A Phase 3 interventional study of Placebo and Vanquix Auto-Injector (Diazepam Injection) in Seizures, Epilepsies, Partial and Epilepsy, Complex Partial, sponsored by Pfizer. Completed at 86 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2016-09-23.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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.
766 studies on the registry are indexed under Seizures; 136 are open to participants now.
This study's enrollment of 234 is above the median of 64 across 519 interventional studies indexed under Seizures.
Browse Seizures studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria
For Patient:
For Caregiver:
Age of 18 years or older and has demonstrated responsibility as a caregiver through training to:
Key Exclusion Criteria
For Patient:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
Drug: Placebo
During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, as a deep intramuscular injection in the mid to outer thigh. Additional doses were permissible during the Open-label Period. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
Drug: Vanquix Auto-Injector (Diazepam Injection)
Intramuscular autoinjector; administered at onset of an episode
Intramuscular autoinjector: 5, 10, 15, or 20 mg (based on participant's age and weight); administered at the onset of an episode
Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile)
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.
Time frame: From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period
Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label 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.
Time frame: From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period
Number of Participants Requiring Rescue Medication 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.
Time frame: From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period
Number of Participants Requiring Emergency Department Visits 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.
Time frame: From 15 minutes to 12 hours following study drug administration for onset of an episode of ARS during the Double-blind Period
Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits 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.
Time frame: From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period
Mean Score on Caregiver Global Treatment Assessment During 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.
Time frame: Assessments completed at the end of each treated episode of ARS in the Double-blind Period
Mean Score on Physician Global Treatment Assessment During 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.
Time frame: At Visit 2 and subsequent visits in the Double-blind Period
Number of Participants Requiring Rescue Medication 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.
Time frame: From 15 minutes to 12 hours after study drug administration during the Open-label Period
Number of Participants Requiring Emergency Department Visits 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.
Time frame: From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period
Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits 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.
Time frame: From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period
Mean Score on Caregiver Global Treatment Assessment During the Open-label 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.
Time frame: Assessments completed at the end of each treated episode of ARS in the Open-label Period
Mean Score on Physician Global Treatment Assessment During the Open-label Period
Physician 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.
Time frame: From Visit 2 and subsequent visits in the Open-label Period to discharge or study termination
| Milestone | Diazepam | Placebo |
|---|---|---|
| Started | 124 | 110 |
| Received treatment | 82 | 81 |
| Completed | 81 | 78 |
| Not completed | 43 | 32 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Sponsor request | 1 | 0 |
| Withdrew: Did not receive treatment | 42 | 29 |
| Milestone | Diazepam | Placebo |
|---|---|---|
| Started | 161 | 0 |
| Received treatment | 128 | 0 |
| Completed | 45 | 0 |
| Not completed | 116 | 0 |
| Withdrew: Adverse event | 5 | 0 |
| Withdrew: Protocol violation | 6 | 0 |
| Withdrew: Withdrawal by subject | 38 | 0 |
| Withdrew: Principal investigator decision | 6 | 0 |
| Withdrew: Sponsor request | 12 | 0 |
| Withdrew: Lost to follow-up | 5 | 0 |
| Withdrew: Did not receive treatment | 33 | 0 |
| Withdrew: Other | 11 | 0 |
| Milestone | Diazepam | Placebo |
|---|---|---|
| Started | 51 | 0 |
| Received treatment | 33 | 0 |
| Completed | 0 | 0 |
| Not completed | 51 | 0 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Did not receive treatment | 18 | 0 |
| Withdrew: Other | 1 | 0 |
| Withdrew: Principal investigator decision | 2 | 0 |
| Withdrew: Sponsor request | 26 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
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.
| Hours | Diazepam | Placebo |
|---|---|---|
| Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile) | 5.92 (2.28 to NA) | NA (NA to NA) |
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.
| Percentage of participants | Diazepam |
|---|---|
| Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period | 22.4 (NA to NA) |
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.
| Participants | Diazepam | Placebo |
|---|---|---|
| Number of Participants Requiring Rescue Medication During the Double-blind Period | 14 | 24 |
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.
| Participants | Diazepam | Placebo |
|---|---|---|
| Number of Participants Requiring Emergency Department Visits During the Double-blind Period | 2 | 4 |
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.
| Participants | Diazepam | Placebo |
|---|---|---|
| Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period | 0 | 2 |
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.
| Units on a scale | Diazepam | Placebo |
|---|---|---|
| Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period | 6.2 ± 2.79 | 5.5 ± 2.86 |
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.
| Units on a scale | Diazepam | Placebo |
|---|---|---|
| Mean Score on Physician Global Treatment Assessment During the Double-blind Period | 6.3 ± 2.45 | 5.5 ± 2.69 |
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.
| Participants | Diazepam |
|---|---|
| Number of Participants Requiring Rescue Medication During the Open-label Period | 39 |
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.
| Participants | Diazepam |
|---|---|
| Number of Participants Requiring Emergency Department Visits During the Open-label Period | 13 |
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.
| Participants | Diazepam |
|---|---|
| Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period | 5 |
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.
| Units on a scale | Diazepam |
|---|---|
| Mean Score on Caregiver Global Treatment Assessment During the Open-label Period | 6.78 ± 1.896 |
Physician 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.
| Units on a scale | Diazepam |
|---|---|
| Mean Score on Physician Global Treatment Assessment During the Open-label Period | 6.87 ± 1.645 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diazepam (Double-blind Period) | — | 2/81 (2.5%) | 33/81 (40.7%) |
| Diazepam (Open-label Period) | — | 20/128 (15.6%) | 43/128 (33.6%) |
| Diazepam (Open-label Extension) | — | 11/33 (33.3%) | 20/33 (60.6%) |
| Placebo (Double-blind Period) | — | 3/79 (3.8%) | 32/79 (40.5%) |
| Event | Diazepam (Double-blind Period) | Diazepam (Open-label Period) | Diazepam (Open-label Extension) | Placebo (Double-blind Period) |
|---|---|---|---|---|
| EPILEPSYNervous system disorders | 0/81 | 10/128 | 5/33 | 1/79 |
| GAIT DISTURBANCESGeneral disorders | 1/81 | 0/128 | 1/33 | 0/79 |
| PneumoniaInfections and infestations | 0/81 | 0/128 | 1/33 | 1/79 |
| STATUS EPILEPTICUSNervous system disorders | 0/81 | 1/128 | 1/33 | 0/79 |
| POSTICTAL STATENervous system disorders | 0/81 | 0/128 | 1/33 | 0/79 |
| CORNEAL ABRASIONInjury, poisoning and procedural complications | 0/81 | 0/128 | 1/33 | 0/79 |
| TOXICITY TO VARIOUS AGENTSInjury, poisoning and procedural complications | 0/81 | 0/128 | 1/33 | 0/79 |
| DEPRESSIONPsychiatric disorders | 0/81 | 1/128 | 1/33 | 0/79 |
| SUICIDAL IDEATIONPsychiatric disorders | 0/81 | 1/128 | 1/33 | 0/79 |
| RESPIRATORY DISTRESSRespiratory, thoracic and mediastinal disorders | 0/81 | 1/128 | 1/33 | 0/79 |
| Event | Diazepam (Double-blind Period) | Diazepam (Open-label Period) | Diazepam (Open-label Extension) | Placebo (Double-blind Period) |
|---|---|---|---|---|
| INJECTION SITE PAINGeneral disorders | 14/81 | 15/128 | 2/33 | 11/79 |
| HEADACHENervous system disorders | 2/81 | 22/128 | 1/33 | 2/79 |
| URINARY TRACT INFECTIONInfections and infestations | 0/81 | 5/128 | 4/33 | 0/79 |
| INJECTION SITE HEMORRHAGEGeneral disorders | 4/81 | 12/128 | 0/33 | 5/79 |
| EXCORIATIONInjury, poisoning and procedural complications | 1/81 | 0/128 | 3/33 | 0/79 |
| FALLInjury, poisoning and procedural complications | 0/81 | 0/128 | 3/33 | 0/79 |
| INSOMNIAPsychiatric disorders | 0/81 | 3/128 | 3/33 | 0/79 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 0/81 | 9/128 | 3/33 | 0/79 |
| VOMITINGGastrointestinal disorders | 1/81 | 10/128 | 1/33 | 1/79 |
| PYREXIAGeneral disorders | 2/81 | 9/128 | 1/33 | 2/79 |
Participants who were randomized to receive treatment
| Age, Continuous(years) | Diazepam | Placebo | Total |
|---|---|---|---|
| Mean | 22.8 ± 15.98 | 21.3 ± 12.92 | 22.1 ± 14.61 |
| Age, Customized(participants) | Diazepam | Placebo | Total |
|---|---|---|---|
| 2 to 5 years | 12 | 6 | 18 |
| 6 to 11 years | 18 | 14 | 32 |
| 12 years and older | 94 | 90 | 184 |
| Sex: Female, Male(Participants) | Diazepam | Placebo | Total |
|---|---|---|---|
| Female | 62 | 54 | 116 |
| Male | 62 | 56 | 118 |
| Ethnicity (NIH/OMB)(Participants) | Diazepam | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 15 | 9 | 24 |
| Not Hispanic or Latino | 109 | 101 | 210 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Diazepam | Placebo | Total |
|---|---|---|---|
| White/Caucasian | 104 | 89 | 193 |
| Black/African American | 13 | 17 | 30 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 0 |
| American Indian or Alaska Native | 0 | 0 | 0 |
| Other | 5 | 2 | 7 |
| Missing | 0 | 0 | 0 |
| Place of Residence(Participants) | Diazepam | Placebo | Total |
|---|---|---|---|
| Home | 123 | 107 | 230 |
| Foster home | 0 | 1 | 1 |
| Group home | 1 | 1 | 2 |
| Residential facility | 0 | 1 | 1 |
| Other | 0 | 0 | 0 |
| Height(Centimeters) | Diazepam | Placebo | Total |
|---|---|---|---|
| Mean | 154.2 ± 25.08 | 154.5 ± 22.61 | 154.4 ± 23.91 |
| Weight(Kilograms) | Diazepam | Placebo | Total |
|---|---|---|---|
| Mean | 61.0 ± 29.15 | 58.9 ± 28.47 | 60.0 ± 28.79 |
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Studies of the drug tested here: Diazepam