Staccato alprazolam for Epilepsy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
EpilepsyStaccato alprazolam - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests if Staccato Alprazolam is more successful than placebo in terminating a seizure within 90 seconds and preventing recurrence for 2 hours.

Eligible Conditions
  • Epilepsy

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: From start of IMP treatment up to the Safety Follow-up Visit (Week 19)

Hour 2
Number of subsequent seizure(s) up to 2 hours after IMP administration
Time to first subsequent seizure up to 2 hours after IMP administration
Treatment success for the treated seizure with no recurrence after 2 hours
Treatment success for the treated seizure with no recurrence up to 2 hours
Hour 4
Treatment success for treated seizure with no recurrence after 4 hours
Hour 6
Time from IMP administration to cessation of the treated seizure
Treatment success for the treated seizure within 90 seconds after investigational medicinal product (IMP) administration
Treatment success for treated seizure with no recurrence after 6 hours
Week 19
Frequency of respiratory treatment emergent adverse events (TEAEs)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Staccato alprazolam Arm
1 of 2
Placebo Arm
1 of 2

Experimental Treatment

Non-Treatment Group

250 Total Participants · 2 Treatment Groups

Primary Treatment: Staccato alprazolam · Has Placebo Group · Phase 3

Staccato alprazolam Arm
Drug
Experimental Group · 1 Intervention: Staccato alprazolam · Intervention Types: Drug
Placebo Arm
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from start of imp treatment up to the safety follow-up visit (week 19)

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
85 Previous Clinical Trials
20,524 Total Patients Enrolled
12 Trials studying Epilepsy
2,133 Patients Enrolled for Epilepsy
UCB CaresStudy Director001 844 599 2273 (UCB)
189 Previous Clinical Trials
43,410 Total Patients Enrolled
47 Trials studying Epilepsy
11,551 Patients Enrolled for Epilepsy

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a minimum of 5 generalized seizure episodes with a minimum total duration of 5 minutes.
You have had at least 3 focal seizures in the past year.
You have had at least one focal seizure or a flurry of myoclonic seizures for at least 90 seconds followed by a generalized/bilateral tonic-clonic seizure with a minimum total duration of 3 minutes.
You have experienced ≥4 stereotypical episodes of prolonged seizures in the past 6 months, and the last 2 stereotypical episodes of prolonged seizures must have occurred within the 3 months prior to the Screening Visit.
You are a male participant and you must agree to use contraception during the Outpatient Treatment Period and for at least 7 days after IMP administration and refrain from donating sperm during this period.
You are a WOCBP and you agree to follow the contraceptive guidance during the Outpatient Treatment Period and for at least 30 days after IMP administration.
You have a documented brain computerized tomography or magnetic resonance imaging review, performed after diagnosis of epilepsy and within the 5 years prior to the Screening Visit, that confirms the absence of a progressive neurological disorder.