Epilepsia Partialis ContinuaPhase 3NCT02134366
Clobazam Use in Epilepsia Partialis Continua - Pilot Study
A Phase 3 study testing Clobazam, Clonazepam and Lorazepam in people with Epilepsia Partialis Continua and Kojewnikov's Epilepsy, run by The Cooper Health System at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether clobazam, brand name Onf®, is more effective as an adjunctive or monotherapy in terminating Epilepsia Partialis Continua (EPC) than either lorazepam and/or clonazepam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsia Partialis Continua, Kojewnikov's Epilepsy, Epilepsy
- What is being tested?
- Clobazam, Clonazepam and Lorazepam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2017
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •≥ to 18 yrs of age
- •Diagnosis of EPC by a Neurologist
Who cannot join
- Previous exposure to clobazam prior to presentation
- Seizure generalization
- Patients who are intubated and on IV sedation such as Versed®, Propofol or Presedex®.
- Female subjects who are pregnant and/or breast-feeding
- Subject has an unstable and/or serious or psychiatric illness
- Subject has an unstable and/or serious medical illness
Show all 28Show fewer
- Subject has any of the following but not limited to conditions:
- A life threatening medical condition
- Severe sepsis or septic shock
- Severe Renal impairment
- Severe Hepatic impairment
- Sleep apnea
- Narrow angle glaucoma
- Severe respiratory insufficiency
- Myasthenia gravis
- Metastatic cancer
- Organ failure
- Severe progressive nervous system disease
- A clinically significant EKG abnormality that would be affected by and/or affect the patient's participation in the trial
- Subject has active suicidal ideation at Screening and Baseline visits
- Subject has a history of suicidal thoughts or behaviors, which would be indicated by a positive response to questions 4 and/or 5 on the CSSR-S. Exclusionary actions include but are not limited to:
- Previous intent to act on suicidal ideation with a specific plan
- Previous preparatory acts or behavior
- A previous actual attempt, interrupted attempt or aborted suicide attempt
- Subject has a history of alcohol and/or substance abuse in the previous 12 months, or the subject is unable to refrain from alcohol and/or substance abuse during the study.
- Subject admits to present illicit drug use or has a positive drug screen
- Subject is currently enrolled in or has been enrolled in any clinical trial within the past 30 days
- Subject has a known allergy to any component of the study medication(s)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper Universtiy Hospital
Camden, New Jersey, 08103
About this study
Official title: A Phase III, Randomized, Open Label, Single Center, Study on the Effects of Treatment of Epilepsia Partialis Continua With Clobazam Compared to Treatment With or in Addition to Lorazepam and/or Clonazepam
The purpose of this study is to evaluate whether clobazam, brand name Onf®, is more effective as an adjunctive or monotherapy in terminating Epilepsia Partialis Continua (EPC) than either lorazepam and/or clonazepam.
Read the detailed description
First approved in the United States in 2011 for use in treating Lennox-Gastaut syndrome, clobazam is the only 1, 5-benzodiazepine that is currently approved for clinical use in the United States. In previous clinical trials clobazam has been shown to have a greater efficacy and produce fewer side effects in individuals when it's adverse event profile is compared to the traditional 1,4-benzodiazepines such as diazepam, lorazepam, and clonazepam. As a benzodiazepine, clobazam has been found to have anticonvulsant properties, and structural differences as a 1,5-benzodiazepines that appear to have a broader spectrum of anticonvulsant activity than those found in 1,4-benzodiazepines. In previous reports, clobazam has been seen to be effective in ether terminating or reducing both EPC in particular and partial status epilepticus.
- Being tested
- Clobazam, Clonazepam, Lorazepam
- Keywords
- Epilepsia Partialis Continua, Kojewnikov's Epilepsy, Epilepsy, Clobazam, Focal Motor Epilepsy, Partial Motor Seizure
- Medical subject headings
- Epilepsia Partialis Continua, Epilepsy, Epilepsy, Partial, Motor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClobazamDrug
Also called Onfi, Frisium, Urbanol
Comparison of AED use in Epilepsia Partialis Continua
ClonazepamDrug
Also called Klonopin
Comparison of AED use in Epilepsia Partialis Continua
LorazepamDrug
Also called Ativan, Orfidal
Comparison of AED use in Epilepsia Partialis Continua
| Study group | Role | What they receive |
|---|---|---|
| Clobazam | Experimental | Subjects who are assigned the clobazam treatment group will receive a 10mg loading dose followed by a maintenance dose of 5-25 mg bid starting 12 hrs after the loading dose. If subjects are found to have failed to respond to treatment with clobazam, the physician investigator has the ability to either start another AED or increase the dose of clobazam depending on the clinical situation. Subjects still being treated with clobazam at discharge will be given a 30 day supply of clobazam. Receives: Drug: Clobazam; Drug: Clonazepam; Drug: Lorazepam |
| Clonazepam | Active comparator | Subjects who are assigned to the clonazepam treatment group will receive a dose of 1-2mg clonazepam dose tid. Following the initial treatment if a physician investigator determines that the subject's treatment has failed, the investigator has the option of treating the subject with clobazam at which point the individuals would be treated in the same method as those originally assigned to the clobazam treatment group. Receives: Drug: Clobazam; Drug: Clonazepam; Drug: Lorazepam |
| Lorazepam | Active comparator | Subjects who are assigned to the lorazepam treatment group will receive a 1-2mg dose of lorazepam qid. Following the initial treatment if a physician investigator determines that the subject's treatment has failed, the investigator has the option of treating the subject with clobazam at which point the individuals would be treated in the same method as those originally assigned to the clobazam treatment group. Receives: Drug: Clobazam; Drug: Clonazepam; Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (measured in minutes) to onset of seizure freedom
Measured: Within 7 days
Reduction of seizure frequency/minute
Measured: Within 7 days
Secondary outcomes (2)
Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale
Measured: Within 37 days
Ambulatory function as measured by the Hauser Ambulation Index
Measured: Within 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: Recruitment Issues - Lack of target population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsia Partialis ContinuaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cooper Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck LLC
- Responsible party
- Sponsor
- Investigators
- Melissa Carran, MD, Principal investigator, Cooper University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134366
- Sponsor's protocol ID
- EPC-1
- Status last verified
- May 2018
- First submitted
- 6 May 2014
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open Label, Single Center, Study on the Effects of Treatment of Epilepsia Partialis Continua With Clobazam Compared to Treatment With or in Addition to Lorazepam and/or Clonazepam
- ClinicalTrials.gov ID
- NCT02134366
- Acronym / sponsor ID
- EPC-1
- Keywords
- Epilepsia Partialis Continua, Kojewnikov's Epilepsy, Epilepsy, Clobazam, Focal Motor Epilepsy, Partial Motor Seizure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment Issues - Lack of target population
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Collaborators
- Lundbeck LLC
- Study start
- Jul 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 May 2014 (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 this study is to evaluate whether clobazam, brand name Onf®, is more effective as an adjunctive or monotherapy in terminating Epilepsia Partialis Continua (EPC) than either lorazepam and/or clonazepam.
Detailed description
First approved in the United States in 2011 for use in treating Lennox-Gastaut syndrome, clobazam is the only 1, 5-benzodiazepine that is currently approved for clinical use in the United States. In previous clinical trials clobazam has been shown to have a greater efficacy and produce fewer side effects in individuals when it's adverse event profile is compared to the traditional 1,4-benzodiazepines such as diazepam, lorazepam, and clonazepam. As a benzodiazepine, clobazam has been found to have anticonvulsant properties, and structural differences as a 1,5-benzodiazepines that appear to have a broader spectrum of anticonvulsant activity than those found in 1,4-benzodiazepines. In previous reports, clobazam has been seen to be effective in ether terminating or reducing both EPC in particular and partial status epilepticus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clobazam | Experimental | Drug: Clobazam, Drug: Clonazepam, Drug: LorazepamSubjects who are assigned the clobazam treatment group will receive a 10mg loading dose followed by a maintenance dose of 5-25 mg bid starting 12 hrs after the loading dose. If subjects are found to have failed to respond to treatment with clobazam, the physician investigator has the ability to either start another AED or increase the dose of clobazam depending on the clinical situation. Subjects still being treated with clobazam at discharge will be given a 30 day supply of clobazam. |
| Clonazepam | Active comparator | Drug: Clobazam, Drug: Clonazepam, Drug: LorazepamSubjects who are assigned to the clonazepam treatment group will receive a dose of 1-2mg clonazepam dose tid. Following the initial treatment if a physician investigator determines that the subject's treatment has failed, the investigator has the option of treating the subject with clobazam at which point the individuals would be treated in the same method as those originally assigned to the clobazam treatment group. |
| Lorazepam | Active comparator | Drug: Clobazam, Drug: Clonazepam, Drug: LorazepamSubjects who are assigned to the lorazepam treatment group will receive a 1-2mg dose of lorazepam qid. Following the initial treatment if a physician investigator determines that the subject's treatment has failed, the investigator has the option of treating the subject with clobazam at which point the individuals would be treated in the same method as those originally assigned to the clobazam treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- •≥ to 18 yrs of age
- •Diagnosis of EPC by a Neurologist
Key exclusion criteria (28 listed)
- Previous exposure to clobazam prior to presentation
- Seizure generalization
- Patients who are intubated and on IV sedation such as Versed®, Propofol or Presedex®.
- Female subjects who are pregnant and/or breast-feeding
- Subject has an unstable and/or serious or psychiatric illness
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 |
|---|---|---|
| ClobazamAlso: Onfi, Frisium, UrbanolComparison of AED use in Epilepsia Partialis Continua | Drug | Clobazam, Clonazepam, Lorazepam |
| ClonazepamAlso: KlonopinComparison of AED use in Epilepsia Partialis Continua | Drug | Clobazam, Clonazepam, Lorazepam |
| LorazepamAlso: Ativan, OrfidalComparison of AED use in Epilepsia Partialis Continua | Drug | Clobazam, Clonazepam, Lorazepam |
Primary outcome
Time (measured in minutes) to onset of seizure freedom
Time frame: Within 7 days
Reduction of seizure frequency/minute
Time frame: Within 7 days
2 secondary outcomes
Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale
Time frame: Within 37 days
Ambulatory function as measured by the Hauser Ambulation Index
Time frame: Within 37 days
Results and safety
The study was stopped early (reason given: Recruitment Issues - Lack of target population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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.
Melissa Carran, MD principal investigator
Cooper University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clobazam, Clonazepam and Lorazepam in people with Epilepsia Partialis Continua and Kojewnikov's Epilepsy, run by The Cooper Health System 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 2 inclusion and 28 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: stopped early, as of the sponsor's last update on 9 May 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment Issues - Lack of target population). 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?
Time (measured in minutes) to onset of seizure freedom (time frame: Within 7 days). The study lists 2 primary outcomes in all. 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 9 May 2018; AzTrials last refreshed its copy on 27 Oct 2026.