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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01932502
Recruitment Status : Unknown
Verified March 2017 by St. Joseph's Hospital and Medical Center, Phoenix.
Recruitment status was:  Active, not recruiting
First Posted : August 30, 2013
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Tracking Information
First Submitted Date  ICMJE August 23, 2013
First Posted Date  ICMJE August 30, 2013
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
Efficacy [ Time Frame: 28 days ]
Efficacy will be measured by percentage of mean seizure reduction averaged over 28 days.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
  • Tolerability [ Time Frame: Weeks 6 - 52 after medication conversion ]
    Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 6 weeks, 12 weeks, 24 weeks, and 52 weeks.
  • Retention [ Time Frame: 52 weeks ]
    Retention rate of Onfi at 6-months and 12-months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy
Official Title  ICMJE Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy: Efficacy, Tolerability, Dosing Equivalence, and Retention Rate
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?
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Refractory Epilepsy
Intervention  ICMJE
  • 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.
    Other Name: clobazam (Onfi)
  • 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.

    Other Name: clobazam (Onfi)
  • Drug: Conversion schedule - Week 2
    Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold.
    Other Name: clobazam (Onfi)
  • Drug: Conversion schedule - Week 3
    Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated.
    Other Name: clobazam (Onfi)
Study Arms  ICMJE Experimental: clonazepam conversion to clobazam (Onfi)
Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control.
Interventions:
  • Drug: clobazam (Onfi)
  • Drug: Initial conversion and titration
  • Drug: Conversion schedule - Week 1
  • Drug: Conversion schedule - Week 2
  • Drug: Conversion schedule - Week 3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 27, 2013)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01932502
Other Study ID Numbers  ICMJE 13BN001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Joseph's Hospital and Medical Center, Phoenix
Study Sponsor  ICMJE St. Joseph's Hospital and Medical Center, Phoenix
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE
Principal Investigator: Steve Chung, MD Banner Health Systems
PRS Account St. Joseph's Hospital and Medical Center, Phoenix
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP