Phase 3
N=234
Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
Seizures · Epilepsies, Partial · Epilepsy, Complex Partial · Epilepsy, Generalized · Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00319501 ↗Enrolled (actual)
234
Serious AEs
11.2%
Results posted
Aug 2016
Primary outcome: Primary: Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile) — 5.92; NA Hours — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Vanquix Auto-Injector (Diazepam Injection) (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile) |
5.92; NA | 0.012 sig |
| PRIMARY Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period |
22.4 | — |
| SECONDARY Number of Participants Requiring Rescue Medication During the Double-blind Period |
14; 24 | 0.066 |
| SECONDARY Number of Participants Requiring Emergency Department Visits During the Double-blind Period |
2; 4 | 0.443 |
| SECONDARY Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period |
0; 2 | 0.245 |
| SECONDARY Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period |
6.2; 5.5 | 0.086 |
| SECONDARY Mean Score on Physician Global Treatment Assessment During the Double-blind Period |
6.3; 5.5 | 0.045 sig |
| SECONDARY Number of Participants Requiring Rescue Medication During the Open-label Period |
39 | — |
| SECONDARY Number of Participants Requiring Emergency Department Visits During the Open-label Period |
13 | — |
| SECONDARY Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period |
5 | — |
| SECONDARY Mean Score on Caregiver Global Treatment Assessment During the Open-label Period |
6.78 | — |
| SECONDARY Mean Score on Physician Global Treatment Assessment During the Open-label Period |
6.87 | — |
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.
Eligibility Criteria
Key Inclusion Criteria
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 Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00319501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.