobarbital Subjects taking phenobarbital and cenobamate.	YKP3089 and Other AEDs Subjects taking AEDs other than phenobarbital and phenytoin and taking cenobamate.
Overall Study STARTED	83	37	1220
Overall Study COMPLETED	22	5	236
Overall Study NOT COMPLETED	61	32	984

Reasons for withdrawal

Reasons for withdrawal
Measure	YKP3089 and Phenytoin Subjects taking phenytoin and cenobamate.	YKP3089 and Phenobarbital Subjects taking phenobarbital and cenobamate.	YKP3089 and Other AEDs Subjects taking AEDs other than phenobarbital and phenytoin and taking cenobamate.
Overall Study Entered Expanded Access Program (EAP)/Navigator	34	18	575
Overall Study Withdrawal by Subject	14	5	121
Overall Study Adverse Event	9	4	170
Overall Study Other	4	3	81
Overall Study Lost to Follow-up	0	1	19
Overall Study Protocol Violation	0	1	11
Overall Study Pregnancy	0	0	7

Baseline Characteristics

Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	YKP3089 and Phenytoin n=83 Participants Subjects taking phenytoin and cenobamate.	YKP3089 and Phenobarbital n=37 Participants Subjects taking phenobarbital and cenobamate.	YKP3089 and Other AEDs n=1220 Participants Subjects taking AEDs other than phenobarbital and phenytoin and taking cenobamate.	Total n=1340 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants	35 Participants n=7 Participants	1187 Participants n=5 Participants	1298 Participants n=4 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	2 Participants n=7 Participants	33 Participants n=5 Participants	42 Participants n=4 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	15 Participants n=7 Participants	624 Participants n=5 Participants	667 Participants n=4 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	22 Participants n=7 Participants	596 Participants n=5 Participants	673 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=5 Participants	0 Participants n=7 Participants	50 Participants n=5 Participants	59 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	6 Participants n=7 Participants	65 Participants n=5 Participants	73 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	42 Participants n=5 Participants	47 Participants n=4 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants	28 Participants n=7 Participants	991 Participants n=5 Participants	1065 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants	2 Participants n=7 Participants	67 Participants n=5 Participants	90 Participants n=4 Participants
Height	170.42 cm STANDARD_DEVIATION 11.365 • n=5 Participants	167.92 cm STANDARD_DEVIATION 10.064 • n=7 Participants	169.31 cm STANDARD_DEVIATION 10.257 • n=5 Participants	169.34 cm STANDARD_DEVIATION 10.322 • n=4 Participants
Weight	80.82 kg STANDARD_DEVIATION 21.489 • n=5 Participants	75.91 kg STANDARD_DEVIATION 16.882 • n=7 Participants	77.11 kg STANDARD_DEVIATION 18.442 • n=5 Participants	77.30 kg STANDARD_DEVIATION 18.612 • n=4 Participants
Body Mass Index (BMI)	27.69 kg/m^2 STANDARD_DEVIATION 6.126 • n=5 Participants	26.78 kg/m^2 STANDARD_DEVIATION 5.280 • n=7 Participants	26.87 kg/m^2 STANDARD_DEVIATION 5.993 • n=5 Participants	26.92 kg/m^2 STANDARD_DEVIATION 5.982 • n=4 Participants

PRIMARY outcome

Timeframe: 1 day to up to 215 weeks after first dose.

Outcome measures

Outcome measures
Measure	YKP3089 and Phenytoin n=83 Participants Subjects taking phenytoin and cenobamate.	YKP3089 and Phenobarbital n=37 Participants Subjects taking phenobarbital and cenobamate.	YKP3089 and Other AEDs n=1220 Participants Subjects taking AEDs other than phenobarbital and phenytoin and taking cenobamate.	Safety Population All subjects enrolled in the study who received at least 1 dose of study drug medication were considered safety evaluable subjects.
Summary of Treatment-Emergent Adverse Events (TEAEs) TEAE with outcome of death	1 participants	0 participants	5 participants	—
Summary of Treatment-Emergent Adverse Events (TEAEs) At least 1 TEAE	76 participants	35 participants	1104 participants	—
Summary of Treatment-Emergent Adverse Events (TEAEs) At least 1 treatment-related TEAE	57 participants	29 participants	923 participants	—
Summary of Treatment-Emergent Adverse Events (TEAEs) TEAE leading to study drug discontinuation	9 participants	6 participants	168 participants	—
Summary of Treatment-Emergent Adverse Events (TEAEs) At least 1 serious TEAE	15 participants	6 participants	217 participants	—
Summary of Treatment-Emergent Adverse Events (TEAEs) At least 1 severe TEAE	10 participants	4 participants	148 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day to up to 215 weeks after first dose.

Subjects with At Least 1 Post-Baseline Measurement Meeting Abnormal Criteria. Changes in systolic and diastolic blood pressure, pulse rate, respiratory rate, temperature, weight, and height in each safety evaluable group were small and not clinically meaningful.

Outcome measures

Outcome measures
Measure	YKP3089 and Phenytoin n=83 Participants Subjects taking phenytoin and cenobamate.	YKP3089 and Phenobarbital n=37 Participants Subjects taking phenobarbital and cenobamate.	YKP3089 and Other AEDs n=1220 Participants Subjects taking AEDs other than phenobarbital and phenytoin and taking cenobamate.	Safety Population n=1340 Participants All subjects enrolled in the study who received at least 1 dose of study drug medication were considered safety evaluable subjects.
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Diastolic blood pressure >100 mmHg	7 participants	2 participants	68 participants	77 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Body weight: Increase of ≥7% from baseline	19 participants	5 participants	272 participants	296 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Respiratory rate >20 breaths/min	22 participants	6 participants	247 participants	275 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Temperature <36.0°C	33 participants	12 participants	384 participants	429 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Systolic blood pressure <90 mmHg	3 participants	3 participants	58 participants	64 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Systolic blood pressure >140 mmHg	26 participants	15 participants	310 participants	351 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Systolic blood pressure >160 mmHg	7 participants	0 participants	44 participants	51 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Diastolic blood pressure <50 mmHg	0 participants	2 participants	41 participants	43 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Diastolic blood pressure >90 mmHg	29 participants	12 participants	318 participants	359 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Pulse rate <60 bpm	35 participants	14 participants	446 participants	495 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Pulse rate >100 bpm	2 participants	1 participants	79 participants	82 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Body weight: Decrease of ≥7% from baseline	21 participants	12 participants	373 participants	406 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Respiratory rate <12 breaths/min	2 participants	2 participants	33 participants	37 participants
Vital Signs: Meeting Abnormal Criteria (Post-Baseline Measurement) Temperature >38.0°C	0 participants	1 participants	5 participants	6 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day to up to 215 weeks after first dose.

Exposure to Study Dose was measured in Safety Population. Modal daily dose defined as the dose taken the most days during the reporting phase or study; in case of ties, modal dose was defined as the highest dose level between the two doses in the tie.

Outcome measures

Outcome measures
Measure	YKP3089 and Phenytoin n=83 Participants Subjects taking phenytoin and cenobamate.	YKP3089 and Phenobarbital n=37 Participants Subjects taking phenobarbital and cenobamate.	YKP3089 and Other AEDs n=1220 Participants Subjects taking AEDs other than phenobarbital and phenytoin and taking cenobamate.	Safety Population n=1340 Participants All subjects enrolled in the study who received at least 1 dose of study drug medication were considered safety evaluable subjects.
Exposure to Study Dose - Length (Weeks) Length of Exposure (Weeks) - Overall	123.96 weeks/months/mg Standard Deviation 62.885	119.48 weeks/months/mg Standard Deviation 81.612	129.28 weeks/months/mg Standard Deviation 65.436	128.68 weeks/months/mg Standard Deviation 65.753
Exposure to Study Dose - Length (Weeks) Length of Exposure (Weeks) - Maintenance Phase	122.4 weeks/months/mg Standard Deviation 21.89	136.7 weeks/months/mg Standard Deviation 61.93	131.6 weeks/months/mg Standard Deviation 50.33	131.2 weeks/months/mg Standard Deviation 50.75

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 85 and Day 99 after first dose.

At Visit 8 and Visit 9, 2 blood samples were collected for the determination of YKP3089 plasma levels (YKP3089 and concomitant AED doses must have been stable for 2 weeks prior to these visits), at arrival and 30 minutes to 4 hours after the most recent dose. Plasma levels of phenytoin and phenobarbital were stable during the titration. The endpoint values are based on pharmacokinetic (PK) population.

Outcome measures

Outcome measures
Measure	YKP3089 and Phenytoin n=83 Participants Subjects taking phenytoin and cenobamate.	YKP3089 and Phenobarbital n=37 Participants Subjects taking phenobarbital and cenobamate.	YKP3089 and Other AEDs n=364 Participants Subjects taking AEDs other than phenobarbital and phenytoin and taking cenobamate.	Safety Population All subjects enrolled in the study who received at least 1 dose of study drug medication were considered safety evaluable subjects.
YKP3089 Plasma Levels (mcg/mL) Visit 8 (Day 85) / Arrival at clinic	12.5051 mcg/mL Standard Deviation 5.80730	12.4071 mcg/mL Standard Deviation 4.71288	14.6904 mcg/mL Standard Deviation 5.99973	—
YKP3089 Plasma Levels (mcg/mL) Visit 8 (Day 85) / Post-Dose	13.7470 mcg/mL Standard Deviation 6.02498	14.6900 mcg/mL Standard Deviation 4.44020	15.8694 mcg/mL Standard Deviation 5.92152	—
YKP3089 Plasma Levels (mcg/mL) Visit 9 (Day 99) / Arrival at clinic	11.8173 mcg/mL Standard Deviation 5.36440	13.2607 mcg/mL Standard Deviation 5.46875	15.4764 mcg/mL Standard Deviation 5.94161	—
YKP3089 Plasma Levels (mcg/mL) Visit 9 (Day 99) / Post-Dose	13.4618 mcg/mL Standard Deviation 5.69905	15.0770 mcg/mL Standard Deviation 5.25885	16.4892 mcg/mL Standard Deviation 5.87959	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day to up to 215 weeks after first dose.

Outcome measures

Outcome measures
Measure	YKP3089 and Phenytoin n=83 Participants Subjects taking phenytoin and cenobamate.	YKP3089 and Phenobarbital n=37 Participants Subjects taking phenobarbital and cenobamate.	YKP3089 and Other AEDs n=1220 Participants Subjects taking AEDs other than phenobarbital and phenytoin and taking cenobamate.	Safety Population n=1340 Participants All subjects enrolled in the study who received at least 1 dose of study drug medication were considered safety evaluable subjects.
Exposure to Study Dose - Length (Months) Length of Exposure (Months) - Overall	28.543 months Standard Deviation 14.4801	27.512 months Standard Deviation 18.7922	29.768 months Standard Deviation 15.0675	29.630 months Standard Deviation 15.1404
Exposure to Study Dose - Length (Months) Length of Exposure (Months) - Maintenance Phase	28.18 months Standard Deviation 11.949	31.47 months Standard Deviation 14.261	30.31 months Standard Deviation 11.589	30.20 months Standard Deviation 11.686

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day to up to 215 weeks after first dose.

Outcome measures

Outcome measures
Measure	YKP3089 and Phenytoin n=83 Participants Subjects taking phenytoin and cenobamate.	YKP3089 and Phenobarbital n=37 Participants Subjects taking phenobarbital and cenobamate.	YKP3089 and Other AEDs n=1220 Participants Subjects taking AEDs other than phenobarbital and phenytoin and taking cenobamate.	Safety Population n=1340 Participants All subjects enrolled in the study who received at least 1 dose of study drug medication were considered safety evaluable subjects.
Average Exposure to Study Dose Modal Daily Dose (mg) - Overall	223.34 mg Standard Deviation 100.528	183.11 mg Standard Deviation 105.500	219.32 mg Standard Deviation 107.154	218.57 mg Standard Deviation 106.808
Average Exposure to Study Dose Modal Daily Dose (mg) - Maintenance Phase	244.7 mg Standard Deviation 82.84	222.4 mg Standard Deviation 85.13	244.5 mg Standard Deviation 88.32	244.0 mg Standard Deviation 87.91

Adverse Events

YKP3089 and Phenytoin

Serious events: 15 serious events

Other events: 76 other events

Deaths: 2 deaths

YKP3089 and Phenobarbital

Serious events: 6 serious events

Other events: 35 other events

Deaths: 0 deaths

YKP3089 and Other AEDs

Serious events: 217 serious events

Other events: 1104 other events

Deaths: 8 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	YKP3089 and Phenytoin n=83 participants at risk Subjects taking phenytoin and cenobamate.	YKP3089 and Phenobarbital n=37 participants at risk Subjects taking phenobarbital and cenobamate.	YKP3089 and Other AEDs n=1220 participants at risk Subjects taking AEDs other than phenobarbital and phenytoin and taking cenobamate.
Eye disorders Diplopia	7.2% 6/83 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	5.4% 2/37 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	6.8% 83/1220 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.
Eye disorders Vision blurred	4.8% 4/83 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	8.1% 3/37 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	3.9% 48/1220 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.
Gastrointestinal disorders Nausea	6.0% 5/83 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	2.7% 1/37 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	4.4% 54/1220 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.
General disorders Fatigue	21.7% 18/83 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	21.6% 8/37 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	17.3% 211/1220 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.
General disorders Gait disturbance	7.2% 6/83 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	8.1% 3/37 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	4.3% 52/1220 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.
Metabolism and nutrition disorders Decreased appetite	6.0% 5/83 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	5.4% 2/37 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	1.9% 23/1220 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.
Nervous system disorders Ataxia	6.0% 5/83 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	10.8% 4/37 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	4.0% 49/1220 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.
Nervous system disorders Balance disorder	12.0% 10/83 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	8.1% 3/37 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	5.7% 69/1220 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.
Nervous system disorders Dysarthria	1.2% 1/83 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	8.1% 3/37 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	2.6% 32/1220 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.
Nervous system disorders Headache	4.8% 4/83 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	8.1% 3/37 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	9.4% 115/1220 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.
Nervous system disorders Nystagmus	8.4% 7/83 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	2.7% 1/37 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	2.1% 26/1220 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.
Nervous system disorders Somnolence	22.9% 19/83 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	40.5% 15/37 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.	29.4% 359/1220 • Adverse event data is collected from the initiation of any study procedures (Visit 1) to the end of treatment follow-up. The time frame of each participant varies from 1 day to up to 215 weeks on study treatment. The AE reporting period is defined as 30 days following the last administration of study treatment for serious adverse events (SAEs) and 14 days following the last administration of study treatment for all other AEs.

Additional Information

Medical Director

SK Life Science, Inc.

Phone: 402-835-5977

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place