Back to resultsAn Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
Primary Purpose
Epilepsy
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
diazepam nasal spray
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Cluster Seizures, Seizures, Clusters, Acute repetitive seizures
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of drug-resistant epilepsy
- Patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (AED)
- Occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the Screening Visit
- A caregiver must consent to participate together with the subject for purposes of observation and data collection
- The caregiver must be present when the investigational product is administered
- Screening body weight between 26 to 111 kg, inclusive
Exclusion Criteria:
- Female subject who is pregnant, breastfeeding, or planning to become pregnant
- Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
- Known allergy or hypersensitivity to diazepam, related drugs, or any of the formulation components
- Positive screening test for ethanol or other drugs of abuse
- Unable to receive medications intranasally
Sites / Locations
- Acorda Site #227
- Acorda Site #204
- Acorda Site #213
- Acorda Site #220
- Acorda Site #206
- Acorda Site #241
- Acorda Site #231
- Acorda Site #201
- Acorda Site #234
- Acorda Site #217
- Acorda Site #232
- Acorda Site #225
- Acorda Site #226
- Acorda Site #202
- Acorda Site #212
- Acorda Site #214
- Acorda Site #208
- Acorda Site #216
- Acorda Site #205
- Acorda Site #222
- Acorda Site #223
- Acorda Site #233
- Acorda Site #230
- Acorda Site #219
- Acorda Site #237
- Acorda Site #203
- Acorda Site #235
- Acorda Site #218
- Acorda Site #221
- Acorda Site #229
- Acorda Site #215
- Acorda Site #224
- Acorda Site #210
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
diazepam nasal spray (Adults)
Diazepam Nasal Spray (Adolescents)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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."
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02316847
Brief Title
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
Official Title
Multi-center, Open-label, Study of Safety and Tolerability of Chronic Intermittent Usage of Diazepam Nasal Spray in Adolescents and Adult Patients With Cluster Seizures, Including Assessment of Olfaction and Reported Changes in Taste.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Cluster Seizures, Seizures, Clusters, Acute repetitive seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diazepam nasal spray (Adults)
Arm Type
Experimental
Arm Description
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.
Arm Title
Diazepam Nasal Spray (Adolescents)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
diazepam nasal spray
Primary Outcome Measure Information:
Title
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Description
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.
Time Frame
Screening, weeks 12, 24, 36, 48 and 51
Title
Change From Baseline (Screening) in Nasal Mucosa.
Description
Change from baseline treatment visits using a focused nasal exam was based on a scale of nasal irritation "none" to Grade 4 "septal perforation."
Time Frame
Screening, Weeks 12, 24, 36, 48 and 51
Title
Change in Taste as Measured by a Taste Change Questionnaire
Description
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).
Time Frame
Weeks 12, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of drug-resistant epilepsy
Patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (AED)
Occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the Screening Visit
A caregiver must consent to participate together with the subject for purposes of observation and data collection
The caregiver must be present when the investigational product is administered
Screening body weight between 26 to 111 kg, inclusive
Exclusion Criteria:
Female subject who is pregnant, breastfeeding, or planning to become pregnant
Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
Known allergy or hypersensitivity to diazepam, related drugs, or any of the formulation components
Positive screening test for ethanol or other drugs of abuse
Unable to receive medications intranasally
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MinJae Lee
Organizational Affiliation
SK Biopharmaceuticals Co, Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Acorda Site #227
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Acorda Site #204
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Acorda Site #213
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Acorda Site #220
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Acorda Site #206
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Acorda Site #241
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33592
Country
United States
Facility Name
Acorda Site #231
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Acorda Site #201
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Acorda Site #234
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Acorda Site #217
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Acorda Site #232
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Acorda Site #225
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Acorda Site #226
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Acorda Site #202
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Acorda Site #212
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Acorda Site #214
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Acorda Site #208
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Acorda Site #216
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Acorda Site #205
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Acorda Site #222
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Acorda Site #223
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Acorda Site #233
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Acorda Site #230
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Acorda Site #219
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Acorda Site #237
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Acorda Site #203
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Acorda Site #235
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Acorda Site #218
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Acorda Site #221
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Acorda Site #229
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Acorda Site #215
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Acorda Site #224
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Acorda Site #210
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
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