Liquid vs. pill: new study tests easier way to take seizure drug
NCT ID NCT07176832
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested two versions of the seizure medication stiripentol (Diacomit®) in 24 healthy adults: a capsule and a liquid suspension. The goal was to see if the liquid form is absorbed by the body in a similar way to the capsule. If so, it could provide a more convenient option for children and adults with Dravet syndrome who have difficulty swallowing pills. The study also checked for side effects and how the liquid tastes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stiripentol (Diacomit®)
- What this could lead to
- If the oral suspension works as well as the capsule, it could offer a more convenient liquid option for people with Dravet syndrome who have trouble swallowing pills.
- What could go wrong
- This is a small, early-stage study in healthy volunteers, not patients. It only looks at how the drug is absorbed, not whether it actually helps control seizures. The liquid form may not prove equally effective in real-world use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
24 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
-
Aug 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Aged between 18 and 50 years (inclusive). * Considered healthy after a comprehensive clinical assessment (medical history + complete physical exam). * Body Mass Index (BMI) between 18 and 30 kg/m² (inclusive) and body weight ≥ 50 kg at screening. * Normal blood pressure (BP) and heart rate (HR) after 10 minutes supine at screening : Systolic BP: 90-145 mmHg, Diastolic BP: 45-90 mmHg, HR: 40-90 bpm, Or values outside these ranges but judged not clinically significant (NCS) by the Investigator. * Normal ECG at screening (10-min resting 12-lead ECG): PR interval: 110-210 ms, QRS interval : \< 120 ms, QTcF interval: ≤ 450 ms, No evidence of sinus node dysfunction, Or values outside these ranges but judged NCS by the Investigator. * Laboratory parameters within normal ranges (hematology, biochemistry, urinalysis); slight deviations allowed if not clinically relevant per Investigator. * Women of non-childbearing potential, or women of childbearing potential using at least one acceptable contraceptive method throughout the study and 1 month after last treatment. * Female subjects of childbearing potential: negative pregnancy test (serum or urine) at screening and Day 0. * Covered by Health Insurance System and/or compliant with National Law requirements for biomedical research. * Able and willing to comply with study requirements. * Written informed consent obtained. Exclusion Criteria * Unsuitable veins for repeated venipuncture. * Relevant history/presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease. * Evidence of any clinically significant acute or chronic disease. * History of suicidal ideation or suicide attempt. * Surgery (including clinical trial procedures) within 2 months before dosing. * Blood donation within 2 months before dosing. * History/presence of drug hypersensitivity, asthma, or allergy. * Known hypersensitivity to study materials or related compounds. * Inability/difficulty swallowing capsules. * No possibility of emergency contact. * Any drug intake (except paracetamol) within 4 weeks prior to dosing or \< 5 half-lives (whichever longer). Prohibited: carbamazepine, phenytoin, phenobarbital, CYP enzyme modulators. * Use of herbal products affecting CYP enzymes within 2 weeks or \< 5 half-lives before dosing. * Special diets (vegetarian, vegan, gluten-free). * Vigorous exercise from 4 days before dosing until post-study assessments. * Pregnant or breastfeeding women. * Drug/alcohol abuse history, daily alcohol intake \> 4 drinks, or positive alcohol test. * Excessive xanthine beverages (\> 5 cups/day). * Nicotine use \> 5 cigarettes/day or inability to abstain 48h before and during study. * Intake of grapefruit/Seville oranges/poppy seed or other CYP modulators 1 week before dosing and during study. * Intake of methylxanthines (coffee, tea, cola, cocoa, mate, guarana, chocolate) or quinine (e.g., tonic water) from 48h before dosing and during study. * Unable/unwilling to follow diet requirements (see protocol section 10.7). * Positive test for HBsAg, HCV antibody, or HIV 1/2. * Positive drug screen. * Significant biological or clinical abnormalities judged incompatible with study. * Participation in another interventional trial during exclusion period or investigational product within last 60 days or \< 5 half-lives. * Under guardianship, curatorship, or deprived of liberty. * Under Court protection. * Would exceed €6000 compensation for biomedical research in last 12 months (including this study). * Health status not allowing provision of informed consent.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Childhood are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
3 Chemin d'Armancourt
Compiègne, 60200, France
-
EUROFINS OPTIMED, 1 rue des Essarts
Gières, 38610, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can lavender and lullabies help kids with epilepsy sleep better?
- Reading the Brain's signals to predict who benefits from deep brain stimulation
- Can a Comfort-Focused education program improve life with epilepsy?
- Can video games rewire young brains after injury?
- High-Fat Diet's effect on epilepsy: scientists track brain signals
- Can a Choose-Your-Own-Adventure comic help kids eat better and move more?