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

Phase 2

Terminated

• Conditions: Epilepsy
• Interventions: Drug: diazepam nasal spray

• Registration Number: NCT02316847
• Lead Sponsor: Acorda Therapeutics

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-15
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Results First Submitted: 2017-11-08
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-27
• Last Update Submitted: 2018-07-27
• Results First Posted: 2018-07-30
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 126

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
diazepam nasal spray (Adults)	diazepam nasal spray	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 (Adolescents)	diazepam nasal spray	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.

Primary Outcome Measures

Name	Time	Method
Olfactory Changes as Measured by the Smell Identification Test (SIT)	Screening, weeks 12, 24, 36, 48 and 51	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.	Screening, Weeks 12, 24, 36, 48 and 51	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	Weeks 12, 24	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).

Trial Locations

Locations (33)

Acorda Site #237; 🇺🇸 Philadelphia, Pennsylvania, United States

Acorda Site #231; 🇺🇸 Tallahassee, Florida, United States

Acorda Site #202; 🇺🇸 Bethesda, Maryland, United States

Acorda Site #217; 🇺🇸 Augusta, Georgia, United States

Acorda Site #235; 🇺🇸 Memphis, Tennessee, United States

Acorda Site #222; 🇺🇸 Hackensack, New Jersey, United States

Acorda Site #224; 🇺🇸 Renton, Washington, United States

Acorda Site #241; 🇺🇸 Port Charlotte, Florida, United States

Acorda Site #221; 🇺🇸 Dallas, Texas, United States

Acorda Site #227; 🇺🇸 Phoenix, Arizona, United States

Acorda Site #204; 🇺🇸 Little Rock, Arkansas, United States

Acorda Site #203; 🇺🇸 Charleston, South Carolina, United States

Acorda Site #206; 🇺🇸 Orlando, Florida, United States

Acorda Site #220; 🇺🇸 Orange, California, United States

Acorda Site #223; 🇺🇸 New York, New York, United States

Acorda Site #232; 🇺🇸 Honolulu, Hawaii, United States

Acorda Site #213; 🇺🇸 Los Angeles, California, United States

Acorda Site #218; 🇺🇸 Nashville, Tennessee, United States

Acorda Site #219; 🇺🇸 Philadelphia, Pennsylvania, United States

Acorda Site #225; 🇺🇸 Fort Wayne, Indiana, United States

Acorda Site #208; 🇺🇸 Boston, Massachusetts, United States

Acorda Site #230; 🇺🇸 Portland, Oregon, United States

Acorda Site #229; 🇺🇸 Houston, Texas, United States

Acorda Site #205; 🇺🇸 Saint Louis, Missouri, United States

Acorda Site #233; 🇺🇸 Rochester, New York, United States

Acorda Site #212; 🇺🇸 Boston, Massachusetts, United States

Acorda Site #210; 🇺🇸 Madison, Wisconsin, United States

Acorda Site #215; 🇺🇸 Richmond, Virginia, United States

Acorda Site #226; 🇺🇸 Ames, Iowa, United States

Acorda Site #234; 🇺🇸 Tampa, Florida, United States

Acorda Site #201; 🇺🇸 Tampa, Florida, United States

Acorda Site #216; 🇺🇸 Kansas City, Missouri, United States

Acorda Site #214; 🇺🇸 Boston, Massachusetts, United States