Trial · NCT03208660
Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
NCT03208660, Completed, Eisai Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy. Trials, record NCT03208660. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03208660
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
- NCT number
- NCT03208660
- Status
- Completed
- Enrollment
- 2,000 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Epilepsy
- Interventions
- Fycompa
- First posted
- 2017-07-05
- Last updated
- 2019-04-11
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate) | 3, 6, 12, 18, and 24 months | Retention rate is the ratio of the number of participants remaining on Fycompa treatment to the number of participants who could have been exposed for that length of time. |
| Secondary | Number of participants with a 50% response rate | up to 24 months | The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used. |
| Secondary | Number of participants with a 75% response rate | up to 24 months | The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used. |
| Secondary | Number of participants with a 100% response rate | up to 24 months | The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used. |
| Secondary | Categorized percent reduction in seizure frequency from baseline | Baseline, up to 24 months | An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure). |
| Secondary | Median percent change in seizure frequency from baseline | Baseline, up to 24 months | An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure). |
| Secondary | Percentage of participants who had no change or a worsening of seizures from baseline | Baseline, up to 24 months | An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure). |
| Secondary | Total provider health care visits before, during, and after final dose of Fycompa | 6 months before initiation of Fycompa to 6 months after last dose of Fycompa | Total provider health care visits before, during, and after final dose of Fycompa will be summarized as a safety variable. |
| Secondary | Number of participants with any treatment-emergent (TE) serious adverse event (SAE) resulting in discontinuation of Fycompa | Up to 24 months | An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (ie, the participant was at immediate risk of death from the adverse events \[AE\] as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. |
| Secondary | Number of participants with any treatment-emergent adverse event (TEAE) resulting in discontinuation of Fycompa | Up to 24 months | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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.
Papers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT03208660
GET https://conductscience.org/api/trials/v1/NCT03208660/registered