Trial · NCT01527006
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 0 to Week 15 | The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study. | Percent change | MEDIAN |
| PRIMARY | Apparent Clearance (CL/F) of Perampanel [Core Study] | From Day 8 up to Day 78 | The pharmacokinetic (PK) analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history. | Liter per hour | MEAN |
| SECONDARY | 50% Responder Rate During the Maintenance Period-LOCF [Core Study] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 9 to 11 | The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study. | Percent responders | NUMBER |
| SECONDARY | Seizure-free Rate During the Maintenance Period [Core Study] | Week 9 to Week 11 | The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study. | Percentage of participants | NUMBER |
| SECONDARY | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Week 0 (Baseline), Week 11 or EOT | The Full Analysis Set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study. | Participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase | The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase. | Participants | NUMBER |
| SECONDARY | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Week 5 or at the time of early discontinuation | The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment. | Participants | NUMBER |
| SECONDARY | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Week 5 or at the time of early discontinuation | The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment. | Participants | NUMBER |
| SECONDARY | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Week 5 or at the time of early discontinuation | The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment. | Participants | NUMBER |
| PRIMARY | Steady-state Average Concentration (C av,ss) of Perampanel [Core Study] | From Day 8 up to Day 78 | The PK analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history. | ng/mL | MEAN |
| SECONDARY | Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study] | Week 5 or at the time of early discontinuation | The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | The Effect of Demographics on Population PK Parameters: AUC | 11 weeks | This outcome was not assessed in the study. | ||
| OTHER_PRE_SPECIFIED | The Effect of Demographics on Population PK Parameters: Cmax | 11 weeks | This outcome was not assessed in the study. | ||
| OTHER_PRE_SPECIFIED | The Effect of Demographics on Population PK Parameters: Tmax | 11 weeks | This outcome was not assessed in the study. | ||
| OTHER_PRE_SPECIFIED | The Effect of the Most Common Concomitant AEDs on Population PK Parameters: AUC | 11 weeks | This outcome was not assessed in the study. | ||
| OTHER_PRE_SPECIFIED | The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Cmax | 11 weeks | This outcome was not assessed in the study. | ||
| OTHER_PRE_SPECIFIED | The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Tmax | 11 weeks | This outcome was not assessed in the study. | ||
| SECONDARY | Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52 | The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase. | Percent change | MEDIAN |
| SECONDARY | 50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52 | The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase. | Percentage of responders | NUMBER |
| SECONDARY | Seizure-free Rate During the Overall Treatment Duration [Extension Phase] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52 | The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase. | Percentage of participants | NUMBER |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01527006/outcomes