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Pregabalin open label flexible dose Drug: Pregabalin Pregabalin administered as either capsule or liquid oral formulations. Children less than 17 years of age will receive from 2. Treatment emergent are events between first svegi of study drug and up to 28 days after last dose of study drug up to 13 months that were absent before treatment or that worsened relative to pretreatment state.
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Treatment emergent are events between first dose of study drug and up to 28 days after last dose of study drug up to 13 months that were absent before treatment or that worsened relative to pretreatment state. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spre to both sides of the brain as a tonic-clonic seizure and usually cyat 1 to 3 minutes.
Investigator judged clinically ificant change from baseline in physical and neurological examination findings. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Relatedness to study drug was assessed by the investigator.
To learn more romo this study, you or your doctor may contact the study research staff using the contacts provided below. Children less than 17 years of age will receive from 2.
A participant's RCI was calculated by dividing the change from individual baseline score by [square root 2] times WSDwhere WSD is within-subject standard deviation from Cogstate detection task normative data. An event a card turning face up occurred in center of computer screen and participant decided if event met a predefined rlom unchanging criterion is the color of the card black?
Participants were evaluated for pubic hair distribution, breast development only females and genital development only maleswith values ranging from stage 1 pre-pubertal characteristics to stage 5 adult or mature characteristics.
AEs included both serious and non-serious AEs. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient of practice trials.
Participant pressed a "YES" response key as soon as they detected an event ie, a card turning face up presented in the center of the computer screen. Participants had to "respond as fast and as accurately as possible.
For general information, Learn About Clinical Studies. C-SSRS responses mapping to C-CASA suicidal behavior codes 1, 2, or 3 are as follows: 1 completed suicide; 2 suicide acult response of "Yes" on "actual attempt" ; 3 preparatory acts toward imminent suicidal behavior "Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior".
Talk with your doctor and family members or friends about deciding to a study.
This kind of seizure is brief, lasting seconds to less than 2 minutes. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. For each task, participant responded "yes" using a response button with dominant hand.
C-SSRS responses mapping to C-CASA suicidal ideation code 4 are as follows: "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with any methods not plan without intent to act", "active suicidal ideation with some intent to act, without specific plan", "active suicidal ideation with some intent to act, without specific plan". Partial onset seizure: a seizure that starts in one area of the brain. Pregabalin open label flexible dose Drug: Pregabalin Pregabalin administered as either capsule or liquid oral formulations.
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