Comparison · NCT01634360-sae
Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study) vs Perampanel (Placebo During Core Study): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study) vs Perampanel (Placebo During Core Study): serious adverse events. Trial comparisons, record NCT01634360-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01634360-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.291 | 0.221 | 0.373 | wilson | |
| Risk in group 2 | 0.271 | 0.166 | 0.41 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0202 | -0.136 | 0.153 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.63 | 1.83 | log | |
| Odds ratio, group 1 over group 2 | 1.11 | 0.529 | 2.31 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study) than on Perampanel (Placebo During Core Study) | 49.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study) | Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. | 39 | 134 | EG001 |
| Group 2 | Perampanel (Placebo During Core Study) | Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. | 13 | 48 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
Source ClinicalTrials.gov
Trial
- Title
- Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations
- NCT number
- NCT01634360
- Phases
- PHASE2
- Conditions
- Parkinson's Disease
- Interventions
- Perampanel
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2013-02-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01634360?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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