Trial · NCT00319501
Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
NCT00319501, Phase 3, Completed, Pfizer; results first posted 2016-08-16
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ConductScience Library. Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures. Trials, record NCT00319501. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00319501
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
- NCT number
- NCT00319501
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 234 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Seizures, Epilepsies, Partial, Epilepsy, Complex Partial, Epilepsy, Generalized, Epilepsy
- Interventions
- Placebo, Vanquix Auto-Injector (Diazepam Injection)
- First posted
- 2006-04-27
- Last updated
- 2016-09-23
- Results first posted
- 2016-08-16
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile) | From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period | An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug. |
| Primary | Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period | From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period | An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug. |
| Secondary | Number of Participants Requiring Rescue Medication During the Double-blind Period | From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period | If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the acute repetitive seizure (ARS) episode. Each patient's specific criteria for seizure and an episode of ARS were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. An episode of ARS was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged. |
| Secondary | Number of Participants Requiring Emergency Department Visits During the Double-blind Period | From 15 minutes to 12 hours following study drug administration for onset of an episode of ARS during the Double-blind Period | Any use of emergency treatment (such as an emergency room visit) was recorded in the patient's diary, along with the date, time, and reason for the emergency treatment. Emergency department visits required some type of rescue action taken, other than the visit itself. An episode of acute repetitive seizures (ARS) was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged. |
| Secondary | Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period | From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period | Other rescue medical care consisted of care other than rescue medication or emergency department visits. Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. An episode of ARS was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged. |
| Secondary | Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period | Assessments completed at the end of each treated episode of ARS in the Double-blind Period | Caregiver global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged. |
| Secondary | Mean Score on Physician Global Treatment Assessment During the Double-blind Period | At Visit 2 and subsequent visits in the Double-blind Period | Physician global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes. The physician global evaluation is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged. |
| Secondary | Number of Participants Requiring Rescue Medication During the Open-label Period | From 15 minutes to 12 hours after study drug administration during the Open-label Period | Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. |
| Secondary | Number of Participants Requiring Emergency Department Visits During the Open-label Period | From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period | Any use of emergency treatment (such as an emergency room visit) was recorded in the patient's diary, along with the date, time, and reason for the emergency treatment. Emergency department visits required some type of rescue action taken, other than the visit itself. |
| Secondary | Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period | From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period | Other rescue medical care consisted of care other than rescue medication or emergency department visits. Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile) | From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period | All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period. | Hours | MEDIAN |
| PRIMARY | Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period | From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period | All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Requiring Rescue Medication During the Double-blind Period | From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period | All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS during the Double-blind Period. | Participants | NUMBER |
| SECONDARY | Number of Participants Requiring Emergency Department Visits During the Double-blind Period | From 15 minutes to 12 hours following study drug administration for onset of an episode of ARS during the Double-blind Period | All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period. | Participants | NUMBER |
| SECONDARY | Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period | From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period | All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period. | Participants | NUMBER |
| SECONDARY | Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period | Assessments completed at the end of each treated episode of ARS in the Double-blind Period | All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period. | Units on a scale | MEAN |
| SECONDARY | Mean Score on Physician Global Treatment Assessment During the Double-blind Period | At Visit 2 and subsequent visits in the Double-blind Period | All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period. | Units on a scale | MEAN |
| SECONDARY | Number of Participants Requiring Rescue Medication During the Open-label Period | From 15 minutes to 12 hours after study drug administration during the Open-label Period | All randomized participants in whom an attempt (successful or not) was made to administer study drug for an ARS episode during the Open-label Period of the study. | Participants | NUMBER |
| SECONDARY | Number of Participants Requiring Emergency Department Visits During the Open-label Period | From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period | All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period. | Participants | NUMBER |
| SECONDARY | Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period | From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period | All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period. | Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile) | Diazepam | 5.92 | 95% Confidence Interval 2.28 to NA | Hours | |
| Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile) | Placebo | NA | 95% Confidence Interval NA to NA | Hours | |
| Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period | Diazepam | 22.4 | NA to NA | Percentage of participants | |
| Number of Participants Requiring Rescue Medication During the Double-blind Period | Diazepam | 14 | Participants | ||
| Number of Participants Requiring Rescue Medication During the Double-blind Period | Placebo | 24 | Participants | ||
| Number of Participants Requiring Emergency Department Visits During the Double-blind Period | Diazepam | 2 | Participants | ||
| Number of Participants Requiring Emergency Department Visits During the Double-blind Period | Placebo | 4 | Participants | ||
| Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period | Diazepam | 0 | Participants | ||
| Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period | Placebo | 2 | Participants | ||
| Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period | Diazepam | 6.2 | Standard Deviation 2.79 | Units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period | STARTED | Diazepam | 124 | |
| Double-blind Period | STARTED | Placebo | 110 | |
| Double-blind Period | Received Treatment | Diazepam | 82 | |
| Double-blind Period | Received Treatment | Placebo | 81 | |
| Double-blind Period | COMPLETED | Diazepam | 81 | |
| Double-blind Period | COMPLETED | Placebo | 78 | |
| Double-blind Period | NOT COMPLETED | Diazepam | 43 | |
| Double-blind Period | NOT COMPLETED | Placebo | 32 | |
| Open-label Period | STARTED | Diazepam | 161 | |
| Open-label Period | STARTED | Placebo | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events724
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | INJECTION SITE PAIN | General disorders | Diazepam (Double-blind Period) | 14 | 81 | |
| other | INJECTION SITE PAIN | General disorders | Diazepam (Open-label Period) | 15 | 128 | |
| other | INJECTION SITE PAIN | General disorders | Diazepam (Open-label Extension) | 2 | 33 | |
| other | INJECTION SITE PAIN | General disorders | Placebo (Double-blind Period) | 11 | 79 | |
| other | INJECTION SITE HEMORRHAGE | General disorders | Diazepam (Double-blind Period) | 4 | 81 | |
| other | INJECTION SITE HEMORRHAGE | General disorders | Diazepam (Open-label Period) | 12 | 128 | |
| other | INJECTION SITE HEMORRHAGE | General disorders | Diazepam (Open-label Extension) | 0 | 33 | |
| other | INJECTION SITE HEMORRHAGE | General disorders | Placebo (Double-blind Period) | 5 | 79 | |
| other | INJECTION SITE BRUISING | General disorders | Diazepam (Double-blind Period) | 2 | 81 | |
| other | INJECTION SITE BRUISING | General disorders | Diazepam (Open-label Period) | 8 | 128 |
1 to 10 of 724Source ClinicalTrials.gov
See all 724 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diazepam (Double-blind Period) | ||
| Total, all-cause mortality | Diazepam (Open-label Period) | ||
| Total, all-cause mortality | Diazepam (Open-label Extension) | ||
| Total, all-cause mortality | Placebo (Double-blind Period) | ||
| Total, other adverse events | Diazepam (Double-blind Period) | 33 | 81 |
| Total, other adverse events | Diazepam (Open-label Period) | 43 | 128 |
| Total, other adverse events | Diazepam (Open-label Extension) | 20 | 33 |
| Total, other adverse events | Placebo (Double-blind Period) | 32 | 79 |
| Total, serious adverse events | Diazepam (Double-blind Period) | 2 | 81 |
| Total, serious adverse events | Diazepam (Open-label Period) | 20 | 128 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24111974 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Diazepam vs Placebo: Number of Participants Requiring Rescue Medication During the Double-blind Period | Trial comparisons |
| Diazepam vs Placebo: Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period | Trial comparisons |
| Diazepam vs Placebo: Number of Participants Requiring Emergency Department Visits During the Double-blind Period | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00319501
GET https://conductscience.org/api/trials/v1/NCT00319501/flow?page=2