Trial · NCT02474407
Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
NCT02474407, Phase 2, Terminated, Acorda Therapeutics; results first posted 2018-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®). Trials, record NCT02474407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02474407
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
- NCT number
- NCT02474407
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 78 participants, actual
- Lead sponsor
- Acorda Therapeutics
- Conditions
- Refractory Epilepsy
- Interventions
- diazepam nasal spray, diazepam rectal gel
- First posted
- 2015-06-17
- Last updated
- 2018-10-16
- Results first posted
- 2018-10-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | AUC 0-24h | 24 hours | Relative bioavailability based on area under time plasma concentration curve. |
| Primary | Cmax | 24 hours | Relative bioavailability based on maximum observed plasma concentration. |
| Secondary | Focused Nasal Exam (Part A) | pre-dose (day 1) up to 24 hours post-dose | A focused nasal exam was completed by the Investigator in the treatment period(s) when diazepam nasal spray was administered, based on a visual inspection of the nasal mucosa. Nasal irritation will be graded "none" to Grade 4 "septal perforation." Grade 1a= focal irritation, Grade 1b= superficial mucosal erosion, Grade 2= moderate mucosal erosion, Grade 3= ulceration, Grade 4= septal perforation. This exam may be conducted within a 5 minute window after the specified time point. Between the 12 and 24 h time points, the exam should be repeated every 4 hours as needed to follow any residual symptoms to resolution and the time of resolution should be documented. (Categories with no data were omitted) |
| Secondary | Focused Nasal Exam (Part B) | pre-dose (day 1) up to 24 hours post-dose | A focused nasal exam was completed by the Investigator in the treatment period(s) when diazepam nasal spray was administered, based on a visual inspection of the nasal mucosa. Focused Nasal Examination Part B - will show nasal mucosal symptoms that will be rated for severity will include discharge, mucosal edema, crusting, erythema, and epistaxis. This exam may be conducted within a 5 minute window after the specified time point. Between the 12 and 24 h time points, the exam was should be repeated every 4 hours as needed to follow any residual symptoms to resolution and the time of resolution should be documented. (Categories with no data were omitted) |
| Secondary | Smell Identification Test (SIT) | day 1 up to day 31 | The SIT is a validated test of smell identification which scores patients into different levels of olfactory function normalized by age and gender, however it had not been validated for use in PWE. The Smell Identification Test (SIT) is a 40-item multiple-choice standardized test. The test can be self-administered and consists of four 10-page booklets with a different "scratch and sniff" strip on each page. A scratch with a pencil releases the scent from the strip, and the subject is then asked to match the scent to one of four choices on the page. An answer must be selected for each of the 40 items, even when the subject cannot detect a smell. The total score (i.e., number of correct answers, range: 0-40) can be compared against normative data collected from approximately 4000 normal individuals between ages 4 to 99 to determine the subject's percentile rank of olfactory dysfunction corrected for age and gender. |
| Secondary | Taste Change Questionnaire | Up to 24 hours | Questionnaire given to safety population in Cohort 1 for reporting taste change during the study. If the subject spontaneously reports an experience of taste change associated with diazepam nasal spray dosing, it will be evaluated qualitatively by the research staff using a taste change questionnaire. The subject will be asked to describe the type, intensity, and duration of the change in taste at multiple scheduled time points after dosing. Between the 12 and 24 h time points, the questionnaire should be repeated every 4 hours as needed to follow any residual symptoms to resolution, and time of resolution should be documented. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | AUC 0-24h | 24 hours | ng*h/mL | MEAN | |
| PRIMARY | Cmax | 24 hours | ng/mL | MEAN | |
| SECONDARY | Focused Nasal Exam (Part A) | pre-dose (day 1) up to 24 hours post-dose | Safety population Cohort 1. (Accessed only for DZNS Arm) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Focused Nasal Exam (Part B) | pre-dose (day 1) up to 24 hours post-dose | The Safety population / Cohort 1. (Accessed only for DZNS Arm) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Smell Identification Test (SIT) | day 1 up to day 31 | Safety Population / Cohort 1. (Accessed only for DZNS Arm) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Taste Change Questionnaire | Up to 24 hours | Safety Population / Cohort 1. (Accessed only for DZNS Arm) | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group145
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| AUC 0-24h | Single Dose of Diazapam Nasal Spray (DZNS) | 1357.7 | Standard Deviation 802.78 | ng*h/mL | |
| AUC 0-24h | Single Dose of Diazapam Rectal Gel (DRG) | 2117.9 | Standard Deviation 996.27 | ng*h/mL | |
| Cmax | Single Dose of Diazapam Nasal Spray (DZNS) | 157.0 | Standard Deviation 120.15 | ng/mL | |
| Cmax | Single Dose of Diazapam Rectal Gel (DRG) | 309.3 | Standard Deviation 137.95 | ng/mL | |
| Focused Nasal Exam (Part A) | DZNS - At 24 Hours Post-Dose - NONE | Nasal Irritation at Baseline - NONE | 64 | Participants | |
| Focused Nasal Exam (Part A) | DZNS - At 24 Hours Post-Dose - Grade 1a | Nasal Irritation at Baseline - NONE | 6 | Participants | |
| Focused Nasal Exam (Part A) | DZNS - At 24 Hours Post-Dose - Grade 1b | Nasal Irritation at Baseline - NONE | 0 | Participants | |
| Focused Nasal Exam (Part A) | DZNS - At 24 Hours Post-Dose - Grade 2 | Nasal Irritation at Baseline - NONE | 1 | Participants | |
| Focused Nasal Exam (Part A) | DZNS - At 24 Hours Post-Dose - Grade 3 | Nasal Irritation at Baseline - NONE | 0 | Participants | |
| Focused Nasal Exam (Part A) | DZNS - At 24 Hours Post-Dose - Grade 4 | Nasal Irritation at Baseline - NONE | 0 | Participants |
1 to 10 of 145Source ClinicalTrials.gov
See all 145 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (14 Days) | STARTED | Single Dose of Diazapam Nasal Spray (DZNS) | 39 | |
| First Intervention (14 Days) | STARTED | Single Dose of Diazapam Rectal Gel (DRG) | 39 | |
| First Intervention (14 Days) | COMPLETED | Single Dose of Diazapam Nasal Spray (DZNS) | 39 | |
| First Intervention (14 Days) | COMPLETED | Single Dose of Diazapam Rectal Gel (DRG) | 39 | |
| First Intervention (14 Days) | NOT COMPLETED | Single Dose of Diazapam Nasal Spray (DZNS) | 0 | |
| First Intervention (14 Days) | NOT COMPLETED | Single Dose of Diazapam Rectal Gel (DRG) | 0 | |
| Washout (14 Days) | STARTED | Single Dose of Diazapam Nasal Spray (DZNS) | 39 | |
| Washout (14 Days) | STARTED | Single Dose of Diazapam Rectal Gel (DRG) | 39 | |
| Washout (14 Days) | COMPLETED | Single Dose of Diazapam Nasal Spray (DZNS) | 39 | |
| Washout (14 Days) | COMPLETED | Single Dose of Diazapam Rectal Gel (DRG) | 39 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasal Discomfort | General disorders | Diazepam Nasal Spray | 30 | 78 | |
| other | Nasal Discomfort | General disorders | Diazepam Rectal Gel | 3 | 78 | |
| other | Dysgeusia | General disorders | Diazepam Nasal Spray | 25 | 78 | |
| other | Dysgeusia | General disorders | Diazepam Rectal Gel | 0 | 78 | |
| other | Lacrimation Increased | General disorders | Diazepam Nasal Spray | 22 | 78 | |
| other | Lacrimation Increased | General disorders | Diazepam Rectal Gel | 0 | 78 | |
| other | Nasal Mucosal Disorder | General disorders | Diazepam Nasal Spray | 10 | 78 | |
| other | Nasal Mucosal Disorder | General disorders | Diazepam Rectal Gel | 2 | 78 | |
| other | Rhinorrhea | General disorders | Diazepam Nasal Spray | 10 | 78 | |
| other | Rhinorrhea | General disorders | Diazepam Rectal Gel | 1 | 78 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diazepam Nasal Spray | 0 | 78 |
| Total, all-cause mortality | Diazepam Rectal Gel | 0 | 78 |
| Total, other adverse events | Diazepam Nasal Spray | 60 | 78 |
| Total, other adverse events | Diazepam Rectal Gel | 20 | 78 |
| Total, serious adverse events | Diazepam Nasal Spray | 0 | 78 |
| Total, serious adverse events | Diazepam Rectal Gel | 0 | 78 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Diazepam Nasal Spray vs Diazepam Rectal Gel: deaths from any cause | Trial comparisons |
| Diazepam Nasal Spray vs Diazepam Rectal Gel: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02474407
GET https://conductscience.org/api/trials/v1/NCT02474407/results?page=2