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

NCT02316847 | Terminated Phase 2 Results DMC

• 1 other identifier: DZNS-EP-1025
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 33

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).

Conditions

Epilepsy

Keywords

Cluster Seizures; Seizures; Clusters; Acute repetitive seizures

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

diazepam nasal spray (Adults)

EXPERIMENTAL

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

Diazepam Nasal Spray (Adolescents)

EXPERIMENTAL

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

Interventions

diazepam nasal spray DRUG

Diazepam Nasal Spray (Adolescents); diazepam nasal spray (Adults)

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acorda Therapeutics: lead

Study Sites (33)

Acorda Site #227

Phoenix, Arizona, 85054, United States

Location

Acorda Site #204

Little Rock, Arkansas, 72205, United States

Location

Acorda Site #213

Los Angeles, California, 90095, United States

Location

Acorda Site #220

Orange, California, 92868, United States

Location

Acorda Site #206

Orlando, Florida, 32819, United States

Location

Acorda Site #241

Port Charlotte, Florida, 33592, United States

Location

Acorda Site #231

Tallahassee, Florida, 32308, United States

Location

Acorda Site #201

Tampa, Florida, 33606, United States

Location

Acorda Site #234

Tampa, Florida, 33609, United States

Location

Acorda Site #217

Augusta, Georgia, 30912, United States

Location

Acorda Site #232

Honolulu, Hawaii, 96817, United States

Location

Acorda Site #225

Fort Wayne, Indiana, 46804, United States

Location

Acorda Site #226

Ames, Iowa, 50010, United States

Location

Acorda Site #202

Bethesda, Maryland, 20817, United States

Location

Acorda Site #212

Boston, Massachusetts, 02115, United States

Location

Acorda Site #214

Boston, Massachusetts, 02115, United States

Location

Acorda Site #208

Boston, Massachusetts, 02215, United States

Location

Acorda Site #216

Kansas City, Missouri, 64111, United States

Location

Acorda Site #205

St Louis, Missouri, 63131, United States

Location

Acorda Site #222

Hackensack, New Jersey, 07601, United States

Location

Acorda Site #223

New York, New York, 10016, United States

Location

Acorda Site #233

Rochester, New York, 14642, United States

Location

Acorda Site #230

Portland, Oregon, 97239, United States

Location

Acorda Site #219

Philadelphia, Pennsylvania, 19104, United States

Location

Acorda Site #237

Philadelphia, Pennsylvania, 19107, United States

Location

Acorda Site #203

Charleston, South Carolina, 29425, United States

Location

Acorda Site #235

Memphis, Tennessee, 38103, United States

Location

Acorda Site #218

Nashville, Tennessee, 37232, United States

Location

Acorda Site #221

Dallas, Texas, 75251, United States

Location

Acorda Site #229

Houston, Texas, 77030, United States

Location

Acorda Site #215

Richmond, Virginia, 23298, United States

Location

Acorda Site #224

Renton, Washington, 98057, United States

Location

Acorda Site #210

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: MinJae Lee, Associate Manager
• Organization: SK Bio-pharmaceuticals Co, Ltd

minj.lee@sk.com

Study Officials

• MinJae Lee

  SK Biopharmaceuticals Co, Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 15, 2014
• Study Start: December 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 30, 2018
• Results First Posted: July 30, 2018

Record last verified: 2018-07

Locations

US (33)