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TERMINATEDPHASE2

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

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.

NCT02316847•Acorda Therapeutics

View on ClinicalTrials.gov

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

Age

12 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (33)

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

Key Dates

Start Date

December 1, 2014

Primary Completion Date

July 1, 2016

Completion Date

September 1, 2016

Last Updated

July 30, 2018

Enrollment

126

ACTUAL participants

Conditions

Epilepsy

Interventions

diazepam nasal spray

DRUG

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Epilepsy; Seizure

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

MEHMO Natural History and Biomarkers