Trial · NCT03208660
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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. |
| Secondary | Mean change in body weight from baseline | Baseline, Up to 24 months | Change from baseline is calculated as the post-baseline value minus the baseline value. |
| Secondary | Mean change in height of pediatric participants from baseline | Baseline, Up to 24 months | Change from baseline is calculated as the post-baseline value minus the baseline value. |
| Secondary | Maximum dose of Fycompa | Up to 24 months | The extent of exposure of Fycompa will be determined by summarizing the maximum dose of the study drug. |
| Secondary | Average dose of Fycompa | Up to 24 months | The extent of exposure of Fycompa will be determined by summarizing the average dose of the study drug. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT03208660/registered