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 (NCT01390220) involved a treatment called USL261, a midazolam nasal spray, being studied in people experiencing prolonged or repeated seizures. The trial ran in two phases. In the first phase (the "test dose phase"), 292 participants received USL261 to check how they responded; 201 of them completed this phase. Those who responded well — 201 people — then moved into the second phase (the "comparative phase"), where 134 participants were randomly assigned to receive USL261 and 67 were assigned to receive a placebo (an inactive treatment with no medicine in it). The main thing being measured was whether participants met the criteria for "treatment success," defined as their seizure stopping within 10 minutes of receiving the study drug and not returning for at least 6 hours afterwards. The reported data shows that in the comparative phase, 72 out of 134 participants in the USL261 group met the criteria for treatment success, compared with 23 out of 67 participants in the placebo group. For the secondary outcomes — which looked at what happened after the 10-minute mark — the reported data shows that 51 out of 134 participants in the USL261 group had a seizure return between 10 minutes and 4 hours after the dose, compared with 40 out of 67 in the placebo group. When looking at seizure return over a longer 24-hour window, 50 participants in the USL261 group and 31 in the placebo group had another seizure during that period. For the time until the next seizure after 10 minutes, the reported data shows a figure of 12.1 hours for the placebo group; no corresponding figure was reported for the USL261 group. 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 36410152) ↗
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, Terminated
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:
- You have a responsible adult caregiver who can watch for and recognize your seizure episodes
- You have been diagnosed with epilepsy (either partial or generalized) with a confirmed pattern of seizure clusters
- Your seizure clusters last at least 10 minutes
- Your seizure cluster pattern is recognizable, follows a consistent pattern, and looks clearly different from any other seizures you may have
- A second seizure in your cluster typically happens within 6 hours of the cluster being recognized
- Your seizure clusters involve 2 or more seizures grouped together
- Your seizure cluster pattern has been established for more than 3 months before the first study visit
- You have had at least 3 seizure clusters in the year before the first study visit
- You have had at least 1 seizure cluster within the 4 months before the first study visit
- Your seizure cluster pattern has been reviewed and confirmed by a central medical reviewer
- You are currently on a steady, unchanged seizure medication routine, with no changes for at least 7 days before the second study visit
- Your weight is between 40 kg (about 88 lbs) and 125 kg (about 276 lbs)
Who may not be able to join:
- You have a neurological condition that is expected to get worse over the next year
- You have serious long-term heart or breathing problems
- You have had seizures that turned out not to be epileptic (sometimes called psychogenic or non-epileptic seizures) within the past 5 years
- Your seizure clusters have developed into a dangerous prolonged seizure state (called status epilepticus) within the past 2 years
- You have a history of a specific eye condition called acute narrow-angle glaucoma
- You have had thoughts of suicide or a suicide plan in the past 6 months, or have attempted suicide in the past 5 years
- You currently use a vagal nerve stimulator (VNS — a device implanted to help control seizures), unless it has been in place for at least 6 months and the settings have been unchanged for at least 4 weeks before the first study visit
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
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
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.