Trials / Terminated
TerminatedNCT02474407
Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
An Open-Label, Randomized, Crossover Pharmacokinetic Study to Determine the Bioavailability, Safety and Tolerability of Single Doses of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®) in Patients With Refractory Epilepsy
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- Acorda Therapeutics · Industry
- Sex
- All
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy. Cohort 1 comprises the subjects used to determine the relative bioavailability of DZNS versus DRG (Diastat)
Detailed description
To determine the bioavailability of diazepam nasal spray versus diazepam rectal gel (Diastat®) under conditions of use in adolescent and adult persons with epilepsy (PWE) meeting the definition of refractory epilepsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | diazepam nasal spray | |
| DRUG | diazepam rectal gel |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2016-05-01
- Completion
- 2016-07-01
- First posted
- 2015-06-17
- Last updated
- 2018-10-16
- Results posted
- 2018-10-16
Locations
22 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02474407. Inclusion in this directory is not an endorsement.