Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
NCT00319501
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
For Patient:
- Older than 2 years of age and between 6 and 136 kg body weight
- Recipient of clinical diagnosis of epilepsy, taking a stable antiepileptic drug regimen for at least 2 weeks, and requiring intermittent medical intervention to control episodes of acute repetitive seizures (ARS)
- Experienced at least 2 episodes of ARS in previous year, one of which occurred in previous 6 months
- Has episodes of ARS that include complex partial or generalized seizures
- Has a responsible caregiver available to participate
- Is not pregnant or lactating and is practicing an acceptable method of birth control.
For Caregiver:
- Age of 18 years or older and has demonstrated responsibility as a caregiver through training to:
- Recognize an episode of repetitive seizures for which the injection was intended,
- Administer study drug
- Count and record seizures and respiratory rate in the patient diary,
- Monitor the patient and record observations in the patient diary for 12 hours following study drug treatment
- Recognize the need for immediate medical attention.
Key
For Patient:
- Petit mal status or petit mal variant status
- History of ARS consistently progressing to status epilepticus
- History of failure to respond to benzodiazepine treatment
- Hypersensitivity to diazepam
- Acute narrow angle glaucoma
- Alcohol and/or other substance abuse
- Has taken another investigational drug in previous 30 days
- Acute or progressive neurologic or severe psychiatric disease or severe mental
abnormality.
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Descriptive Information | ||||
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Brief Title ICMJE | Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures. | |||
Official Title ICMJE | A Phase 3, Randomized, Double-blind, Parallel, Placebo-controlled, Multicenter Study, With Optional Open-label Continuation, Of The Efficacy And Safety Of Vanquix(tm) Auto-injector (Diazepam Injection) For The Management Of Selected, Refractory, Patients With Epilepsy Who Require Intermittent Medical Intervention To Control Episodes Of Acute Repetitive Seizures | |||
Brief Summary | To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures. In addition, to assess the support provided by caregivers who are not themselves or not under the direct supervision of health care professionals at the time of administration. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Abou-Khalil B, Wheless J, Rogin J, Wolter KD, Pixton GC, Shukla RB, Sherman NA, Sommerville K, Goli V, Roland CL. A double-blind, randomized, placebo-controlled trial of a diazepam auto-injector administered by caregivers to patients with epilepsy who require intermittent intervention for acute repetitive seizures. Epilepsia. 2013 Nov;54(11):1968-76. doi: 10.1111/epi.12373. Epub 2013 Sep 20. Erratum in: Epilepsia. 2018 Dec;59(12):2344. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 234 | |||
Original Enrollment ICMJE | 325 | |||
Actual Study Completion Date ICMJE | July 2014 | |||
Actual Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Key Inclusion Criteria For Patient:
For Caregiver:
Key Exclusion Criteria For Patient:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 2 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00319501 | |||
Other Study ID Numbers ICMJE | K826-05-3001 B4511001 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |