Phase 2
N=6
Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00594945 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%). — -7.4; -26.1 percentage of baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Clonazepam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%). |
-7.4; -26.1 | — |
Summary
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of refractory epilepsy
- No Nasal conditions that would preclude the use of intranasal product
Exclusion Criteria
- Subject with a clinical significant unstable medical abnormality
- Subject currently or regularly taking Clonazepam
Data sourced from ClinicalTrials.gov (NCT00594945). 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.