Status EpilepticusNCT03905798
LORA-PITA IV General Investigation
An observational study of Status Epilepticus, run by Pfizer at 1 site in Japan.
Trial summary
Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Lorazepam
- Type of treatment
- Injection or infusion
- How many people
- 206 participants
- Where
- 1 siteJapan
- Study dates
- 18 Nov 2019to 15 Nov 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
Inclusion Criteria: Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LORA-PITA (REGISTERED) Intravenous Injection 2 mg General Investigation
Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.
Read the detailed description
To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA for Status Epilepticus patients in Japan.
- Conditions
- Status Epilepticus
- Being tested
- Lorazepam
- Keywords
- Status Epilepticus;, Lorazepam;, LORA-PITA;, Ativan
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorazepamDrug
Also called LORA-PITA
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.
| Study group | Role | What they receive |
|---|---|---|
| Lorazepam | Patients administered Lorazepam in accordance with the indication (for Status Epilepticus, SE) and have no history of using this drug Receives: Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the Participants With Adverse Drug Reactions
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.
Measured: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.
Secondary outcomes (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 (Participants in Whom LORA-PITA Was Used as the First-line Treatment)
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.
Measured: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.
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)
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.
Measured: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start18 Nov 2019
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905798
- Sponsor's protocol ID
- B3541003
- Other IDs
- NCT03905798
- Status last verified
- Feb 2025
- First submitted
- 4 Apr 2019
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LORA-PITA (REGISTERED) Intravenous Injection 2 mg General Investigation
- ClinicalTrials.gov ID
- NCT03905798
- Acronym / sponsor ID
- B3541003
- Conditions
- Status Epilepticus
- Keywords
- Status Epilepticus;, Lorazepam;, LORA-PITA;, Ativan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Posted 10 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.
Detailed description
To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA for Status Epilepticus patients in Japan.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lorazepam | – | Drug: LorazepamPatients administered Lorazepam in accordance with the indication (for Status Epilepticus, SE) and have no history of using this drug |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LorazepamAlso: LORA-PITAThe 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. | Drug | Lorazepam |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Status Epilepticus, run by Pfizer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.