Trial · NCT03905798
LORA-PITA IV General Investigation
NCT03905798, Completed, Pfizer; results first posted 2025-03-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LORA-PITA IV General Investigation. Trials, record NCT03905798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03905798
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LORA-PITA IV General Investigation
- NCT number
- NCT03905798
- Status
- Completed
- Enrollment
- 206 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Status Epilepticus
- Interventions
- Lorazepam
- First posted
- 2019-04-05
- Last updated
- 2025-03-10
- Results first posted
- 2025-03-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of the Participants With Adverse Drug Reactions | 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 | 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) | 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. |
| Secondary | 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) | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of the Participants With Adverse Drug Reactions | From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received LORA-PITA at least once. Participants without informed consent for notification/publication of study results were excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days. | The efficacy analysis set (84 participants) comprised of participants in the safety analysis set in whom LORA-PITA was used as the first-line treatment with evaluable effectiveness, excluding participants who met any of the following conditions: effectiveness evaluation has not been reported at all or the administration was as the second-line treatment. | Percentage of Participants | NUMBER |
| SECONDARY | 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) | From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days. | The efficacy analysis set (104 participants) comprised of participants in the safety analysis set in whom LORA-PITA was used and had evaluable effectiveness data. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of the Participants With Adverse Drug Reactions | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 7 | Participants | ||
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) | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 64.3 | 95% Confidence Interval 53.1 to 74.4 | Percentage of Participants | |
| 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) | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 62.5 | 95% Confidence Interval 52.5 to 71.8 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 206 | |
| Overall Study | COMPLETED | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 112 | |
| Overall Study | NOT COMPLETED | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 94 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bradycardia | Cardiac disorders | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 1 | 112 | |
| other | Blood pressure decreased | Investigations | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 2 | 112 | |
| other | Lymphocyte count decreased | Investigations | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 1 | 112 | |
| other | Renal impairment | Renal and urinary disorders | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 1 | 112 | |
| other | Respiratory arrest | Respiratory, thoracic and mediastinal disorders | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 1 | 112 | |
| other | Respiratory depression | Respiratory, thoracic and mediastinal disorders | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 1 | 112 | |
| other | Respiratory failure | Respiratory, thoracic and mediastinal disorders | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 3 | 112 | |
| serious | Ventricular tachycardia | Cardiac disorders | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 1 | 112 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 0 | 112 |
| Total, other adverse events | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 9 | 112 |
| Total, serious adverse events | LORA-PITA Intravenous Injection 2mg (Lorazepam) | 1 | 112 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03905798
GET https://conductscience.org/api/trials/v1/NCT03905798/registered