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

Epilepsy Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02316847
• Other study ID #: DZNS-EP-1025
• Status: Terminated
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: September 2016

Study information

• Verified date: July 2018
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• diazepam nasal spray

Locations

Country	Name	City	State
United States	Acorda Site #226	Ames	Iowa
United States	Acorda Site #217	Augusta	Georgia
United States	Acorda Site #202	Bethesda	Maryland
United States	Acorda Site #208	Boston	Massachusetts
United States	Acorda Site #212	Boston	Massachusetts
United States	Acorda Site #214	Boston	Massachusetts
United States	Acorda Site #203	Charleston	South Carolina
United States	Acorda Site #221	Dallas	Texas
United States	Acorda Site #225	Fort Wayne	Indiana
United States	Acorda Site #222	Hackensack	New Jersey
United States	Acorda Site #232	Honolulu	Hawaii
United States	Acorda Site #229	Houston	Texas
United States	Acorda Site #216	Kansas City	Missouri
United States	Acorda Site #204	Little Rock	Arkansas
United States	Acorda Site #213	Los Angeles	California
United States	Acorda Site #210	Madison	Wisconsin
United States	Acorda Site #235	Memphis	Tennessee
United States	Acorda Site #218	Nashville	Tennessee
United States	Acorda Site #223	New York	New York
United States	Acorda Site #220	Orange	California
United States	Acorda Site #206	Orlando	Florida
United States	Acorda Site #219	Philadelphia	Pennsylvania
United States	Acorda Site #237	Philadelphia	Pennsylvania
United States	Acorda Site #227	Phoenix	Arizona
United States	Acorda Site #241	Port Charlotte	Florida
United States	Acorda Site #230	Portland	Oregon
United States	Acorda Site #224	Renton	Washington
United States	Acorda Site #215	Richmond	Virginia
United States	Acorda Site #233	Rochester	New York
United States	Acorda Site #205	Saint Louis	Missouri
United States	Acorda Site #231	Tallahassee	Florida
United States	Acorda Site #201	Tampa	Florida
United States	Acorda Site #234	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   Click here for potential enrollment or for more information about this study: DZNS-EP-1025