Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-21 @ 8:36 PM
Study NCT ID:
NCT01932502
Status:
UNKNOWN
Last Update Posted:
2017-03-03
First Post:
2013-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy
Sponsor:
St. Joseph's Hospital and Medical Center, Phoenix
Organization:
Study Overview
Official Title:
Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy: Efficacy, Tolerability, Dosing Equivalence, and Retention Rate
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to examine the clinical safety, tolerability, and efficacy of clobazam (Onfi) when it replaces the pre-existing clonazepam therapy in patients with refractory epilepsy.
Detailed Description:
The study is designed to answer frequently asked questions when clinicians replace existing 1,4-benzodiazepine to Onfi, as follows:
1. What should be the optimal equivalent doses for conversion?
2. How quickly should it be converted?
3. Would there be significant improvement of seizure control?
4. Should we expect difference in tolerability? If so, what are common adverse events?
5. Would the tolerance to the therapeutic effect differ with Onfi after conversion?
1. What should be the optimal equivalent doses for conversion?
2. How quickly should it be converted?
3. Would there be significant improvement of seizure control?
4. Should we expect difference in tolerability? If so, what are common adverse events?
5. Would the tolerance to the therapeutic effect differ with Onfi after conversion?
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: