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

Primary Purpose

Refractory Epilepsy

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
clobazam (Onfi)
Initial conversion and titration
Conversion schedule - Week 1
Conversion schedule - Week 2
Conversion schedule - Week 3
Sponsored by
St. Joseph's Hospital and Medical Center, Phoenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Epilepsy focused on measuring epilepsy, Onfi, clonazepam

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banner Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

clonazepam conversion to clobazam (Onfi)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tolerability
Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 6 weeks, 12 weeks, 24 weeks, and 52 weeks.
Retention
Retention rate of Onfi at 6-months and 12-months.

Full Information

First Posted
August 23, 2013
Last Updated
March 1, 2017
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Collaborators
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01932502
Brief Title
Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy
Official Title
Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy: Efficacy, Tolerability, Dosing Equivalence, and Retention Rate
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Collaborators
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: What should be the optimal equivalent doses for conversion? How quickly should it be converted? Would there be significant improvement of seizure control? Should we expect difference in tolerability? If so, what are common adverse events? Would the tolerance to the therapeutic effect differ with Onfi after conversion?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Epilepsy
Keywords
epilepsy, Onfi, clonazepam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
clonazepam conversion to clobazam (Onfi)
Arm Type
Experimental
Arm Description
Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control.
Intervention Type
Drug
Intervention Name(s)
clobazam (Onfi)
Intervention Description
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
Intervention Name(s)
Initial conversion and titration
Other Intervention Name(s)
clobazam (Onfi)
Intervention Description
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
Intervention Name(s)
Conversion schedule - Week 1
Other Intervention Name(s)
clobazam (Onfi)
Intervention Description
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
Intervention Name(s)
Conversion schedule - Week 2
Other Intervention Name(s)
clobazam (Onfi)
Intervention Description
Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold.
Intervention Type
Drug
Intervention Name(s)
Conversion schedule - Week 3
Other Intervention Name(s)
clobazam (Onfi)
Intervention Description
Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated.
Primary Outcome Measure Information:
Title
Efficacy
Description
Efficacy will be measured by percentage of mean seizure reduction averaged over 28 days.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Tolerability
Description
Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 6 weeks, 12 weeks, 24 weeks, and 52 weeks.
Time Frame
Weeks 6 - 52 after medication conversion
Title
Retention
Description
Retention rate of Onfi at 6-months and 12-months.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Chung, MD
Organizational Affiliation
Banner Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Health
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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