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Benzodiazepine
Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy
Phase 4
Waitlist Available
Led By Steve Chung, MD
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 6 - 52 after medication conversion
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial tests if clobazam (Onfi) is safe and effective for patients with difficult-to-treat epilepsy when it replaces clonazepam. The study aims to find the best dose, speed of conversion, and whether it improves seizure control and tolerability. Clobazam has been used internationally for many years as a safe and well-tolerated additional treatment for various types of epilepsy, including difficult-to-treat epilepsy.
Eligible Conditions
- Epilepsy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 6 - 52 after medication conversion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 6 - 52 after medication conversion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy
Secondary study objectives
Retention
Tolerability
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
1Treatment groups
Experimental Treatment
Group I: clonazepam conversion to clobazam (Onfi)Experimental Treatment5 Interventions
Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control.
Find a Location
Who is running the clinical trial?
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
67 Previous Clinical Trials
17,343 Total Patients Enrolled
H. Lundbeck A/SIndustry Sponsor
331 Previous Clinical Trials
78,186 Total Patients Enrolled
3 Trials studying Epilepsy
221 Patients Enrolled for Epilepsy
Steve Chung, MDPrincipal InvestigatorBanner Health Systems