Epilepsy
Conditions
Brief summary
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
Interventions
DRUGClonazepam
1 Dose
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%). | Change from baseline to treatment day | Summary of video EEG number of spikes and sharp waves. Over a 24 hour period. |
Countries
Finland, United States
Participant flow
Pre-assignment details
Based on preliminary PK data, the study was terminated early prior to achieving planned enrollment numbers. Cohort 1 was dosed at 2mg. Cohort 2 was dosed at 3mg. Two subjects participated in both Cohorts.
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Clonazepam 2 mg | 4 |
| Intranasal Clonazepam 3 mg | 3 |
| Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg | 2 |
| Total | 9 |
Baseline characteristics
| Characteristic | Intranasal Clonazepam 3 mg | Total | Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg | Intranasal Clonazepam 2 mg |
|---|---|---|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 7.37 | 33.4 years STANDARD_DEVIATION 9.25 | 45.0 years STANDARD_DEVIATION 1.41 | 30.5 years STANDARD_DEVIATION 8.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 9 Participants | 2 Participants | 4 Participants |
| Region of Enrollment Finland | 2 participants | 5 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 1 participants | 4 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 6 | 2 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
Primary
Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).
Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.
Time frame: Change from baseline to treatment day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Clonazepam 2 mg | Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%). | -7.4 percentage of baseline | Standard Deviation 35.12 |
| Intranasal Clonazepam 3 mg | Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%). | -26.1 percentage of baseline | Standard Deviation 33.94 |