midazolam and Convulsive Generalized Seizure Disorder

midazolam has been researched along with Convulsive Generalized Seizure Disorder in 9 studies

Midazolam: A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.
midazolam : An imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively.

Research

Studies (9)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Duration of Safety Observation

Duration of participant study participation for collection of long term safety data (NCT01529034)
Timeframe: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.

Emergency Room/Emergency Medical Service Visits

Participants requiring emergency room (ER)/emergency medical service (EMS) visit within 24 hours after any USL261 treated seizure cluster (including for continued seizures) (NCT01529034)
Timeframe: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.

Number of Treated Seizure Clusters Meeting Criteria for Treatment Success

Number of Treated Seizure Clusters Meeting Criteria for Treatment Success: Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after administration of first dose of USL261 (intranasal midazolam 5 mg) (NCT01529034)
Timeframe: 6 hours after first dose of USL261 for each treated seizure cluster

Participant Change in B-SIT Score

Change in participant Brief Smell Identification Test (B-SIT) score from baseline to last visit with assessment. The B-SIT is a self-administered 12-item test; the score indicates odors correctly identified (0 to 12). The B-SIT was added while the study was already ongoing (Protocol Amendment 4, 20 May 2015) in response to a regulatory request. The test was only implemented at sites in the United States and included only participants considered by the investigator to have adequate cognitive ability to perform the test. Baseline was defined as the latest non-missing value prior to administration of USL261 in the Test Dose Phase of Study P261-401. (NCT01529034)
Timeframe: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.

Participants With Clinically Significant Abnormalities on Nasal Examination

Participants with abnormal findings, at any time post baseline, on nasal examination considered clinically significant by the investigator (NCT01529034)
Timeframe: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.

Participants Meeting Predefined Safety Criteria for Vital Signs

Participants meeting predefined safety criteria for vital signs (systolic blood pressure [SBP] <85 mm Hg, SBP change from baseline >/= 40 mm Hg, diastolic BP [DBP] <50 mm Hg, DBP change from baseline >/=30 mm Hg, pulse rate <50 beats per minute (bpm), pulse rate >120 bpm, pulse rate change >/= 40 bpm at any visit post baseline or for caregiver recorded participant respiration rate [RR] <8 breaths per minute (brpm) or >24 brpm) after any USL261 treated seizure cluster episode. Abnormal vital signs were assessed separately by investigator and recorded as adverse events if applicable. (NCT01529034)
Timeframe: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.

Participants With Clinically Significant Abnormalities on Neurologic Examination

Participants with abnormal findings, at any time post baseline, on neurologic examination considered clinically significant by the investigator (NCT01529034)
Timeframe: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.

Participants With Clinically Significant Abnormalities Physical Examination

Participants with abnormal findings, at any time post baseline, on physical examination considered clinically significant by the investigator. (NCT01529034)
Timeframe: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.

Participants With Laboratory Abnormalities Meeting Predefined Criteria

Participants with abnormal laboratory finding, at any time post baseline, meeting predefined criteria. Abnormal laboratory findings were assessed separately by investigator and recorded as adverse events if applicable. Alanine aminotransferase (ALT); Alkaline phosphatase (ALP); Aspartate aminotransferase (AST); Gamma glutamyl transferase (GGT); upper limit of normal (ULN) (NCT01529034)
Timeframe: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.

Participants With Suicidal Ideation

Participants with suicidal ideation reported on Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at any post-baseline visit. Responses including: Wish to be Dead; Non-Specific Active Suicidal Thoughts; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent; and Any Suicidal Ideation Regardless of Type. (NCT01529034)
Timeframe: From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.

Length of Seizure After Study Medication Administration

Length of seizure. (NCT00326612)
Timeframe: 24 hours

Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication.

(NCT00326612)
Timeframe: 24 hours

Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication.

(NCT00326612)
Timeframe: 24 hours

Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication

(NCT00326612)
Timeframe: 12 hours

Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours

(NCT00326612)
Timeframe: 24 hours

Respiratory Depression Requiring Intubation

Respiratory depression was defined as intubation at Emergency Department discharge. (NCT00326612)
Timeframe: 24 hours

Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department.

Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department. (NCT00326612)
Timeframe: 24 hours

Reviews

2 reviews available for midazolam and Convulsive Generalized Seizure Disorder

Trials

2 trials available for midazolam and Convulsive Generalized Seizure Disorder

Other Studies

5 other studies available for midazolam and Convulsive Generalized Seizure Disorder