Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 262 participants across two separate studies (Study 1 and Study 3). The trial was measuring how a drug called ZX008 (given at two different daily doses — a lower dose of 0.2 mg/kg/day and a higher dose of 0.8 mg/kg/day) compared to a placebo (a dummy treatment with no active ingredient) in changing how often participants experienced convulsive seizures — that is, seizures involving physical movements such as jerking, stiffening, or falling. Seizure counts were tracked over 28-day periods using electronic diaries. The reported data shows that, for the main (primary) outcome — change in average monthly convulsive seizure count — participants in Study 1 who received the higher dose of ZX008 had a reported change of minus 13.11 seizures per 28 days from their starting point, compared to minus 6.71 for the placebo group. In Study 3, the higher dose group showed a change of minus 3.54 seizures per 28 days, while the placebo group showed a change of plus 1.54 (meaning that group's average count went slightly up). For the lower dose, Study 1 reported a change of minus 18.81 seizures per 28 days versus minus 6.71 for placebo, and Study 3 reported minus 5.89 versus plus 1.54. The reported data also shows the proportions of participants who saw large reductions in seizure frequency: for example, in Study 1, 67.5% of those on the higher dose and 38.5% on the lower dose were reported to have had at least a 50% reduction in seizures, compared to 12.5% in the placebo group. In Study 3, those figures were 72.9% and 45.7%, compared to 6.3% for placebo. Complete seizure freedom (100% reduction) was reported in 7.5% of the Study 1 higher-dose group and 12.5% of the Study 3 higher-dose group, with 0% in both placebo groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 37543865) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Epilepsy Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Children and teenagers between 2 and 18 years old (male or female, but not pregnant or breastfeeding females)
- Has been diagnosed with Dravet syndrome, where seizures are not fully controlled by current seizure medications
- Has had a minimum number of convulsive (shaking/jerking) seizures over the past 12 weeks (the trial site can tell you the exact number required)
- Has been on a stable seizure treatment plan for at least 4 weeks before the start of the study, with no changes expected during the study
- Has no problems with the heart or lungs, based on recent tests and a physical exam
- The parent or caregiver is able and willing to keep a daily diary, attend scheduled visits, and manage the study medication responsibly
Who may not be able to join:
- Has a condition causing high blood pressure in the lungs (confirm with trial site)
- Has a current or past history of heart or blood vessel problems, such as heart valve disease, heart attack, or stroke
- Has a current or past history of glaucoma (increased pressure in the eye)
- Has moderate or severe liver problems
- Is currently taking certain medications, including appetite suppressants, MAO inhibitors, serotonin-related medications (such as antidepressants known as SSRIs), atomoxetine, or cyproheptadine (confirm with trial site)
- Has taken a medication called stiripentol in the 21 days before the study screening visit
- Is currently taking, or has taken in the past 30 days, any of these medications: carbamazepine, oxcarbazepine, eslicarbazepine, phenobarbital, or phenytoin
- Tests positive for cannabis-related substances (THC or CBD) at the screening visit
- Has any other significant health condition that could interfere with taking part in the study or could put them at risk
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: UCB Cares, 001 844 599 2273
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline in the Mean Convulsive Seizures Frequency (MCSF) to the Combined Titration and Maintenance Periods (T+M) in Participants Receiving ZX008 0.8 mg/kg/Day Compared to Placebo
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.