An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
NCT ID: NCT02316847
Last Updated: 2018-07-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
126 participants
INTERVENTIONAL
2014-12-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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diazepam nasal spray (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.
diazepam nasal spray
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.
diazepam nasal spray
Interventions
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diazepam nasal spray
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
65 Years
ALL
No
Sponsors
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Acorda Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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MinJae Lee
Role: STUDY_DIRECTOR
SK Biopharmaceuticals Co, Ltd
Locations
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Acorda Site #227
Phoenix, Arizona, United States
Acorda Site #204
Little Rock, Arkansas, United States
Acorda Site #213
Los Angeles, California, United States
Acorda Site #220
Orange, California, United States
Acorda Site #206
Orlando, Florida, United States
Acorda Site #241
Port Charlotte, Florida, United States
Acorda Site #231
Tallahassee, Florida, United States
Acorda Site #201
Tampa, Florida, United States
Acorda Site #234
Tampa, Florida, United States
Acorda Site #217
Augusta, Georgia, United States
Acorda Site #232
Honolulu, Hawaii, United States
Acorda Site #225
Fort Wayne, Indiana, United States
Acorda Site #226
Ames, Iowa, United States
Acorda Site #202
Bethesda, Maryland, United States
Acorda Site #212
Boston, Massachusetts, United States
Acorda Site #214
Boston, Massachusetts, United States
Acorda Site #208
Boston, Massachusetts, United States
Acorda Site #216
Kansas City, Missouri, United States
Acorda Site #205
St Louis, Missouri, United States
Acorda Site #222
Hackensack, New Jersey, United States
Acorda Site #223
New York, New York, United States
Acorda Site #233
Rochester, New York, United States
Acorda Site #230
Portland, Oregon, United States
Acorda Site #219
Philadelphia, Pennsylvania, United States
Acorda Site #237
Philadelphia, Pennsylvania, United States
Acorda Site #203
Charleston, South Carolina, United States
Acorda Site #235
Memphis, Tennessee, United States
Acorda Site #218
Nashville, Tennessee, United States
Acorda Site #221
Dallas, Texas, United States
Acorda Site #229
Houston, Texas, United States
Acorda Site #215
Richmond, Virginia, United States
Acorda Site #224
Renton, Washington, United States
Acorda Site #210
Madison, Wisconsin, United States
Countries
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Other Identifiers
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DZNS-EP-1025
Identifier Type: -
Identifier Source: org_study_id
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