NCT01932502

Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy

Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy: Efficacy, Tolerability, Dosing Equivalence, and Retention Rate

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Refractory Epilepsy

Interventions

Type	Name	Description
DRUG	clobazam (Onfi)	Subject's clonazepam will be converted to the following Onfi doses per day: Clonazepam 0.5mg converted to Onfi 10mg first week, then titrated up to 40mg per day. Clonazepam 1.0-2.0mg converted to Onfi 20mg first week, then titrated up to 40mg per day. Clonazepam 2-4mg converted to Onfi 20mg first week, then titrated up to 60mg per day. Initial conversion will occur over two weeks followed by upward titration of up to 10mg increment per week toward the target dose. Down titration of up to 10mg will be allowed during the study. The following will be the initial conversion schedule from clonazepam to Onfi: Week 1: 50% reduction of clonazepam and starting dose of Onfi, replacing the reduced clonazepam dose with the conversion rate of clonazepam 0.5mg = Onfi 10mg. Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold. Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated
DRUG	Initial conversion and titration	Initial conversion will occur over two weeks followed by upward titration of up to 10mg increment per week toward the target dose. Down titration of up to 10mg will be allowed during the study.
DRUG	Conversion schedule - Week 1	The following will be the initial conversion schedule from clonazepam to Onfi: Week 1: 50% reduction of clonazepam and starting dose of Onfi, replacing the reduced clonazepam dose with the conversion rate of clonazepam 0.5mg=Onfi 10mg.
DRUG	Conversion schedule - Week 2	Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold.
DRUG	Conversion schedule - Week 3	Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated.

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-06-01
• Completion: 2017-09-01
• First posted: 2013-08-30
• Last updated: 2017-03-03

Locations

1 site across 1 country: United States