Actively Recruiting
A Single-center, Double-blind, Placebo-controlled Crossover Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures
Led by NeuroPro Therapeutics, Inc. · Updated on 2026-05-29
12
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of NPT 2042, a new anti-seizure drug, compared with placebo in people aged 16 to 75 years who have genetic generalized epilepsy (GGE) with absence seizures. This study aims to measure how these treatments affect the frequency and duration of absence seizures using electroencephalogram (EEG) recordings. The trial is a Phase 2, single-center, double-blind, placebo-controlled crossover study sponsored by NeuroPro Therapeutics, Inc. Participants will receive either NPT 2042 or a matching placebo twice daily during two treatment periods separated by a 14-day washout. Two different doses of NPT 2042 (80mg and 160mg twice daily) will be tested. Each participant will receive both the active drug and placebo at different times in a randomized order to compare the effects directly. During the study, participants will undergo EEG monitoring for seizure activity and complete assessments like the Quality of Life in Epilepsy Questionnaire, Digit Symbol Substitution Test, and Epworth Sleepiness Scale. Researchers will track changes in seizure frequency and duration over up to 12 weeks, monitor safety, and evaluate overall quality of life and cognitive function. The total study duration includes treatment and follow-up periods to assess outcomes.
CONDITIONS
Brief Title
A Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is capable of and provides consent/assent, with signed informed consent from parent/legal representative/caregiver for minors
- Aged 16 to 75 years at time of consent/assent
- Diagnosed with genetic generalized epilepsy with absence seizures per ILAE 2017 classification
- EEG showing bilateral synchronous generalized paroxysmal spike-wave bursts (2.5-6 Hz) lasting 3 seconds or more at least 4 times on 72-hour ambulatory EEG
- On stable dose of at least one antiseizure medication or stable vagal nerve stimulation settings for at least 30 days before screening
- Normal cognition and no significant neurological abnormalities at screening
- Otherwise in good health aside from epilepsy
- Body mass index between 18 and 40 kg/m2 inclusive
- Females of child-bearing potential and males agree to use effective contraception during study and for 28 days after last dose
- Able to communicate and comply with study requirements and visit schedule
You will not qualify if you...
- Metabolic or mitochondrial encephalopathies, seizures from structural abnormalities or infections
- Developmental epileptic encephalopathies such as Lennox-Gastaut syndrome
- History of convulsive status epilepticus within the past year
- History of epilepsy surgery
- History of nonepileptic seizures
- Severe intellectual disability, severe autism spectrum disorder, or severe developmental disorder preventing consent or cooperation
- Pregnant or lactating females
- Clinically significant laboratory abnormalities excluding participation
- Active CNS infection, demyelinating disease, degenerative neurological disease, or progressive CNS disease
- Significant psychiatric illness or behavioral problems interfering with participation, including active suicidal ideation or history of suicide attempt
- Clinically significant active liver disease or family history of severe hepatic dysfunction
- Diagnosis of alcohol or drug abuse/addiction within past 12 months
- Participation in other investigational trials within 30 days before screening
- Use of prohibited medications or products
- Inability to ingest four placebo soft gel capsules with water at screening
- Daily commitments interfering with attending all study visits
- Positive urine drug test for substances of abuse or illegal recreational drugs at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments including EEG
Duration - Up to 12 weeks per treatment period
Participants receive NPT 2042 or placebo in a crossover design to evaluate effects on absence seizures.
Multiple visits during treatment periods as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Clinical Trials, Inc. (CTI)
Little Rock, Arkansas, United States, 77205
Actively Recruiting
Research Team
J
JoAnn Giannone
C
Charles Moser
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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