Trial · NCT03340064
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 | Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6 | From Baseline (Week 0) to Visit 6 (up to Week 6) | The Full Analysis Set Adjunctive therapy (FAS\_A) consisted of all participants in the SS\_A who had at least 1 post-Baseline efficacy assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change | MEDIAN |
| SECONDARY | Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 4 | From Baseline (Week 0) to Visit 4 (up to Week 2) | The FAS\_A consisted of all participants in the SS\_A who had at least 1 post-Baseline efficacy assessment. | percent change | MEDIAN |
| SECONDARY | Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 5 | From Baseline (Week 0) to Visit 5 (up to Week 4) | The FAS\_A consisted of all participants in the SS\_A who had at least 1 post-Baseline efficacy assessment. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy | From Baseline (Week 0), Week 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, EOS/EDV (up to Week 295), and Safety follow-up (up to Week 295) | The FAS\_A consisted of all participants in the SS\_A who had at least 1 post-Baseline efficacy assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Here, number analyzed signifies participants who were evaluable at specified time points. | percent change | MEDIAN |
| SECONDARY | Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy | From Baseline (Week 0), Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, EOS/EDV Week 2, EOS/EDV Week 4, and Safety follow-up (up to Week 295) | FAS\_A consisted of all participants in SS\_A who had at least 1 post-Baseline efficacy assessment. Here, number analyzed signifies participants who were at risk at each previous analysis visit (X-1). As per planned analysis, outcome categories ≥50%, ≥75% and 100% are overlapping, so that percentages of categories of this outcome measure can add up to more than 100%. Data for one participant assessed within study duration was mapped to Analysis Visit 35/Week 300 based on statistical plan. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy | From Baseline (Week 0), Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, and Safety follow-up (up to Week 295) | The FAS\_M consisted of all participants in the SS\_M who had at least 1 post-Baseline efficacy assessment. Here, number analyzed signifies participants who were evaluable at specified time points. | percent change | MEDIAN |
| SECONDARY | Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy | From Baseline (Week 0), Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, and Safety follow-up (up to Week 295) | The FAS\_M consisted of all participants in the SS\_M who had at least 1 post-Baseline efficacy assessment. Here, number analyzed signifies participants who were at risk at each previous analysis visit (X-1). As per planned analysis, outcome categories ≥50%, ≥75% and 100% are overlapping, so that percentages of categories of this outcome measure can add up to more than 100%. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the First Period | From Baseline (Week 0) to Visit 6 (up to Week 6) | The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the First Period | From Baseline (Week 0) to Visit 6 (up to Week 6) | The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the First Period | From Baseline (Week 0) to Visit 6 (up to Week 6) | The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With TEAEs During the Combined First and Second Period | From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295) | The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent SAEs During the Combined First and Second Period | From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295) | The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the Combined First and Second Period | From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295) | The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period. | 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.
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