Trial · NCT02316847
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
NCT02316847, Phase 2, Terminated, Acorda Therapeutics; results first posted 2018-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray. Trials, record NCT02316847. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02316847
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
- NCT number
- NCT02316847
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 126 participants, actual
- Lead sponsor
- Acorda Therapeutics
- Conditions
- Epilepsy
- Interventions
- diazepam nasal spray
- First posted
- 2014-12-15
- Last updated
- 2018-07-30
- Results first posted
- 2018-07-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Olfactory Changes as Measured by the Smell Identification Test (SIT) | Screening, weeks 12, 24, 36, 48 and 51 | 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. |
| Primary | Change From Baseline (Screening) in Nasal Mucosa. | Screening, Weeks 12, 24, 36, 48 and 51 | Change from baseline treatment visits using a focused nasal exam was based on a scale of nasal irritation "none" to Grade 4 "septal perforation." |
| Primary | Change in Taste as Measured by a Taste Change Questionnaire | Weeks 12, 24 | 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). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Olfactory Changes as Measured by the Smell Identification Test (SIT) | Screening, weeks 12, 24, 36, 48 and 51 | Of 91 subjects in the Safety Population, data was available for 62 subjects at screening. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline (Screening) in Nasal Mucosa. | Screening, Weeks 12, 24, 36, 48 and 51 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Taste as Measured by a Taste Change Questionnaire | Weeks 12, 24 | 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. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group208
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Olfactory Changes as Measured by the Smell Identification Test (SIT) | Diazepam Nasal Spray (Adults) | Screening / Normosmia | 18 | Participants | |
| Olfactory Changes as Measured by the Smell Identification Test (SIT) | Diazepam Nasal Spray (Adolescents) | Screening / Normosmia | 0 | Participants | |
| Olfactory Changes as Measured by the Smell Identification Test (SIT) | Diazepam Nasal Spray (Adults) | Screening / Mild Microsmia | 15 | Participants | |
| Olfactory Changes as Measured by the Smell Identification Test (SIT) | Diazepam Nasal Spray (Adolescents) | Screening / Mild Microsmia | 1 | Participants | |
| Olfactory Changes as Measured by the Smell Identification Test (SIT) | Diazepam Nasal Spray (Adults) | Screening / Moderate Microsmia | 8 | Participants | |
| Olfactory Changes as Measured by the Smell Identification Test (SIT) | Diazepam Nasal Spray (Adolescents) | Screening / Moderate Microsmia | 3 | Participants | |
| Olfactory Changes as Measured by the Smell Identification Test (SIT) | Diazepam Nasal Spray (Adults) | Screening / Severe Micromisia | 7 | Participants | |
| Olfactory Changes as Measured by the Smell Identification Test (SIT) | Diazepam Nasal Spray (Adolescents) | Screening / Severe Micromisia | 1 | Participants | |
| Olfactory Changes as Measured by the Smell Identification Test (SIT) | Diazepam Nasal Spray (Adults) | Screening / Anosmia | 9 | Participants | |
| Olfactory Changes as Measured by the Smell Identification Test (SIT) | Diazepam Nasal Spray (Adolescents) | Screening / Anosmia | 0 | Participants |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DZNS - Adolescents (Ages 12 - 15) | 9 | |
| Overall Study | STARTED | DZNS - Adults (Ages 16 - 65) | 99 | |
| Overall Study | COMPLETED | DZNS - Adolescents (Ages 12 - 15) | 0 | |
| Overall Study | COMPLETED | DZNS - Adults (Ages 16 - 65) | 13 | |
| Overall Study | NOT COMPLETED | DZNS - Adolescents (Ages 12 - 15) | 9 | |
| Overall Study | NOT COMPLETED | DZNS - Adults (Ages 16 - 65) | 86 |
Source ClinicalTrials.gov
Adverse events54
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 | Respiratory, thoracic and mediastinal disorders | Adults | 25 | 84 | |
| other | Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | Adolescents | 2 | 7 | |
| other | Dysgeusia | Respiratory, thoracic and mediastinal disorders | Adults | 15 | 84 | |
| other | Dysgeusia | Respiratory, thoracic and mediastinal disorders | Adolescents | 0 | 7 | |
| other | Nasal Mucosal Disorder | Respiratory, thoracic and mediastinal disorders | Adults | 6 | 84 | |
| other | Nasal Mucosal Disorder | Respiratory, thoracic and mediastinal disorders | Adolescents | 1 | 7 | |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Adults | 8 | 84 | |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Adolescents | 1 | 7 | |
| other | Overdose | Injury, poisoning and procedural complications | Adults | 6 | 84 | |
| other | Overdose | Injury, poisoning and procedural complications | Adolescents | 0 | 7 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adults | 0 | 84 |
| Total, all-cause mortality | Adolescents | 0 | 7 |
| Total, other adverse events | Adults | 64 | 84 |
| Total, other adverse events | Adolescents | 5 | 7 |
| Total, serious adverse events | Adults | 11 | 84 |
| Total, serious adverse events | Adolescents | 1 | 7 |
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 |
|---|---|
| Adults vs Adolescents: deaths from any cause | Trial comparisons |
| Adults vs Adolescents: 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/NCT02316847
GET https://conductscience.org/api/trials/v1/NCT02316847/results?page=2