Trial Outcomes & Findings for An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray. (NCT NCT02316847)
NCT ID: NCT02316847
Last Updated: 2018-07-30
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
126 participants
Primary outcome timeframe
Screening, weeks 12, 24, 36, 48 and 51
Results posted on
2018-07-30
Participant Flow
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.
Participant milestones
| Measure |
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.
|
DZNS - Adults (Ages 16 - 65)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
99
|
|
Overall Study
COMPLETED
|
0
|
13
|
|
Overall Study
NOT COMPLETED
|
9
|
86
|
Reasons for withdrawal
| Measure |
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.
|
DZNS - Adults (Ages 16 - 65)
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
9
|
|
Overall Study
Noncompliance with study drug
|
0
|
3
|
|
Overall Study
Withdrawn due to termination by Sponsor
|
7
|
67
|
Baseline Characteristics
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
Baseline characteristics by cohort
| Measure |
Diazapam Nasal Spray (DZNS) Adults
n=99 Participants
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.
|
Diazapam Nasal Spray (DZNS) Adolescents
n=9 Participants
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.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
91 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
34.6 years
STANDARD_DEVIATION 12.58 • n=5 Participants
|
13.4 years
STANDARD_DEVIATION 1.13 • n=7 Participants
|
32.9 years
STANDARD_DEVIATION 13.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
99 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening, weeks 12, 24, 36, 48 and 51Population: Of 91 subjects in the Safety Population, data was available for 62 subjects at screening.
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.
Outcome measures
| Measure |
Diazepam Nasal Spray (Adults)
n=57 Participants
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.
|
Diazepam Nasal Spray (Adolescents)
n=5 Participants
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.
|
|---|---|---|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Screening · Normosmia
|
18 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Screening · Mild Microsmia
|
15 Participants
|
1 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Screening · Moderate Microsmia
|
8 Participants
|
3 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Screening · Severe Micromisia
|
7 Participants
|
1 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Screening · Anosmia
|
9 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Screening · Probable Malingering
|
0 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 12 · Normosmia
|
6 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 12 · Mild Microsmia
|
16 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 12 · Moderate Microsmia
|
9 Participants
|
1 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 12 · Severe Micromisia
|
1 Participants
|
2 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 12 · Anosmia
|
2 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 12 · Probable Malingering
|
0 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 24 · Normosmia
|
5 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 24 · Mild Microsmia
|
9 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 24 · Moderate Microsmia
|
2 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 24 · Severe Micromisia
|
5 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 24 · Anosmia
|
0 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 24 · Probable Malingering
|
0 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 36 · Normosmia
|
2 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 36 · Mild Microsmia
|
6 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 36 · Moderate Microsmia
|
4 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 36 · Severe Micromisia
|
1 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 36 · Anosmia
|
1 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 36 · Probable Malingering
|
0 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 48 · Normosmia
|
0 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 48 · Mild Microsmia
|
5 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 48 · Moderate Microsmia
|
1 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 48 · Severe Micromisia
|
3 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 48 · Anosmia
|
1 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 48 · Probable Malingering
|
0 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 51 · Normosmia
|
1 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 51 · Mild Microsmia
|
3 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 51 · Moderate Microsmia
|
1 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 51 · Severe Micromisia
|
4 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 51 · Anosmia
|
1 Participants
|
0 Participants
|
|
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Week 51 · Probable Malingering
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening, Weeks 12, 24, 36, 48 and 51Population: Safety Population
Change from baseline treatment visits using a focused nasal exam was based on a scale of nasal irritation "none" to Grade 4 "septal perforation."
Outcome measures
| Measure |
Diazepam Nasal Spray (Adults)
n=84 Participants
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.
|
Diazepam Nasal Spray (Adolescents)
n=7 Participants
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.
|
|---|---|---|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 48: Crusting of Mucosa None
|
13 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Nasal Irritation None
|
67 Participants
|
6 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Nasal Irritation Grade 1a
|
10 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Nasal Irritation Grade 1b
|
3 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Nasal Irritation Grade 2
|
0 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Mucosal Edema None
|
71 Participants
|
6 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Mucosal Edema Mild
|
9 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Nasal Discharge None
|
66 Participants
|
6 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Nasal Discharge Mild
|
14 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Mucosal Erythema None
|
65 Participants
|
5 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Mucosal Erythema Mild
|
13 Participants
|
2 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Mucosal Erythema Moderate
|
2 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Mucosal Bleeding/Epistaxis None
|
79 Participants
|
6 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Mucosal Bleeding/Epistaxis Mild
|
1 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Crusting of Mucosa None
|
77 Participants
|
7 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Screening : Crusting of Mucosa Mild
|
3 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Nasal Irritation None
|
50 Participants
|
4 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Nasal Irritation Grade 1a
|
5 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Nasal Irritation Grade 1b
|
3 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Nasal Irritation Grade 2
|
1 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Mucosal Edema None
|
55 Participants
|
3 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Mucosal Edema Mild
|
4 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Nasal Discharge None
|
49 Participants
|
4 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Nasal Discharge Mild
|
10 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Mucosal Erythema None
|
39 Participants
|
4 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Mucosal Erythema Mild
|
20 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Mucosal Erythema Moderate
|
0 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Mucosal Bleeding/Epistaxis None
|
58 Participants
|
4 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Mucosal Bleeding/Epistaxis Mild
|
1 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Crusting of Mucosa None
|
58 Participants
|
4 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 12 : Crusting of Mucosa Mild
|
1 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 24: Nasal Irritation None
|
37 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 24: Nasal Irritation Grade 1a
|
1 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 24: Nasal Irritation Grade 1b
|
1 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 24: Mucosal Edema None
|
35 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 24: Mucosal Edema Mild
|
4 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 24: Nasal Discharge None
|
31 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 24: Nasal Discharge Mild
|
8 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 24: Mucosal Erythema None
|
33 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 24: Mucosal Erythema Mild
|
6 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 24: Mucosal Bleeding/Epistaxis None
|
39 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 24: Crusting of Mucosa None
|
37 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 24: Crusting of Mucosa Mild
|
2 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 36: Nasal Irritation None
|
21 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 36: Nasal Irritation Grade 1a
|
1 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 36: Mucosal Edema None
|
21 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 36: Mucosal Edema Mild
|
1 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 36: Nasal Discharge None
|
20 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 36: Nasal Discharge Mild
|
1 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 36: Mucosal Erythema None
|
20 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 36: Mucosal Erythema Mild
|
2 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 36: Mucosal Bleeding/Epistaxis None
|
22 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 36: Crusting of Mucosa None
|
21 Participants
|
1 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 36: Crusting of Mucosa Mild
|
1 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 48: Nasal Irritation None
|
12 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 48: Nasal Irritation Grade 1a
|
1 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 48: Mucosal Edema None
|
13 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 48: Nasal Discharge None
|
13 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 48: Mucosal Erythema None
|
13 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 48: Mucosal Bleeding/Epistaxis None
|
13 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 51: Nasal Irritation None
|
13 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 51: Mucosal Edema None
|
13 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 51: Nasal Discharge None
|
12 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 51: Nasal Discharge Mild
|
1 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 51: Mucosal Erythema None
|
13 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 51: Mucosal Bleeding/Epistaxis None
|
13 Participants
|
0 Participants
|
|
Change From Baseline (Screening) in Nasal Mucosa.
Week 51: Crusting of Mucosa None
|
13 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Weeks 12, 24Population: 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.
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).
Outcome measures
| Measure |
Diazepam Nasal Spray (Adults)
n=84 Participants
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.
|
Diazepam Nasal Spray (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.
|
|---|---|---|
|
Change in Taste as Measured by a Taste Change Questionnaire
Week 24
|
8.3 units on a scale
Standard Deviation 0.50
|
—
|
|
Change in Taste as Measured by a Taste Change Questionnaire
Week 12
|
7.7 units on a scale
Standard Deviation 2.73
|
—
|
Adverse Events
Adults
Serious events: 11 serious events
Other events: 64 other events
Deaths: 0 deaths
Adolescents
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adults
n=84 participants at risk
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.
|
Adolescents
n=7 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Gastrointestinal disorders
Oesophagitis Ulcerative
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Infections and infestations
Otitis Media
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Infections and infestations
Septic Shock
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Metabolism and nutrition disorders
Diebetes Mellitus
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Nervous system disorders
Convulsion
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Nervous system disorders
Depressed Level of Consciousness
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Nervous system disorders
Migraine
|
2.4%
2/84 • 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
|
0.00%
0/7 • 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
|
|
Nervous system disorders
Status Epilepticus
|
3.6%
3/84 • 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
|
14.3%
1/7 • 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
|
|
Nervous system disorders
Status Migrainosus
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Psychiatric disorders
Psychogenic Seizure
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.2%
1/84 • 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
|
0.00%
0/7 • 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
|
Other adverse events
| Measure |
Adults
n=84 participants at risk
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.
|
Adolescents
n=7 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
29.8%
25/84 • 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
|
28.6%
2/7 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Dysgeusia
|
17.9%
15/84 • 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
|
0.00%
0/7 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Mucosal Disorder
|
7.1%
6/84 • 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
|
14.3%
1/7 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.5%
8/84 • 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
|
14.3%
1/7 • 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
|
|
Injury, poisoning and procedural complications
Overdose
|
7.1%
6/84 • 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
|
0.00%
0/7 • 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
|
|
Eye disorders
Lacrimation increased
|
8.3%
7/84 • 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
|
14.3%
1/7 • 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
|
|
Nervous system disorders
Somnolence
|
7.1%
6/84 • 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
|
0.00%
0/7 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
8.3%
7/84 • 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
|
0.00%
0/7 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER