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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

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.

Condition or disease Intervention/treatment Phase
Refractory Epilepsy Drug: clobazam (Onfi) Drug: Initial conversion and titration Drug: Conversion schedule - Week 1 Drug: Conversion schedule - Week 2 Drug: Conversion schedule - Week 3 Phase 4

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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy: Efficacy, Tolerability, Dosing Equivalence, and Retention Rate
Study Start Date : February 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: clonazepam conversion to clobazam (Onfi)
Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control.
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)




Primary Outcome Measures :
  1. Efficacy [ Time Frame: 28 days ]
    Efficacy will be measured by percentage of mean seizure reduction averaged over 28 days.


Secondary Outcome Measures :
  1. 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.

  2. Retention [ Time Frame: 52 weeks ]
    Retention rate of Onfi at 6-months and 12-months.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932502


Locations
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United States, Arizona
Banner Health
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
H. Lundbeck A/S
Investigators
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Principal Investigator: Steve Chung, MD Banner Health Systems
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Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT01932502    
Other Study ID Numbers: 13BN001
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
epilepsy
Onfi
clonazepam
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Clobazam
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action