Skip to main content
OpenTrials
Completed

NCT Number: NCT03905798

LORA-PITA IV General Investigation

Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Status Epilepticus Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

3 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Local Country office

Tokyo, Shibuya-ku, Japan

About this study

To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA for Status Epilepticus patients in Japan.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.

Treatment and study plan

Lorazepam

Drug

The usual dose of lorazepam in adults is 4 mg administered intravenously. The drug should be given slowly with the administration rate at 2 mg/min as a guide. If necessary, 4 mg may be added but the dose should not exceed 8 mg as the sum of initial and additional doses.

The usual dose of lorazepam in children aged 3 months or older is 0.05 mg/kg (up to 4 mg) administered intravenously. The drug should be given slowly with the administration rate at 2 mg/min as a guide. If necessary, 0.05 mg/kg may be added but the dose should not exceed 0.1 mg/kg as the sum of initial and additional doses.

Other names: LORA-PITA

Primary outcomes

  1. Number of the Participants With Adverse Drug Reactions

    Time frame: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.

    An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to LORA-PITA in a participant who received LORA-PITA. A serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to LORA-PITA was assessed by the physician.

Secondary outcomes

  1. Proportion of Participants Whose Initial Seizure Stopped Within 10 Minutes After the Administration of Final Dose and Who Continued Seizure-free for at Least 30 Minutes (Participants in Whom LORA-PITA Was Used as the First-line Treatment)

    Time frame: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.

    Epileptic seizures subject to treatment with LORA-PITA were evaluated as effectiveness evaluation.

    Definition of responders to the first or second administration of LORA-PITA: A responder was defined as a participant whose seizure resolved within 10 minutes after the first administration of LORA-PITA or the second administration (10 to 30 minutes after the first administration) and who did not require additional treatment with other drugs for the target disease within 30 minutes after the end of administration (excluding prophylactic administration) and had no recurrent seizure.

  2. Proportion of Participants Whose Initial Seizure Stopped Within 10 Minutes After the Administration of Final Dose and Who Continued Seizure-free for at Least 30 Minutes (Efficacy Analysis Set)

    Time frame: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.

    Epileptic seizures subject to treatment with LORA-PITA were evaluated as effectiveness evaluation.

    Definition of responders to the first or second administration of LORA-PITA: A responder was defined as a participant whose seizure resolved within 10 minutes after the first administration of LORA-PITA or the second administration (10 to 30 minutes after the first administration) and who did not require additional treatment with other drugs for the target disease within 30 minutes after the end of administration (excluding prophylactic administration) and had no recurrent seizure.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

LORA-PITA (REGISTERED) Intravenous Injection 2 mg General Investigation

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 5, 2019
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.