An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
Stopped early · Phase 2
Conditions studied: Epilepsy
In brief
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).
Key facts
- Study ID
- NCT02316847
- Run by
- Acorda Therapeutics
- People needed
- 126
- Starts
- 2014-12-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2018-07-30
Who can join
Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 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
- Acorda Site #232 — Honolulu, Hawaii, United States
- Acorda Site #225 — Fort Wayne, Indiana, United States
- Acorda Site #226 — Ames, Iowa, United States
- Acorda Site #202 — Bethesda, Maryland, United States
- Acorda Site #212 — Boston, Massachusetts, United States
- Acorda Site #214 — Boston, Massachusetts, United States
- Acorda Site #208 — Boston, Massachusetts, United States
- Acorda Site #216 — Kansas City, Missouri, United States
- Acorda Site #205 — St Louis, Missouri, United States
- Acorda Site #222 — Hackensack, New Jersey, United States
- Acorda Site #223 — New York, New York, United States
- Acorda Site #233 — Rochester, New York, United States
- Acorda Site #230 — Portland, Oregon, United States
- Acorda Site #219 — Philadelphia, Pennsylvania, United States
- Acorda Site #237 — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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