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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diazepam Nasal Spray | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazepam | Drug | single-dose; dosage in mg, based on patient body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax), | Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Cmax. The mean Cmax value was adjusted to a 20 mg dose. | Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours |
| Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) | Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Tmax. The mean Tmax value was adjusted to a 20 mg dose. | Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours |
| 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 | Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter AUC(0-12) and AUC(last). The mean estimate of AUC(0-12) was adjusted to a 20 mg dose. AUC(last) was used for the calculation of AUC for nordiazepam. AUC(0-12) values could not be estimated for nordiazepam given that nordiazepam concentrations were rising between 6 and 12 hours. | Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment Emergent Adverse Events (TEAEs) | TEAEs refer to adverse events with start dates occurring after dosing. Treatment-Related TEAEs refer to those 'possibly' or 'probably' related to study drug. Intensity definitions:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David P Ward, MD | Neuronex, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurology Clinics at St Joseph's Hospital | Phoenix | Arizona | 85013 | United States | ||
| Johns Hopkins University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diazepam Nasal Spray | Diazepam: single-dose; dosage in mg, based on patient body weight |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population Number (N)=31 Pharmacokinetic Population N=30
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| ID | Title | Description |
|---|---|---|
| BG000 | Diazepam Nasal Spray | Diazepam: single-dose; dosage in mg, based on patient body weight |
| 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 | Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax), | Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Cmax. The mean Cmax value was adjusted to a 20 mg dose. | PK Population: patients who had adequate concentration-time data to permit estimation of noncompartmental PK parameters. One patient was not included in the analysis of nordiazepam due to receiving clorazepate, which interfered with the analysis of nordiazepam from diazepam administration. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours |
|
Pre-dose to 48 hours post-dose
TEAEs refer to AEs with start date and times occuring after dosing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diazepam Nasal Spray | Diazepam: single-dose; dosage in mg, based on patient body weight |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (14.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director - Clinical Development & Medical Affairs | Acorda Therapeutics, Inc. | 914-347-4300 | 5367 | dsquillacote@acorda.com |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003975 | Diazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Pre-dose to 48 hours post-dose |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | (kg/m^2) |
|
Diazepam was slowly converted to nordiazepam following intranasal administration |
|
|
| Secondary | Number of Patients With Treatment Emergent Adverse Events (TEAEs) | TEAEs refer to adverse events with start dates occurring after dosing. Treatment-Related TEAEs refer to those 'possibly' or 'probably' related to study drug. Intensity definitions:
| Safety Population (dosed with study drug) | Posted | Number | participants | Pre-dose to 48 hours post-dose |
|
|
|
| Primary | Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) | Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Tmax. The mean Tmax value was adjusted to a 20 mg dose. | PK Population: patients who had adequate concentration-time data to permit estimation of noncompartmental PK parameters. One patient was not included in the analysis of nordiazepam due to receiving clorazepate, which interfered with the analysis of nordiazepam from diazepam administration. | Posted | Mean | Standard Deviation | hour (h) | Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours |
|
|
|
| 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 | Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter AUC(0-12) and AUC(last). The mean estimate of AUC(0-12) was adjusted to a 20 mg dose. AUC(last) was used for the calculation of AUC for nordiazepam. AUC(0-12) values could not be estimated for nordiazepam given that nordiazepam concentrations were rising between 6 and 12 hours. | PK Population: patients who had adequate concentration-time data to permit estimation of noncompartmental PK parameters. One patient was not included in the analysis of nordiazepam due to receiving clorazepate, which interfered with the analysis of nordiazepam from diazepam administration. | Posted | Mean | Standard Deviation | hour*nanogram/milliliter (h*ng/mL) | Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours |
|
|
|
| 0 |
| 31 |
| 28 |
| 31 |
| Dysgeusia | Nervous system disorders | MedDRA (14.0) |
|
| Somnolence | Nervous system disorders | MedDRA (14.0) |
|
| Dizziness | Nervous system disorders | MedDRA (14.0) |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Parosmia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.0) |
|
| Lacrimation increased | Eye disorders | MedDRA (14.0) |
|
| Fatigue | General disorders | MedDRA (14.0) |
|
| Catheter site pain | General disorders | MedDRA (14.0) |
|
| Feeling hot | General disorders | MedDRA (14.0) |
|
| Peripheral coldness | General disorders | MedDRA (14.0) |
|
| Tongue injury | Injury, poisoning and procedural complications | MedDRA (14.0) |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (14.0) |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.0) |
|
| Blood pressure increased | Investigations | MedDRA (14.0) |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) |
|
| Urinary retention | Renal and urinary disorders | MedDRA (14.0) |
|
Sponsor has right to review at least forty-five (45) days prior to the date of submission for publication or of public disclosure. Multi-center trials; publication shall be delayed until a publication of the multi-center results or until twelve (12) months have elapsed since the completion of the study, whichever occurs first.
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Total number of Treatment-Related TEAEs |
|
| Subjects with one or more Severe TEAEs |
|
| Total number of Severe TEAEs |
|
| Total number of Moderate TEAEs |
|
| Total number of Mild TEAEs |
|