Study Stopped
Recruitment Issues - Lack of target population
Clobazam Use in Epilepsia Partialis Continua - Pilot Study
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
1 other identifier
interventional
7
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2014
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedMay 9, 2018
May 1, 2018
3 years
May 6, 2014
May 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time (measured in minutes) to onset of seizure freedom
Within 7 days
Reduction of seizure frequency/minute
Within 7 days
Secondary Outcomes (2)
Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale
Within 37 days
Ambulatory function as measured by the Hauser Ambulation Index
Within 37 days
Study Arms (3)
Clobazam
EXPERIMENTALSubjects 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 COMPARATORSubjects 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 COMPARATORSubjects 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.
Interventions
Comparison of AED use in Epilepsia Partialis Continua
Comparison of AED use in Epilepsia Partialis Continua
Comparison of AED use in Epilepsia Partialis Continua
Eligibility Criteria
You may qualify if:
- ≥ to 18 yrs of age
- Diagnosis of EPC by a Neurologist
You may not qualify if:
- 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
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Cooper Health Systemlead
- Lundbeck LLCcollaborator
Study Sites (1)
Cooper Universtiy Hospital
Camden, New Jersey, 08103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Carran, MD
Cooper University Health System
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2014
First Posted
May 9, 2014
Study Start
July 1, 2014
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
May 9, 2018
Record last verified: 2018-05