N/A
Completed N=206
LORA-PITA IV General Investigation
Source: ClinicalTrials.gov NCT03905798 ↗Enrolled (actual)
206
Serious AEs
0.9%
Results posted
Mar 2025
Primary outcomePrimary: Number of the Participants With Adverse Drug Reactions — 7 Participants
Summary
Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of the Participants With Adverse Drug Reactions |
7 | — |
| 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) |
64.3 | — |
| 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) |
62.5 | — |
Eligibility Criteria
Inclusion Criteria: Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
Data sourced from ClinicalTrials.gov (NCT03905798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.