Trial · NCT00567268
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 12 weeks | The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-Related Adverse Events | 12 weeks | The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. | participants | NUMBER |
| PRIMARY | Clinical Efficacy Rate | 12 weeks | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency within the safety analysis population. Participants who had disease not eligible for the survey were excluded from the efficacy analysis population. | Percentage of participants | NUMBER |
| SECONDARY | Response Ratio (R Ratio) | 12 weeks | R ratio analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population. | Ratio | MEAN |
| SECONDARY | Responder Rate | 12 weeks | Responder rate analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population. | Percentage of participants | NUMBER |
| SECONDARY | Percent Reduction From Baseline in Epileptic Seizure Frequency | 12 weeks | The analysis population comprised of the participants whose frequency of epileptic seizures during 4 weeks before gabapentin treatment (represented by B) was at least once within the R ratio analysis population. | Percentage | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories | 12 weeks | The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline | 12 weeks | The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years) | 12 weeks | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories | 12 weeks | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure | 12 weeks | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who who had diseases not eligible for the survey were excluded from the efficacy analysis population. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure | 12 weeks | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline | 12 weeks | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance | 12 weeks | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy | 12 weeks | The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population. | 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00567268/outcomes