This study will compare the effect of NPT 2042 and placebo in subjects with GGE on the frequency and duration of electroencephalographic absence seizures, separated by a 14-day washout period. The study will be a single-center, double-blind, crossover study with subjects receiving either NPT 2042 80 mg BID orally or matching placebo BID in each of two treatment periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
NPT 2042 is a new drug being developed as an anti-seizure treatment
Placebo Comparator
Clinical Trials, Inc. (CTI)
Little Rock, Arkansas, United States
RECRUITINGMean and median across subjects of the within subject difference in percent change from treatment period baseline of the frequency of absence seizures
Mean and median across subjects of the within subject difference in percent change from treatment period baseline of the frequency of absence seizures (defined as 2.5-6 Hz spike-wave bursts lasting greater than 3 seconds) between NPT 2042 and placebo.
Time frame: Up to 12 weeks
Mean and median across subjects of the within subject difference between NPT 2042 and placebo on absence seizures
Mean and median across subjects of the within subject difference between NPT 2042 and placebo on absence seizures (defined as 2.5-6 Hz spike-wave bursts lasting greater than 3 seconds) average duration.
Time frame: Up to 12 weeks
Mean and median across subjects of the within subject categorical difference in percent change between NPT 2042 and placebo of the frequency of absence seizure
Mean and median across subjects of the within subject categorical difference in percent change between NPT 2042 and placebo of the frequency of absence seizure (defined as 2.5-6 Hz spike wave bursts lasting greater than 3 seconds) using the following categories: * \<10 seconds * 10-20 seconds * \>20 seconds
Time frame: Up to 12 weeks
The proportion of NPT 2042- vs. placebo-treated subjects meeting the study specific response criteria
The proportion of NPT 2042- vs. placebo-treated subjects meeting the following response criteria: * ≥50% decrease in endpoint seizure frequency compared to treatment period baseline * ≥75% decrease in endpoint seizure frequency compared to treatment period baseline * Seizure freedom
Time frame: Up to 12 weeks
The mean change from Baseline across subjects of the within subject difference between NPT 2042 and placebo on the Quality of Life in Epilepsy Questionnaire (QOLIE-31-P)
The mean change from Baseline across subjects of the within subject difference between NPT 2042 and placebo on the Quality of Life in Epilepsy Questionnaire (QOLIE-31-P)
Time frame: Up to 12 weeks
The mean change from Baseline in the Digit Symbol Substitution Test
The mean change from Baseline in the Digit Symbol Substitution Test following treatment with NPT 2042 compared to placebo
Time frame: Up to 12 weeks
The mean change from Baseline in the Epworth Sleepiness Scale
The mean change from Baseline in the Epworth Sleepiness Scale following treatment with NPT 2042 compared to placebo
Time frame: Up to 12 weeks
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