Clobazam Use in Epilepsia Partialis Continua - Pilot Study (NCT02134366) | Clinical Trial Compass
TerminatedPhase 3
Clobazam Use in Epilepsia Partialis Continua - Pilot Study
Stopped: Recruitment Issues - Lack of target population
United States7 participantsStarted 2014-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
•≥ to 18 yrs of age
•Diagnosis of EPC by a Neurologist
Exclusion Criteria:
* 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
* 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 month…
What they're measuring
1
Time (measured in minutes) to onset of seizure freedom