Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 BID orally or matching placebo BID in each of two treatment periods. Two doses of NPT 2042 will be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPT 2042 80mg | Active Comparator | NPT 2042 80mg BID |
|
| Placebo for NPT 2042 80mg | Placebo Comparator | Matching placebo for active comparator |
|
| NPT 2042 160mg | Active Comparator | NPT 2042 160mg BID |
|
| Placebo for NPT 2042 160mg | Placebo Comparator | Matching placebo for active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPT 2042 | Drug | NPT 2042 is a new drug being developed as an anti-seizure treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean 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. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject has metabolic or mitochondrial encephalopathies, seizures associated with structural abnormalities, or infection-related seizures.
Subject has a developmental epileptic encephalopathy (e.g. Lennox-Gastaut syndrome)
Subject has a history of convulsive status epilepticus within the past year.
Subject has a history of surgical intervention for treatment of epilepsy
Subject has a history of nonepileptic seizures (e.g., metabolic, structural, or paroxysmal non epileptic seizures)
Subject has severe intellectual disability, severe autism spectrum disorder, or severe developmental disorder such that the subject cannot consent or assent to participate or cannot cooperate with the study procedures
Female subject who is pregnant or lactating
Subject has any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the subject from the study
Subject has an active CNS infection, demyelinating disease, degenerative neurological disease, or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
Subject has any clinically significant psychiatric illness, psychological or behavioral problems which, in the opinion of the investigator, would interfere with the subject's ability to participate in the study, including but not limited to the following:
Subject is suffering from clinically significant active liver disease, porphyria or has a family history of severe hepatic dysfunction indicated by abnormal liver function tests greater than three times the upper limit of normal (AST and ALT)
Subject has a DSM-V diagnosis of alcohol or drug abuse, or drug addiction within the past 12 months
Subject has participated in any other trials involving an investigational product or device within 30 days of screening or longer, as required by local regulations
Subject is currently using prohibited medications or products
Subject is unable to complete ingestion of four placebo SGCs with a minimum of eight ounces of water at screening
Subject (and parent/caregiver, if applicable) has daily commitments during the study duration that would interfere with attending all study visits
Positive urine drug test for substance of abuse or illegal recreational substances at screening
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JoAnn Giannone | Contact | 9196371566 | joann@npt.io | |
| Charles Moser | Contact | chuckmoser.nlc@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials, Inc. (CTI) | Recruiting | Little Rock | Arkansas | 77205 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Placebo Comparator |
|
| 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:
|
| 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:
| 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) | 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 | 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 | Up to 12 weeks |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D004832 | Epilepsy, Absence |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
Not provided
Not provided