Refractory EpilepsyPhase 4NCT01932502
Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy
A Phase 4 study testing clobazam (Onfi), Initial conversion and titration and Conversion schedule - Week 1 in people with Refractory Epilepsy, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- clobazam (Onfi), Initial conversion and titration and Conversion schedule - Week 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy: Efficacy, Tolerability, Dosing Equivalence, and Retention Rate
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.
Read the 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?
- Conditions
- Refractory Epilepsy
- Being tested
- clobazam (Onfi), Initial conversion and titration, Conversion schedule - Week 1, Conversion schedule - Week 2, Conversion schedule - Week 3
- Keywords
- epilepsy, Onfi, clonazepam
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clobazam (Onfi)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 titrationDrug
Also called clobazam (Onfi)
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 1Drug
Also called clobazam (Onfi)
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 2Drug
Also called clobazam (Onfi)
Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold.
Conversion schedule - Week 3Drug
Also called clobazam (Onfi)
Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated.
| Study group | Role | What they receive |
|---|---|---|
| clonazepam conversion to clobazam (Onfi) | Experimental | Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control. Receives: Drug: clobazam (Onfi); Drug: Initial conversion and titration; Drug: Conversion schedule - Week 1; Drug: Conversion schedule - Week 2; Drug: Conversion schedule - Week 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Efficacy will be measured by percentage of mean seizure reduction averaged over 28 days.
Measured: 28 days
Secondary outcomes (2)
Tolerability
Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 6 weeks, 12 weeks, 24 weeks, and 52 weeks.
Measured: Weeks 6 - 52 after medication conversion
Retention
Retention rate of Onfi at 6-months and 12-months.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Sponsor
- Investigators
- Steve Chung, MD, Principal investigator, Banner Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932502
- Sponsor's protocol ID
- 13BN001
- Status last verified
- Mar 2017
- First submitted
- 23 Aug 2013
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy: Efficacy, Tolerability, Dosing Equivalence, and Retention Rate
- ClinicalTrials.gov ID
- NCT01932502
- Acronym / sponsor ID
- 13BN001
- Conditions
- Refractory Epilepsy
- Keywords
- epilepsy, Onfi, clonazepam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Feb 2013
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clonazepam conversion to clobazam (Onfi) | Experimental | Drug: clobazam (Onfi), Drug: Initial conversion and titration, Drug: Conversion schedule - Week 1, Drug: Conversion schedule - Week 2, Drug: Conversion schedule - Week 3Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | clonazepam conversion to clobazam (Onfi) |
| Initial conversion and titrationAlso: clobazam (Onfi)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 | clonazepam conversion to clobazam (Onfi) |
| Conversion schedule - Week 1Also: clobazam (Onfi)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 | clonazepam conversion to clobazam (Onfi) |
| Conversion schedule - Week 2Also: clobazam (Onfi)Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold. | Drug | clonazepam conversion to clobazam (Onfi) |
| Conversion schedule - Week 3Also: clobazam (Onfi)Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated. | Drug | clonazepam conversion to clobazam (Onfi) |
Primary outcome
Efficacy
Time frame: 28 days
Efficacy will be measured by percentage of mean seizure reduction averaged over 28 days.
2 secondary outcomes
Tolerability
Time frame: Weeks 6 - 52 after medication conversion
Retention
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Chung, MD principal investigator
Banner Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clobazam (Onfi), Initial conversion and titration and Conversion schedule - Week 1 in people with Refractory Epilepsy, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.