Trial Outcomes & Findings for Effects of Perampanel on Neurophysiology Test Perimeters (NCT NCT03653741)

NCT ID: NCT03653741

Last Updated: 2023-07-03

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

pre-dose and post-dose of drug intake, 7 hours

Results posted on

2023-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Males healthy males will undergo EEG, VEP, BAER, and SEP testing, then take a single dose of Perampanel 6 MG pill (intervention), then have blood drawn and undergo the 4 tests mentioned previously for a second time Perampanel 6 MG: Perampanel is a drug approved and marketed in the USA for the treatment of epilepsy to prevent recurrent seizures. In a previous study, healthy volunteers have tolerated a single dose of perampanel at 6 mg quite well.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Males n=12 Participants healthy males will undergo EEG, VEP, BAER, and SEP testing, then take a single dose of Perampanel 6 MG pill (intervention), then have blood drawn and undergo the 4 tests mentioned previously for a second time Perampanel 6 MG: Perampanel is a drug approved and marketed in the USA for the treatment of epilepsy to prevent recurrent seizures. In a previous study, healthy volunteers have tolerated a single dose of perampanel at 6 mg quite well.
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants
Sex: Female, Male Female	0 Participants n=12 Participants
Sex: Female, Male Male	12 Participants n=12 Participants
Region of Enrollment United States	12 participants n=12 Participants

PRIMARY outcome

Timeframe: pre-dose and post-dose of drug intake, 7 hours

Population: Data wasn't collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: pre-dose and post-dose of drug intake, 7 hours

Outcome measures

Outcome measures
Measure	Healthy Males n=12 Participants healthy males will undergo EEG, VEP, BAER, and SEP testing, then take a single dose of Perampanel 6 MG pill (intervention), then have blood drawn and undergo the 4 tests mentioned previously for a second time Perampanel 6 MG: Perampanel is a drug approved and marketed in the USA for the treatment of epilepsy to prevent recurrent seizures. In a previous study, healthy volunteers have tolerated a single dose of perampanel at 6 mg quite well.
Change in Baseline Visual Evoked Potential (P100) Latency	1.81 ms Interval -2.325 to 3.125

PRIMARY outcome

Timeframe: pre-dose and post-dose of drug intake, 7 hours

Population: data was not collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: pre-dose and post-dose of drug intake, 7 hours

Outcome measures

Outcome measures
Measure	Healthy Males n=12 Participants healthy males will undergo EEG, VEP, BAER, and SEP testing, then take a single dose of Perampanel 6 MG pill (intervention), then have blood drawn and undergo the 4 tests mentioned previously for a second time Perampanel 6 MG: Perampanel is a drug approved and marketed in the USA for the treatment of epilepsy to prevent recurrent seizures. In a previous study, healthy volunteers have tolerated a single dose of perampanel at 6 mg quite well.
Change in Baseline Brainstem Auditory Evoked Potential (Waves I, III, V) Latency	0.02 ms Interval -0.175 to 0.25

PRIMARY outcome

Timeframe: pre-dose and post-dose of drug intake, 7 hours

Population: data was not collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: pre-dose and post-dose of drug intake, 7 hours

Outcome measures

Outcome measures
Measure	Healthy Males n=12 Participants healthy males will undergo EEG, VEP, BAER, and SEP testing, then take a single dose of Perampanel 6 MG pill (intervention), then have blood drawn and undergo the 4 tests mentioned previously for a second time Perampanel 6 MG: Perampanel is a drug approved and marketed in the USA for the treatment of epilepsy to prevent recurrent seizures. In a previous study, healthy volunteers have tolerated a single dose of perampanel at 6 mg quite well.
Change in Baseline Somatosensory Evoked Potential (N20) Latency	-0.256 ms Interval -0.325 to 0.175

PRIMARY outcome

Timeframe: pre-dose and post-dose of drug intake, 7 hours

Outcome measures

Outcome measures
Measure	Healthy Males n=12 Participants healthy males will undergo EEG, VEP, BAER, and SEP testing, then take a single dose of Perampanel 6 MG pill (intervention), then have blood drawn and undergo the 4 tests mentioned previously for a second time Perampanel 6 MG: Perampanel is a drug approved and marketed in the USA for the treatment of epilepsy to prevent recurrent seizures. In a previous study, healthy volunteers have tolerated a single dose of perampanel at 6 mg quite well.
Change in Baseline Electroencephalography Background Frequency Content	-0.25 Hz Interval -2.0 to 1.0

Adverse Events

Healthy Males

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Healthy Males n=12 participants at risk healthy males will undergo EEG, VEP, BAER, and SEP testing, then take a single dose of Perampanel 6 MG pill (intervention), then have blood drawn and undergo the 4 tests mentioned previously for a second time Perampanel 6 MG: Perampanel is a drug approved and marketed in the USA for the treatment of epilepsy to prevent recurrent seizures. In a previous study, healthy volunteers have tolerated a single dose of perampanel at 6 mg quite well.
General disorders drowsiness	25.0% 3/12 • 7h Subjects were asked to report any adverse events during the study visit.
Nervous system disorders headache	25.0% 3/12 • 7h Subjects were asked to report any adverse events during the study visit.
Nervous system disorders vertigo	33.3% 4/12 • 7h Subjects were asked to report any adverse events during the study visit.
General disorders fatigue	8.3% 1/12 • 7h Subjects were asked to report any adverse events during the study visit.
General disorders nausea	16.7% 2/12 • 7h Subjects were asked to report any adverse events during the study visit.
General disorders dizziness	25.0% 3/12 • 7h Subjects were asked to report any adverse events during the study visit.
Eye disorders nystagmus	8.3% 1/12 • 7h Subjects were asked to report any adverse events during the study visit.

Additional Information

David Chuang, MD

Weill Cornell Medical College

Phone: 212-746-5519

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place