Trial · NCT04309721
Perampanel in Focal Status Epilepticus
NCT04309721, Phase 3, Terminated, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Perampanel in Focal Status Epilepticus. Trials, record NCT04309721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04309721
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Perampanel in Focal Status Epilepticus
- NCT number
- NCT04309721
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1 participants, actual
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Epilepticus; Status, Focal Motor
- Interventions
- Perampanel, Placebo
- First posted
- 2020-03-16
- Last updated
- 2023-12-14
- Other registries' IDs
- eudract:2019-000882-19
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Administration or not of either (i) an additional second-line antiepileptic drug, either intravenous or orally, or (ii) a third-line (anesthetic drug) | Within de 6 hours after the perampanel or placebo administration | Administration or not of either (i) an additional second-line antiepileptic drug, either intravenous or orally, or (ii) a third-line (anesthetic drug), within the 6 hours following study drug (perampanel or placebo) administration |
| Secondary | Seizure cessation | at 3 hours and 6 hours after the perampanel or placebo administration | Seizure cessation is defined clinically by the interruption of any epileptic movements (clonic, tonic or myoclonic) |
| Secondary | Time to seizure cessation | within the 6 hours after the administration of perampanel or placebo | |
| Secondary | The need for endotracheal intubation | within the 24 hours after the administration of perampanel or placebo | |
| Secondary | Percentage of patients with altered consciousness | at 3 hours and 6 hours after the perampanel or placebo administration | Altered consciousness is defined as Glascow Coma Scale (GCS) \<8 |
| Secondary | Duration of hospitalization | From randomization untill 14 days after the administration of perampanel or placebo | Duration of overall hospitalization (ICU/step down/standard hospitalisation) and duration of hospitalization in ICU/step down unit, both censored 14 days after randomisation |
| Secondary | Rate of patient with seizure recurrence | From hour 3 until hour 24 after the administration of perampanel or placebo | Seizure recurrence is defined as focal motor seizure lasting less than 10 minutes, between hour 3 and hour 24 after the administration of perampanel or placeb. Recurrence is defined by reappearance of epileptic movements after a period of at least one hour of seizure cessation |
| Secondary | Rate of patient with status epilepticus recurrence, in patients with seizure cessation | From hour 3 until hour 24 after the administration of perampanel or placebo | Status epilepticus recurrence is defined as focal motor seizure lasting 10 minutes or more, or repeated focal motor seizures (≥4 seizures in 10 min), between hour 3 and hour 24 after the administration of perampanel or placebo. |
| Secondary | Rate of patients with secondary generalized seizures | From hour 0 until hour 24 after the administration of perampanel or placebo | Secondary generalized seizures is defined as convulsive tonic or clonic bilateral seizure lasting less than 5 minutes |
| Secondary | Progression to a convulsive generalized status epilepticus | From hour 0 until hour 24 after the administration of perampanel or placebo | Convulsive generalized status epilepticus is defined as convulsive tonic or clonic bilateral seizure lasting more than 5 minutes or more, or 2 or more seizures in 5 minutes without recovery of consciousness between the seizures |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT04309721
GET https://conductscience.org/api/trials/v1/NCT04309721/registered