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

NCT01932502 | Unknown Phase 4 DMC

• 1 other identifier: 13BN001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Epilepsy

Keywords

epilepsy; Onfi; clonazepam

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Efficacy will be measured by percentage of mean seizure reduction averaged over 28 days.

  28 days

Secondary Outcomes (2)

• Tolerability

  Weeks 6 - 52 after medication conversion

• Retention

  52 weeks

Study Arms (1)

clonazepam conversion to clobazam (Onfi)

EXPERIMENTAL

Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control.

Drug: clobazam (Onfi); Drug: Initial conversion and titration; Drug: Conversion schedule - Week 1; Drug: Conversion schedule - Week 2; Drug: Conversion schedule - Week 3

Interventions

clobazam (Onfi) DRUG

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

clonazepam conversion to clobazam (Onfi)

Initial conversion and titration DRUG

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.

Also known as: clobazam (Onfi)

clonazepam conversion to clobazam (Onfi)

Conversion schedule - Week 1 DRUG

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.

Also known as: clobazam (Onfi)

clonazepam conversion to clobazam (Onfi)

Conversion schedule - Week 2 DRUG

Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold.

Also known as: clobazam (Onfi)

clonazepam conversion to clobazam (Onfi)

Conversion schedule - Week 3 DRUG

Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated.

Also known as: clobazam (Onfi)

clonazepam conversion to clobazam (Onfi)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

Banner Health

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy

Interventions

Clobazam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Steve Chung, MD

  Banner Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 30, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

US (1)