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.

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).

Study Overview

• Status: Terminated
• Conditions: Epilepsy
• Intervention / Treatment: Drug: diazepam nasal spray

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Acorda Site #227
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Acorda Site #204
  • California
    • Los Angeles, California, United States, 90095
      • Acorda Site #213
    • Orange, California, United States, 92868
      • Acorda Site #220
  • Florida
    • Orlando, Florida, United States, 32819
      • Acorda Site #206
    • Port Charlotte, Florida, United States, 33592
      • Acorda Site #241
    • Tallahassee, Florida, United States, 32308
      • Acorda Site #231
    • Tampa, Florida, United States, 33606
      • Acorda Site #201
    • Tampa, Florida, United States, 33609
      • Acorda Site #234
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Acorda Site #217
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Acorda Site #232
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Acorda Site #225
  • Iowa
    • Ames, Iowa, United States, 50010
      • Acorda Site #226
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Acorda Site #202
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Acorda Site #212
    • Boston, Massachusetts, United States, 02115
      • Acorda Site #214
    • Boston, Massachusetts, United States, 02215
      • Acorda Site #208
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Acorda Site #216
    • Saint Louis, Missouri, United States, 63131
      • Acorda Site #205
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Acorda Site #222
  • New York
    • New York, New York, United States, 10016
      • Acorda Site #223
    • Rochester, New York, United States, 14642
      • Acorda Site #233
  • Oregon
    • Portland, Oregon, United States, 97239
      • Acorda Site #230
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Acorda Site #219
    • Philadelphia, Pennsylvania, United States, 19107
      • Acorda Site #237
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Acorda Site #203
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Acorda Site #235
    • Nashville, Tennessee, United States, 37232
      • Acorda Site #218
  • Texas
    • Dallas, Texas, United States, 75251
      • Acorda Site #221
    • Houston, Texas, United States, 77030
      • Acorda Site #229
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Acorda Site #215
  • Washington
    • Renton, Washington, United States, 98057
      • Acorda Site #224
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Acorda Site #210

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 63 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: diazepam nasal spray
Experimental: 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.	Drug: diazepam nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Olfactory Changes as Measured by the Smell Identification Test (SIT)	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.	Screening, weeks 12, 24, 36, 48 and 51
Change From Baseline (Screening) in Nasal Mucosa.	Change from baseline treatment visits using a focused nasal exam was based on a scale of nasal irritation "none" to Grade 4 "septal perforation."	Screening, Weeks 12, 24, 36, 48 and 51
Change in Taste as Measured by a Taste Change Questionnaire	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).	Weeks 12, 24

Collaborators and Investigators

• Sponsor: Acorda Therapeutics
• Investigators: Study Director: MinJae Lee, SK Biopharmaceuticals Co, Ltd

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 15, 2014

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Seizures; Cluster Seizures; Clusters; Acute repetitive seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Diazepam
• Other Study ID Numbers: DZNS-EP-1025