Phase 2
Completed N=31
A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode
Source: ClinicalTrials.gov NCT01417078 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax), — 208; 23.9 nanogram/milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax), |
208; 23.9 | — |
| PRIMARY Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) |
0.98; 11.10 | — |
| PRIMARY Pharmacokinetic (PK) Parameter: Area Under The Concentration Curve From Time 0 to 12 Hours (AUC(0-12)) and AUC Time to Last Measurable Plasma Concentration |
1227; NA; NA; 192 | — |
| SECONDARY Number of Patients With Treatment Emergent Adverse Events (TEAEs) |
28; 96; 21; 56; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Provide signed informed consent for study participation.
- General good health with no clinically significant unstable abnormalities.
- Diagnosis of epilepsy.
Exclusion Criteria
- Individuals receiving warfarin (Coumadin®) or dabigatran (Pradaxa®).
- Use of any investigational drug within 30 days.
- Blood or plasma donation within 30 days.
- Not willing or unable to tolerate blood draws.
Data sourced from ClinicalTrials.gov (NCT01417078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.