Trial · NCT01389596
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase | Baseline phase (up to 8 weeks prior to treatment phase [Day 1]) | Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. | Seizures per 28 days | MEAN |
| PRIMARY | Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase | Day 1 up to Week 12 | ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. Here, Number of Participants Analyzed (N) signifies number of participants who were evaluable for this outcome measure. | Seizures per 28 days | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase | Day 1 up to Week 12 | ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) | Safety population included all randomized participants who took at least 1 dose of the study drug. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) | Safety population included all randomized participants who took at least 1 dose of the study drug. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Adverse Events by Severity | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) | Safety population included all randomized participants who took at least 1 dose of the study drug. | events | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories At Baseline | Baseline (4 week prior to Day 1 of treatment) | Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories During Post Baseline Time Period | Day 1 up to Week 13 | Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) | Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively. | T scores | MEAN |
| OTHER_PRE_SPECIFIED | Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) | Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively. | T scores | MEAN |
| OTHER_PRE_SPECIFIED | Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) | Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively. | T scores | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Cognitive Test Battery (CogState Battery) Scores at Week 12: Detection Task | Baseline (pre-dose at Day 1), Week 12 | Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively. | log10 milliseconds | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: Attention) Tasks | Baseline (pre-dose at Day 1), Week 12 | Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively. | log10 milliseconds | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Clinically Significant Laboratory Abnormalities | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 | Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Vital Signs Abnormalities | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 | Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Clinically Significant Change From Baseline in Neurological Examinations | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 | Safety population included all randomized participants who took at least 1 dose of the study drug. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Electrocardiogram (ECG) Abnormalities | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 | Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Clinically Significant Change From Baseline in Physical Examinations at Week 13 | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 | Safety population included all randomized participants who took at least 1 dose of the study drug. | 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
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GET https://conductscience.org/api/trials/v1/NCT01389596/outcomes