Trial · NCT00232596
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases) | Baseline (Week -7 through Week 0), Week 1 through Week 18 | Intent-to-Treat (ITT) Population for Food and Drug Administration (FDA) review: all randomized participants (par.) who received at least one dose of the study drug. Only par. with baseline and post-baseline measures were analyzed. Two par. in each treatment arm did not have post-baseline measures and were thus not included in this analysis. | percent change in seizure frequency | MEDIAN |
| PRIMARY | Number of Participants Who Were Responders and Non-responders in the Maintenance Phase | Week 7 through Week 18 | Intent-to-Treat (ITT) Population for European Medicines Agency (EMEA) review: all randomized participants who received at least one dose of study drug in the Maintenance Phase and had at least one seizure measurement (whether or not they had a seizure) recorded in the Maintenance Phase | participants | NUMBER |
| SECONDARY | Number of Participants Who Were Responders and Non-responders in the DB Phase | Week 1 through Week 18 | ITT Population for FDA review | participants | NUMBER |
| SECONDARY | Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase | Baseline (Week -7 through Week 0), Week 7 through Week 18 | ITT Population for EMEA review | percent change in seizure frequency | MEDIAN |
| SECONDARY | Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories | Baseline (Week -7 through Week 0), Week 1 through Week 18 | ITT Population for FDA review | participants | NUMBER |
| SECONDARY | Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories | Baseline (Week -7 through Week 0), Week 1 through Week 18 | ITT Population for FDA review | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase | Baseline (Week -7 through Week 0), Week 7 through Week 18 | ITT Population for EMEA review | participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase | Baseline (Week -7 through Week 0), Week 7 through Week 18 | ITT Population for EMEA review. | participants | NUMBER |
| SECONDARY | Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline | Baseline (Week -7 through Week 0), Week 1 through Week 18 | ITT Population for FDA review | participants | NUMBER |
| SECONDARY | Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases) | Week 1 through Week 18 | ITT Population for FDA review. Only participants who had post-baseline seizure data were included in the analysis. | participants | NUMBER |
| SECONDARY | Number of Participants Who Were Seizure-free During the Maintenance Phase | Week 7 through Week 18 | ITT Population for EMEA review | participants | NUMBER |
| SECONDARY | Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases) | Week 1 through Week 18 | ITT Population for FDA review. Only participants who had post-baseline seizure data were included in the analysis. | percentage of days | MEDIAN |
| SECONDARY | Percentage of Seizure-free Days During the Maintenance Phase | Week 7 through Week 18 | ITT Population for EMEA review | percentage of days | MEDIAN |
| SECONDARY | Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase | Week 18/end of treatment phase | ITT Population for EMEA review. Only participants who had CGI-I scores were analyzed. | scores on a scale | MEAN |
| SECONDARY | Patient Global Impression (PGI) Score at the End of the Maintenance Phase | Week 18/end of treatment phase | ITT Population for EMEA review. Only participants who had a PGI score were analyzed. | scores on a scale | MEAN |
| SECONDARY | Quality of Life (QOL) Assessed by QOL in Epilepsy-Problems Questionnaire (QOLIE-31-P) at Baseline (Week 0) and Weeks 6, 10, and 18 | End of Baseline (Week 0), Weeks 6, 10, and 18 | Safety Population: all randomized participants who received at least 1 dose of retigabine or placebo. Participants who were cognitively impaired and could not complete the QOLIE-31-P assessment were not analyzed. The number of participants analyzed differs by week because not all participants completed the questionnaire at the indicated weeks. | scores on a scale | MEAN |
| SECONDARY | Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm) | Week 1 through Week 24 | Safety Population | participants | NUMBER |
| SECONDARY | Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm) | Week 1 through Week 24 | Safety Population | participants | NUMBER |
| SECONDARY | Change From Baseline in Post-void Residual Urine Volume at Weeks 10 and 18 of the DB Treatment Phase | Baseline (Week -7 through Week 0), Weeks 10 and 18 | Safety Population. Only participants who remained in the study at the indicated week and who also had a PVR assessment were analyzed. | milliliters | MEDIAN |
| SECONDARY | Number of Participants With a >=7% Increase in Body Weight During Weeks 2, 4, and 6 of theTitration Phase and Weeks 7, 8, 10, 14, and 18 of the Maintenance Phase | Weeks 2, 4, 6 of Titration Phase and Weeks 7, 8, 10, 14, and 18 of Maintenance Phase | Safety Population. Only participants who remained in the study at the indicated week and who also had a body weight assessment were analyzed. | 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.
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GET https://conductscience.org/api/trials/v1/NCT00232596/outcomes