At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 31 enrolled
Drug / intervention
Diazepamdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Study to Determine the Pharmacokinetics of a Single Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode for Which Acute Treatment With a Benzodiazepine is Clinically Indicated
In Brief
A Phase 2 clinical trial evaluating Diazepam for Epilepsy. Completed, enrolled 31 participants across 4 sites.
Detailed Summary
The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray following a single dose in epileptic patients experiencing a seizure episode.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartSep 2011
Primary CompletionFeb 2013
Study CompletionMar 2013
TodayJul 2026
First PostedAug 16, 2011
Enrollment StartSep 1, 2011
Primary CompletionFeb 1, 2013
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.9 years ago
Interventions
Diazepamdrug
single-dose; dosage in mg, based on patient body weight