Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Clonazepam 2 mg | Experimental |
| |
| Intranasal Clonazepam 3 mg | Experimental |
| |
| Intranasal Clonazepam both Dose Groups 2 mg & 3 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonazepam | Drug | 1 Dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to treatment day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Beverly Benson, PhD | Jazz Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials. inc. | Little Rock | Arkansas | 72205 | United States | ||
| Mid-Atlantic Epilepsy & Sleep Center |
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Clonazepam 2 mg | Treatment administered to subjects during Cohort 1 |
| FG001 | Intranasal Clonazepam 3 mg | Treatment administered to subjects during Cohort 2 |
| FG002 | Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg | Subjects who were administered 2 mg during Cohort 1 and then 3 mg during Cohort 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 / Treatment Period 1 |
| |||||||||||||
| Cohort 2 / Treatment Period 2 |
|
There were 9 subjects total and 2 subjects were enrolled in both Cohorts.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intranasal Clonazepam 2 mg | |
| BG001 | Intranasal Clonazepam 3 mg | |
| BG002 | Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of baseline | Change from baseline to treatment day |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intranasal Clonazepam 2 mg |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lacrimation increased | Eye disorders | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director, Clinical Development | Jazz Pharmaceuticals, Inc. | 650 496 3777 |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002998 | Clonazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bethesda |
| Maryland |
| 20817 |
| United States |
| Columbia Comprehensive Epilepsy Center, Neurological Institute | New York | New York | 10032 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Neurological Clinic of Texas, PA | Dallas | Texas | 75232 | United States |
| Tampere University Hospital | Tampere | 33521 | Finland |
| NOT COMPLETED |
|
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | Intranasal Clonazepam 3 mg | 0 | 5 | 2 | 5 |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Tongue Ulceration | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Drooling | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Nasal Dryness | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hypoaesthesia Facial | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA | Non-systematic Assessment |
|
Not provided
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |