Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures - Tabular View

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

This study is currently recruiting participants.

Study NCT00594945. Last updated on September 16, 2008. Information provided by Jazz Pharmaceuticals

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
Official 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
Brief Summary	Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
Detailed Description
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Open Label, Uncontrolled, Single Group Assignment
Primary Outcome Measure ^†	EEG [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
Secondary Outcome Measure ^†	Safety [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]
Condition ^†	Epilepsy
Intervention ^†	Drug: Clonazepam
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Recruiting
Enrollment ^†	45
Start Date ^†	December 2007
Completion Date
Eligibility Criteria ^†	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Finland

Administrative Information Fields
NCT ID ^†	NCT00594945
Organization ID	07-001
Secondary IDs ^††
Study Sponsor ^†	Jazz Pharmaceuticals
Collaborators ^††
Investigators ^†
Information Provided By	Jazz Pharmaceuticals
Verification Date	September 2008
First Received Date ^†	January 7, 2008
Last Updated Date	September 16, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.