Trial · NCT00438451
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment | 58 weeks | |
| Secondary | Time to Drop Out | 58 weeks | number of days between randomization and premature discontinuation of the study |
| Secondary | Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4) | Week 30 | Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30. |
| Secondary | Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6) | week 58 | Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58. |
| Secondary | The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment) | over the whole duration of 58 weeks | |
| Secondary | The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58) | over 52 weeks | Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6. The absolute seizure frequency during the maintenance phase was defined as the sum of those entries. |
| Secondary | Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase | 52 weeks | |
| Secondary | QOLIE-31 (Quality Of Life In Epilepsy) Results at V6 | 58 weeks, final visit | The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry\*0.08 + overall quality of life\*0.14 + emotional well-being\*0.15 + energy/fatigue\*0.12 + cognitive functioning\*0.27 + medication effects\*0.03 + social functioning\*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100. |
| Secondary | Portland Neurotoxicity Scale (PNS) at V6 | at week 58 | The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items. Lower values indicate better quality of life. |
| Secondary | Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6 | week 58 | EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45. |
| Secondary | Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6 | 58 weeks | Evaluation of current testing at V6: ≥29 score points: Inconspicuous; 26 to 28 score points: Borderline; ≤25 score points: Impaired |
| Secondary | Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6) | week 58 | Evaluation of Changes Changes in the EpiTrack® Score were categorized as follows: ≥5 score points: Improved; -3 to 4 score points: Unchanged; ≤-4 score points: Worsened |
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/NCT00438451/registered