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

NCT01932502 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-03-03

No results posted yet for this study

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

Interventions

DRUG

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

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.

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.

DRUG

Conversion schedule - Week 2

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

DRUG

Conversion schedule - Week 3

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

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • Steve Chung, MD · Banner Health Systems

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2017-06-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01932502 on ClinicalTrials.gov