An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.



Status:Terminated
Conditions:Neurology, Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:12 - 65
Updated:8/1/2018
Start Date:December 2014
End Date:September 2016

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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.

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).


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
We found this trial at
32
sites
Hackensack, New Jersey 07601
2430
mi
from 91732
Hackensack, NJ
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Ames, Iowa 50010
1430
mi
from 91732
Ames, IA
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Augusta, Georgia 30912
2058
mi
from 91732
Augusta, GA
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Bethesda, Maryland 20817
2277
mi
from 91732
Bethesda, MD
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Boston, Massachusetts 02118
2577
mi
from 91732
Boston, MA
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Boston, Massachusetts 02118
2577
mi
from 91732
Boston, MA
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Boston, Massachusetts 02118
2577
mi
from 91732
Boston, MA
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Charleston, South Carolina 29425
2183
mi
from 91732
Charleston, SC
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Dallas, Texas 75214
1226
mi
from 91732
Dallas, TX
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Fort Wayne, Indiana 46804
1846
mi
from 91732
Fort Wayne, IN
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Honolulu, Hawaii 96734
2573
mi
from 91732
Honolulu, HI
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Kansas City, Missouri 64132
1341
mi
from 91732
Kansas City, MO
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Little Rock, Arkansas 72205
1459
mi
from 91732
Little Rock, AR
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Los Angeles, California 90033
11
mi
from 91732
Los Angeles, CA
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Madison, Wisconsin 53792
1655
mi
from 91732
Madison, WI
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Memphis, Tennessee 38163
1586
mi
from 91732
Memphis, TN
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Nashville, Tennessee 37232
1762
mi
from 91732
Nashville, TN
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New York, New York 10016
2434
mi
from 91732
New York, NY
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Orange, California 92868
21
mi
from 91732
Orange, CA
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Orlando, Florida 32806
2186
mi
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Orlando, FL
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Philadelphia, Pennsylvania 19107
2375
mi
from 91732
Philadelphia, PA
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Phoenix, Arizona 85054
343
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Phoenix, AZ
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Port Charlotte, Florida 33980
2183
mi
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Port Charlotte, FL
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Portland, Oregon 97239
826
mi
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Portland, OR
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Renton, Washington 98057
951
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Renton, WA
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Richmond, Virginia 23298
2268
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Richmond, VA
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Rochester, New York 14642
2245
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Rochester, NY
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Saint Louis, Missouri 63131
1573
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Saint Louis, MO
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Tallahassee, Florida 32308
1980
mi
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Tallahassee, FL
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Tampa, Florida 33613
2132
mi
from 91732
Tampa, FL
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Tampa, Florida 33613
2132
mi
from 91732
Tampa, FL
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