Clinical trial NCT02316847: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Cluster Seizures
Seizures
Clusters
Acute repetitive seizures
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-12-15
Enrollment: 126
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Olfactory Changes as Measured by the Smell Identification Test (SIT)
timeFrame: Screening, weeks 12, 24, 36, 48 and 51
measure: Change From Baseline (Screening) in Nasal Mucosa.
timeFrame: Screening, Weeks 12, 24, 36, 48 and 51
measure: Change in Taste as Measured by a Taste Change Questionnaire
timeFrame: Weeks 12, 24
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Acorda Site #227
state: Arizona
city: Little Rock
country: United States
facility: Acorda Site #204
state: Arkansas
city: Los Angeles
country: United States
facility: Acorda Site #213
state: California
city: Orange
country: United States
facility: Acorda Site #220
state: California
city: Orlando
country: United States
facility: Acorda Site #206
state: Florida
city: Port Charlotte
country: United States
facility: Acorda Site #241
state: Florida
city: Tallahassee
country: United States
facility: Acorda Site #231
state: Florida
city: Tampa
country: United States
facility: Acorda Site #201
state: Florida
city: Tampa
country: United States
facility: Acorda Site #234
state: Florida
city: Augusta
country: United States
facility: Acorda Site #217
state: Georgia
city: Honolulu
country: United States
facility: Acorda Site #232
state: Hawaii
city: Fort Wayne
country: United States
facility: Acorda Site #225
state: Indiana
city: Ames
country: United States
facility: Acorda Site #226
state: Iowa
city: Bethesda
country: United States
facility: Acorda Site #202
state: Maryland
city: Boston
country: United States
facility: Acorda Site #212
state: Massachusetts
city: Boston
country: United States
facility: Acorda Site #214
state: Massachusetts
city: Boston
country: United States
facility: Acorda Site #208
state: Massachusetts
city: Kansas City
country: United States
facility: Acorda Site #216
state: Missouri
city: Saint Louis
country: United States
facility: Acorda Site #205
state: Missouri
city: Hackensack
country: United States
facility: Acorda Site #222
state: New Jersey
city: New York
country: United States
facility: Acorda Site #223
state: New York
city: Rochester
country: United States
facility: Acorda Site #233
state: New York
city: Portland
country: United States
facility: Acorda Site #230
state: Oregon
city: Philadelphia
country: United States
facility: Acorda Site #219
state: Pennsylvania
city: Philadelphia
country: United States
facility: Acorda Site #237
state: Pennsylvania
city: Charleston
country: United States
facility: Acorda Site #203
state: South Carolina
city: Memphis
country: United States
facility: Acorda Site #235
state: Tennessee
city: Nashville
country: United States
facility: Acorda Site #218
state: Tennessee
city: Dallas
country: United States
facility: Acorda Site #221
state: Texas
city: Houston
country: United States
facility: Acorda Site #229
state: Texas
city: Richmond
country: United States
facility: Acorda Site #215
state: Virginia
city: Renton
country: United States
facility: Acorda Site #224
state: Washington
city: Madison
country: United States
facility: Acorda Site #210
state: Wisconsin
Study officials:
affiliation: SK Biopharmaceuticals Co, Ltd
name: MinJae Lee
role: STUDY_DIRECTOR
References: