Trial · NCT00235755
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), DB Phase (Week 1 through Week 16) | Intent-to-Treat Food and Drug Administration (ITT FDA) Population: all randomized participants (P) who received at least 1 dose of study drug. Only participants with post-BL seizure data are included in this analysis. | percent change in seizure frequency | MEDIAN |
| PRIMARY | Number of Participants Classified as Responders and Non-responders During the Maintenance Phase | Week 5 through Week 16 | ITT European Medicines Evaluation Agency (EMEA) Population: all randomized participants who had received at least 1 dose of study drug in the Maintenance Phase and had at least 1 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 During the DB Phase | Week 1 through Week 16 | ITT FDA Population | 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 5 through Week 16 | ITT EMEA Population | 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 16 | ITT FDA Population | participants | NUMBER |
| SECONDARY | Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories | Baseline (Week -7 through Week 0), Week 1 through Week 16 | ITT FDA Population | 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 5 through Week 16 | ITT EMEA Population | 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 5 through Week 16 | ITT EMEA Population | 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 16 | ITT FDA Population | participants | NUMBER |
| SECONDARY | Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases) | Week 1 through Week 16 | ITT FDA Population. Only participants with post-baseline seizure data were included in the analysis. | participants | NUMBER |
| SECONDARY | Number of Participants Who Were Seizure-free During the Maintenance Phase | Week 5 through Week 16 | ITT EMEA Population | participants | NUMBER |
| SECONDARY | Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases) | Week 1 through Week 16 | ITT FDA Population. 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 5 through Week 16 | ITT EMEA Population | percentage of days | MEDIAN |
| SECONDARY | Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase | Week 16/end of treatment phase | ITT EMEA Population | scores on a scale | MEAN |
| SECONDARY | Patient Global Impression (PGI) Score at the End of the Maintenance Phase | Week 16/end of treatment phase | ITT EMEA Population. Only participants with post-baseline PGI scores were included in the analysis. | scores on a scale | MEAN |
| SECONDARY | Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) at BL (Week 0) and Weeks 4, 8, and 16 | End of Baseline (Week 0), Weeks 4, 8, and 16 | Safety Population: all randomized participants who received at least 1 dose of retigabine or placebo. Only participants with QOLIE-31-P data were included in the analysis. | 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 16 | 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 16 | Safety Population | participants | NUMBER |
| SECONDARY | Change From Baseline in Post-void Residual Urine Volume at Weeks 8 and 16 of the Maintenance Phase | Baseline (Week -7 through 0), Weeks 8 and 16 | 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 and 4 of theTitration Phase and Weeks 6, 8, 12, and 16 of the Maintenance Phase | Weeks 2 and 4 of Titration Phase and Weeks 6, 8, 12, and 16 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.
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GET https://conductscience.org/api/trials/v1/NCT00235755/outcomes