Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)

Stopped early · Phase 2

Conditions studied: Refractory Epilepsy

In brief

This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy. Cohort 1 comprises the subjects used to determine the relative bioavailability of DZNS versus DRG (Diastat)

Key facts

Study ID

NCT02474407

Run by

Acorda Therapeutics

People needed

78

Starts

2015-06-01

Expected to finish

2016-07-01

Last updated by the study team

2018-10-16

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of refractory epilepsy
• Body weight 26 to 111 kilogram (kg) inclusive
• Other inclusion criteria apply

You may not qualify if…

• Male or female subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product
• 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
• Other exclusion criteria apply

Where it is running

• Acorda Site #115 — Little Rock, Arkansas, United States
• Acorda Site #127 — Washington D.C., District of Columbia, United States
• Acorda Site #101 — Tampa, Florida, United States
• Acorda Site #125 — Honolulu, Hawaii, United States
• Acorda Site #104 — Lexington, Kentucky, United States
• Acorda Site #111 — Baltimore, Maryland, United States
• Acorda Site #102 — Bethesda, Maryland, United States
• Acorda Site #110 — Ann Arbor, Michigan, United States
• Acorda Site #117 — Jackson, Mississippi, United States
• Acorda Site #112 — St Louis, Missouri, United States
• Acorda Site #128 — Edison, New Jersey, United States
• Acorda Site #121 — Hackensack, New Jersey, United States
• Acorda Site #123 — Amherst, New York, United States
• Acorda Site #119 — Rochester, New York, United States
• Acorda Site #132 — Chapel Hill, North Carolina, United States
• Acorda Site #114 — Portland, Oregon, United States
• Acorda Site #116 — Philadelphia, Pennsylvania, United States
• Acorda Site #105 — Philadelphia, Pennsylvania, United States
• Acorda Site #130 — Memphis, Tennessee, United States
• Acorda Site #103 — Bellaire, Texas, United States
• Acorda Site #122 — Dallas, Texas, United States
• Acorda Site #108 — Houston, Texas, United States

Full record on ClinicalTrials.gov

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