Trial · NCT02834793
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Core Study Phase: Median Percent Change in Drop Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Baseline up to 18 weeks | The full analysis set (FAS) was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. | percent change | MEDIAN |
| SECONDARY | Core Study Phase: Median Percent Change in Total Seizure Frequency Per 28 Days During Double-blind Treatment Relative to the Prerandomization Phase (Baseline) | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. | percent change | MEDIAN |
| SECONDARY | Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. | percentage of participants | NUMBER |
| SECONDARY | Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Total Seizures | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of study drug and had at least one post-dose seizure measurement. | percentage of participants | NUMBER |
| SECONDARY | Core Study Phase: Median Percent Change in Non-drop Seizure Frequency Per 28 Days During Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of study drug and had at least one post-dose seizure measurement. Here overall number of participants analyzed were participants who were evaluable for this outcome measure. | percent change | MEDIAN |
| SECONDARY | Core Study Phase: Percentage of Participants With 75% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures, Non-drop Seizures and Total Seizures | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. Here number analyzed were participants who were evaluable for the outcome measure at given categories. | percentage of participants | NUMBER |
| SECONDARY | Core Study Phase: Percentage of Participants With 100% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Drop Seizures, Non-drop Seizures and Total Seizures | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. Here number analyzed were participants who were evaluable for the outcome measure at given categories. | percentage of participants | NUMBER |
| SECONDARY | Core Study Phase: Percentage of Participants With 50% Response in the Maintenance Period of the Double-blind Treatment Phase Relative to the Prerandomization Phase (Baseline) for Non-drop Seizures | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of the study drug and had at least one post-dose seizure measurement. Here overall number of participants analyzed were participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Core Study Phase: Percentage of Participants With Clinical Global Impression of Change Scores (CGIC) in the Double-blind Treatment Phase | Baseline up to 18 weeks | The FAS was the group of randomized participants who received at least one dose of study drug and had at least one post-dose seizure measurement. Here overall number of participants analyzed were participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the date of the first administration of the study drug up to 28 days after the last dose of the study drug (up to 192 weeks) | SAS was group of participants who received at least one dose of study drug and had at least one post-dose safety assessment. As per the planned safety analysis, safety data for Extension A and Extension B was reported together as 'Extension Phase' arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Values | From the date of the first administration of the study drug up to 28 days after the last dose of the study drug (up to 192 weeks) | SAS was group of participants who received at least one dose of study drug and had at least one post-dose safety assessment. As per the planned safety analysis, safety data for Extension A and Extension B was reported together as 'Extension Phase' arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Vital Signs | From the date of the first administration of the study drug up to 28 days after the last dose of the study drug (up to 192 weeks) | SAS was group of participants who received at least one dose of the study drug and had at least one post-dose safety assessment. As per the planned safety analysis, safety data for Extension A and Extension B was reported together as 'Extension Phase' arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Core Study Phase: Model Predicted Average Perampanel Concentrations at Steady State (Cav,ss) During the Maintenance Period of Core Study Phase | Up to Week 18 | The PK analysis set was the group of participants who received perampanel or placebo who had seizure frequency data with documented dosing history. As population PK and PK/PD analysis were not conducted, therefore data was not collected and analyzed. |
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/NCT02834793/outcomes