Trial record 11 of 42 for:    acorda

A Study to Determine the Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Acorda Therapeutics
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT02474407
First received: June 15, 2015
Last updated: June 29, 2015
Last verified: June 2015
  Purpose

This is a multi-center, open-label, crossover, pharmacokinetic, bioavailability study involving adolescents and adults with refractory (drug-resistant) epilepsy


Condition Intervention Phase
Refractory Epilepsy
Drug: diazepam nasal spray
Drug: diazepam rectal gel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Crossover Pharmacokinetic Study to Determine the Bioavailability, Safety and Tolerability of Single Doses of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®) in Patients With Refractory Epilepsy

Resource links provided by NLM:


Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Maximum measured plasma concentration (Cmax) [ Time Frame: baseline, up to 24 hours post-dose ] [ Designated as safety issue: No ]
  • Time to maximum measured plasma concentration (tmax) [ Time Frame: baseline, up to 24 hours post-dose ] [ Designated as safety issue: No ]
  • Area under the concentration curve (AUC) values [ Time Frame: baseline, up to 24 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Focused nasal exam [ Time Frame: pre-dose (day 1) up to 24 hours post-dose (up to day 31) ] [ Designated as safety issue: Yes ]
  • Smell Identification Test (SIT) [ Time Frame: day 1 up to day 31 ] [ Designated as safety issue: Yes ]
  • Taste change questionnaire [ Time Frame: up to 24 hours post-dose ] [ Designated as safety issue: Yes ]
  • Number of participants with serious and non-serious adverse events [ Time Frame: up to 33 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 122
Study Start Date: June 2015
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: diazepam nasal spray/diazepam rectal gel

One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.

A single rectal dose of diazepam will be administered to subjects according to the Diastat prescribing information.

Drug: diazepam nasal spray
Other Name: Diazepam
Drug: diazepam rectal gel
Other Names:
  • Diastat®
  • AcuDial™

Detailed Description:

To determine the bioavailability of diazepam nasal spray versus diazepam rectal gel (Diastat®) under conditions of use in adolescent and adult persons with epilepsy (PWE) meeting the definition of refractory epilepsy.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02474407

Locations
United States, Florida
Acorda Site #101 Recruiting
Tampa, Florida, United States, 33606
Contact: Tara McTigue    813-259-0826      
United States, Maryland
Acorda Site #102 Recruiting
Bethesda, Maryland, United States, 20817
Contact: Arkady Barber    301-530-9744      
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: David Squillacote, MD Acorda Therapeutics
  More Information

No publications provided

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02474407     History of Changes
Other Study ID Numbers: DZNS-EP-1019
Study First Received: June 15, 2015
Last Updated: June 29, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:
Seizures
Epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Diazepam
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Anticonvulsants
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Gastrointestinal Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Muscle Relaxants, Central
Neuromuscular Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on August 27, 2015