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

NCT ID: NCT01932502

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-09-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

clonazepam conversion to clobazam (Onfi)

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

Group Type: EXPERIMENTAL

clobazam (Onfi)

Intervention Type: 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

Initial conversion and titration

Intervention Type: 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.

Conversion schedule - Week 1

Intervention Type: 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.

Conversion schedule - Week 2

Intervention Type: DRUG

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

Conversion schedule - Week 3

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Conversion schedule - Week 2

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

Intervention Type: DRUG

Conversion schedule - Week 3

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

Intervention Type: DRUG

Other Intervention Names

clobazam (Onfi); clobazam (Onfi); clobazam (Onfi); clobazam (Onfi)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

St. Joseph's Hospital and Medical Center, Phoenix

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Banner Health Systems

Locations

Banner Health

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

13BN001

Identifier Type: -

Identifier Source: org_study_id