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

Status unconfirmed · Phase 4

Conditions studied: Refractory Epilepsy

In brief

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.

Key facts

Study ID

NCT01932502

Run by

St. Joseph's Hospital and Medical Center, Phoenix

People needed

21

Starts

2013-02-01

Expected to finish

2017-09-01

Last updated by the study team

2017-03-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Banner Health — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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