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

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Collaborator: H. Lundbeck A/S
• Treatments: Clobazam; Clonazepam

Criteria

Inclusion Criteria:

• Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to the initial study visit.

• Currently taking stable dosing regimen of clonazepam (0.5-4mg daily) for seizure control.

• Takes at least one additional Anti-epileptic drug besides benzodiazepine.

• Age 18-70 years, inclusive.

• In opinion of investigator, can be safely treated with Onfi.

• Minimum of 2 seizures, but no more than 24 complex partial or generalized seizures, during the 8-week baseline period prior to study entry.

• Able to communicate effectively with study personnel and considered reliable, able, willing, and cooperative with regard to complying with protocol-defined requirements, including completion of study diary.

Exclusion Criteria:

• Clinically relevant current illness or history of that may interfere with the subject's ability to complete the study as determined by the investigator.

• History of status epilepticus within 6 months prior to the initial study visit.

• History of suicidal attempts or suicidal ideation within 12 months of initial visit.