Trial · NCT04257604
A Study of Perampanel as Add-on Therapy in Adult and Adolescent Participants With Focal Seizures
NCT04257604, Completed, Eisai Limited
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Perampanel as Add-on Therapy in Adult and Adolescent Participants With Focal Seizures. Trials, record NCT04257604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04257604
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Perampanel as Add-on Therapy in Adult and Adolescent Participants With Focal Seizures
- NCT number
- NCT04257604
- Status
- Completed
- Enrollment
- 243 participants, actual
- Lead sponsor
- Eisai Limited
- Conditions
- Partial Seizures
- Interventions
- Perampanel
- First posted
- 2020-02-06
- Last updated
- 2020-02-06
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline in all Seizures Frequency at Month 6 | Baseline, Month 6 | Seizure frequency is derived from information (seizure count and type) recorded in participant diary. Seizure frequency is based on the number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. |
| Secondary | Percentage of Participants Remaining on Perampanel at Months 6 and 12 | Months 6 and 12 | The retention rate is defined as the percentage of participants remaining on perampanel, starting from the first dose of study drug. |
| Secondary | Percentage of Participants With Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs) | Up to Month 12 | ADR is a noxious and unintended response to a medicinal product related to any dose. A causal relationship between the medicinal product and the adverse response is at least a reasonable possibility. A SADR is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization¸ results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. |
| Secondary | Percentage of Participants Who Withdraw due to ADR | Up to Month 12 | ADR is a noxious and unintended response to a medicinal product related to any dose. A causal relationship between the medicinal product and the adverse response is at least a reasonable possibility. |
| Secondary | Percentage of Participants Who Withdraw due to Lack of Efficacy | Up to Month 12 | Lack of efficacy is if the participant had poor seizure control (defined as experiencing a seizure despite being on the maximum dose for equal to 2 weeks). The participant can withdraw at any time due to lack of efficacy. |
| Secondary | Mean Change From Baseline in the Number of Concomitant Anti-epileptic Drugs (AEDs) | Baseline up to Month 12 | Change from baseline in the number of concomitant AEDs along with the Perampanel will be reported. |
| Secondary | Percentage of Participants With at Least 50 Percent (%) and 75% Reduction From Baseline in All Seizure Frequency at Months 3, 6 and 12 | Baseline, Months 3, 6, and 12 | A 50% or 75% responder rate is percentage of participants who experience at least 50% or 75% reduction in all seizure frequency during the study. |
| Secondary | Percentage of Participants With at Least 50% and 75% Reduction From Baseline in Secondarily Generalized Tonic-clonic Seizures (SGTCS) Frequency at Months 3, 6 and 12 | Baseline, Months 3, 6, and 12 | A 50% or 75% responder rate for SGTCS is percentage of participants who experience at least 50% or 75% reduction of SGTCS frequency during the study. Focal to bilateral toni-clonic seizures (FBTCS) replaces older term SGTCS. FBTCS is a seizure type with focal onset, with awareness or impaired awareness, either motor or nonmotor, progressing to bilateral tonic-clonic activity. |
| Secondary | Percentage of Participants Who Were Seizure-free | Up to Month 12 | Participants will be considered seizure-free if participants will not experience any partial-onset seizure during the study. |
| Secondary | Median Percentage Change From Baseline in All Seizure Frequency at Months 3 and 12 | Baseline, Months 3 and 12 | Seizure frequency is based on the number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41724127 | DERIVED |
Source PubMed
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/NCT04257604
GET https://conductscience.org/api/trials/v1/NCT04257604/registered