Skip to main content
OpenTrials
Completed

NCT Number: NCT00594945

Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tampere University Hospital, Tampere, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of refractory epilepsy
  • No Nasal conditions that would preclude the use of intranasal product

Exclusion criteria

  • Subject with a clinical significant unstable medical abnormality
  • Subject currently or regularly taking Clonazepam

Treatment and study plan

Clonazepam

Drug

1 Dose

Primary outcomes

  1. Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).

    Time frame: Change from baseline to treatment day

    Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2a, Open-label,Proof -Of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jan 16, 2008
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.