DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Status Epilepticus

Intervention: Lorazepam (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Summary

The purpose of this study is to determine the efficacy, safety and pharmacokinetics of Lorazepam on Japanese patients with Status Epilepticus or Repetitive Status Eplilepticus.

Clinical Details

Official title: A Multi-center, Open-label, Non-controlled Study To Evaluate The Efficacy And Safety Of Lorazepam Intravenously Administered In Subjects With Status Epilepticus Or Repetitive Status Epilepticus

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Clinical Benefit

Secondary outcome:

Percent of participants whose initial seizure stopped within 10 minutes after the administration of study drug (either initial or second dose [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 30 minutes.

Percent of participants whose seizures stopped within 10 minutes after the administration of study drug (only the initial dose) and who continued seizure-free for at least 12 hours post-dose.

Percent of participants whose seizures stopped within 10 minutes after the administration of study drug (either initial or second dose [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 12 hours post-dose.

Percent of participants whose seizures stopped within 10 minutes after the administration of study drug (only the initial dose) and who continued seizure-free for at least 24 hours post-dose.

Percent of participants whose seizures stopped within 10 minutes after the administration of study drug (either initial or second dose [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 24 hours post-dose.

Time to resolution of seizures from the administration of study drug (only the initial dose).

Time to resolution of seizures from the administration of study drug (either initial or second dose).

Time to relapse from the resolution of seizures following the administration of study drug (only the initial dose, within 24 hours).

Time to relapse from the resolution of seizures following the administration of study drug (either initial or second dose, within 24 hours).

Eligibility

Minimum age: 3 Months. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with status epilepticus or repetitive status epilepticus / cluster seizure

who have seizures that can be evaluated by investigator's visual observations based on motor symptoms or who have seizures that can be evaluated by EEG.

- Subjects with status epilepticus accompanied by generalized seizure, partial seizure

or secondarily generalized seizure lasting 5 minutes or longer

- Subjects with repetitive status epilepticus / cluster seizure accompanied by not less

than 3 consecutive episodes of generalized seizure, partial seizure or secondarily generalized seizure in 1 hour.

- Subjects not younger than 3 months (either gender is eligible for the study)

Exclusion Criteria:

- Subjects with known or suspected recurrent seizures due to illegal drug or alcohol

withdrawal

- Subjects with known history of hypersensitivity to lorazepam or benzodiazepine

- Subjects with a known history of benzodiazepine abuse.

- Subjects currently receiving lorazepam

- Subjects with angle-closure glaucoma

- Subjects with myasthenia gravis

- Subjects with either of aspartate transaminase, alanine transaminase, total

bilirubin, blood urea nitrogen, or creatinine at screening visit exceeding 2x the upper limit of normal of the institutional reference value (if the data is available)

- Subjects with white blood cell count less than 3000/mm3 or neutrophil count less than

1500/mm3 at screening visit (if the data is available)

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Fukuoka Sanno Hospital, Fukuoka 814-0001, Japan; Recruiting

Saitama Children's Medical Center, Saitama 339-8551, Japan; Recruiting

National Hospital Organization Fukuoka-Higashi Medical Center, Koga, Fukuoka 811-3195, Japan; Recruiting

Nakamura Memorial Hospital, Sapporo, Hokkaido 060-8570, Japan; Recruiting

National Hospital Organization Hokkaido Medical Center, Sapporo, Hokkaido 063-0005, Japan; Recruiting

Tohoku University Hospital, Sendai, Miyagi 980-8574, Japan; Recruiting

National Hospital Organization Nagasaki Medical Center, Ohmura, Nagasaki 856-8562, Japan; Not yet recruiting

National Nishi-Niigata Central Hospital / Pediatrics, Niigata-shi, Niigata 950-2085, Japan; Recruiting

Okayama University Hospital / Child Neurology, Okayama-shi, Okayama 700-8558, Japan; Active, not recruiting

Osaka Medical Center and Research Institute for Maternal and Child Health, Izumi, Osaka 594-1101, Japan; Recruiting

Osaka City General Hospital, Miyakojima-ku, Osaka 534-0021, Japan; Recruiting

NHO Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka-city, Shizuoka, Japan; Recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2014
Last updated: August 12, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017