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This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diazepam nasal spray (Adults) | Experimental | One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. |
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| Diazepam Nasal Spray (Adolescents) | Experimental | One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diazepam nasal spray | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Olfactory Changes as Measured by the Smell Identification Test (SIT) | The SIT is a 50-item multiple-choice standardized test of olfactory function. Scoring of the test in the ability to smell ranges from normal (Normosmia: score 35 - 40 Women; 34 - 40 Men); to inability to smell (Anosmia score 6 - 18); or Malingering (not engaged in the test) ranges 0 - 5. | Screening, weeks 12, 24, 36, 48 and 51 |
| Change From Baseline (Screening) in Nasal Mucosa. | Change from baseline treatment visits using a focused nasal exam was based on a scale of nasal irritation "none" to Grade 4 "septal perforation." | Screening, Weeks 12, 24, 36, 48 and 51 |
| Change in Taste as Measured by a Taste Change Questionnaire | Change in taste questionnaire was administered to subjects at every study visit only if the subject complained of a change in taste or as needed to report a related AE. The taste change profile included sweet, salty, sour, bitter, oily, sharp, chalky, metallic. The subject rated the change on a 10-point scale ranging from a weak change (1) to very strong (10). | Weeks 12, 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MinJae Lee | SK Biopharmaceuticals Co, Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acorda Site #227 | Phoenix | Arizona | 85054 | United States | ||
| Acorda Site #204 |
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Adolescents or adults who have refractory epilepsy (drug resistant epilepsy per Kwan 2010) with a history of cluster seizures, also known as multiple episodes of acute repetitive seizures, for which acute treatment with a benzodiazepine was indicated as part of the standard of care or an individualized rescue treatment plan.
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| ID | Title | Description |
|---|---|---|
| FG000 | DZNS - Adolescents (Ages 12 - 15) | One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. |
| FG001 | DZNS - Adults (Ages 16 - 65) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Acorda Site #213 | Los Angeles | California | 90095 | United States |
| Acorda Site #220 | Orange | California | 92868 | United States |
| Acorda Site #206 | Orlando | Florida | 32819 | United States |
| Acorda Site #241 | Port Charlotte | Florida | 33592 | United States |
| Acorda Site #231 | Tallahassee | Florida | 32308 | United States |
| Acorda Site #201 | Tampa | Florida | 33606 | United States |
| Acorda Site #234 | Tampa | Florida | 33609 | United States |
| Acorda Site #217 | Augusta | Georgia | 30912 | United States |
| Acorda Site #232 | Honolulu | Hawaii | 96817 | United States |
| Acorda Site #225 | Fort Wayne | Indiana | 46804 | United States |
| Acorda Site #226 | Ames | Iowa | 50010 | United States |
| Acorda Site #202 | Bethesda | Maryland | 20817 | United States |
| Acorda Site #212 | Boston | Massachusetts | 02115 | United States |
| Acorda Site #214 | Boston | Massachusetts | 02115 | United States |
| Acorda Site #208 | Boston | Massachusetts | 02215 | United States |
| Acorda Site #216 | Kansas City | Missouri | 64111 | United States |
| Acorda Site #205 | St Louis | Missouri | 63131 | United States |
| Acorda Site #222 | Hackensack | New Jersey | 07601 | United States |
| Acorda Site #223 | New York | New York | 10016 | United States |
| Acorda Site #233 | Rochester | New York | 14642 | United States |
| Acorda Site #230 | Portland | Oregon | 97239 | United States |
| Acorda Site #219 | Philadelphia | Pennsylvania | 19104 | United States |
| Acorda Site #237 | Philadelphia | Pennsylvania | 19107 | United States |
| Acorda Site #203 | Charleston | South Carolina | 29425 | United States |
| Acorda Site #235 | Memphis | Tennessee | 38103 | United States |
| Acorda Site #218 | Nashville | Tennessee | 37232 | United States |
| Acorda Site #221 | Dallas | Texas | 75251 | United States |
| Acorda Site #229 | Houston | Texas | 77030 | United States |
| Acorda Site #215 | Richmond | Virginia | 23298 | United States |
| Acorda Site #224 | Renton | Washington | 98057 | United States |
| Acorda Site #210 | Madison | Wisconsin | 53792 | United States |
One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diazapam Nasal Spray (DZNS) Adults | One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. |
| BG001 | Diazapam Nasal Spray (DZNS) Adolescents | One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Olfactory Changes as Measured by the Smell Identification Test (SIT) | The SIT is a 50-item multiple-choice standardized test of olfactory function. Scoring of the test in the ability to smell ranges from normal (Normosmia: score 35 - 40 Women; 34 - 40 Men); to inability to smell (Anosmia score 6 - 18); or Malingering (not engaged in the test) ranges 0 - 5. | Of 91 subjects in the Safety Population, data was available for 62 subjects at screening. | Posted | Count of Participants | Participants | Screening, weeks 12, 24, 36, 48 and 51 |
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| Primary | Change From Baseline (Screening) in Nasal Mucosa. | Change from baseline treatment visits using a focused nasal exam was based on a scale of nasal irritation "none" to Grade 4 "septal perforation." | Safety Population | Posted | Count of Participants | Participants | No | Screening, Weeks 12, 24, 36, 48 and 51 |
|
| |||||||||||||||||||||||||||||
| Primary | Change in Taste as Measured by a Taste Change Questionnaire | Change in taste questionnaire was administered to subjects at every study visit only if the subject complained of a change in taste or as needed to report a related AE. The taste change profile included sweet, salty, sour, bitter, oily, sharp, chalky, metallic. The subject rated the change on a 10-point scale ranging from a weak change (1) to very strong (10). | Safety Population - Number of subjects with at least one change in taste after dose administration. 6 Adults at 12 Weeks and 4 Adults at 24 weeks. No Adolescents participated. | Posted | Mean | Standard Deviation | units on a scale | Weeks 12, 24 |
|
|
1 year
Adverse events were reported on the safety population which included only those who received at least one dose of DZNS. Adults = 84 Adolescents = 7
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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 | Adults | One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. | 0 | 84 | 11 | 84 | 64 | 84 |
| EG001 | Adolescents | One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. | 0 | 7 | 1 | 7 | 5 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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| Oesophagitis Ulcerative | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Otitis Media | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Septic Shock | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Diebetes Mellitus | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Depressed Level of Consciousness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Status Epilepticus | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Status Migrainosus | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Psychogenic Seizure | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| Renal Failure Acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysgeusia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Nasal Mucosal Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA 17.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding the study results for a period up to 30 days from the date the communication is submitted to the sponsor. The sponsor shall have the right to defer proposed publication an additional 60 days from the end of the review period. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MinJae Lee, Associate Manager | SK Bio-pharmaceuticals Co, Ltd | minj.lee@sk.com |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Mild Microsmia |
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| Moderate Microsmia |
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| Severe Micromisia |
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| Anosmia |
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| Probable Malingering |
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| Week 12 |
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| Week 24 |
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| Week 36 |
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| Week 48 |
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| Week 51 |
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