Trial · NCT01682681
An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy
NCT01682681, Completed, Janssen Korea, Ltd., Korea; results first posted 2013-08-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy. Trials, record NCT01682681. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01682681
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy
- NCT number
- NCT01682681
- Status
- Completed
- Enrollment
- 1,234 participants, actual
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Conditions
- Epilepsy
- Interventions
- Topiramate
- First posted
- 2012-09-11
- Last updated
- 2013-09-06
- Results first posted
- 2013-08-16
- Limitations and caveats
- The study design is single arm and open label, so bias could not be excluded in the subjective evaluation by Participants and Investigators.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Retained to Topiramate Treatment | Week 52 | Participants with long term retention of topiramate until 52 weeks were reported |
| Secondary | Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs) | Baseline up to Week 52 | Number of participants who received concomitant AEDs along with the topiramate were reported. |
| Secondary | Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy | Baseline up to Week 52 | Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported. |
| Secondary | Percentage of Participants Without Seizure | Baseline up to Week 52 | Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52. |
| Secondary | Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More | Week 52 | Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Retained to Topiramate Treatment | Week 52 | The full analysis set (FAS) population included all participants who met all the eligibility criteria. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs) | Baseline up to Week 52 | FAS population included all participants who met all the eligibility criteria. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy | Baseline up to Week 52 | FAS population included all participants who met all the eligibility criteria. | Participants | NUMBER |
| SECONDARY | Percentage of Participants Without Seizure | Baseline up to Week 52 | FAS population included all participants who met all the eligibility criteria. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More | Week 52 | FAS population included all participants who met all the eligibility criteria. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Retained to Topiramate Treatment | Topiramate | 71.56 | 95% Confidence Interval 68.95 to 73.99 | Percentage of participants | |
| Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs) | Topiramate | 749 | Participants | ||
| Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy | Topiramate | First Mono-therapy | 507 | 0 | Participants |
| Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy | Topiramate | Second Mono-therapy | 64 | Participants | |
| Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy | Topiramate | Add-on therapy | 661 | Participants | |
| Percentage of Participants Without Seizure | Topiramate | 40.50 | 95% Confidence Interval 37.76 to 43.24 | Percentage of participants | |
| Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More | Topiramate | 84.20 | 95% Confidence Interval 82.10 to 86.30 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topiramate | 1,234 | |
| Overall Study | Treated | Topiramate | 1,232 | |
| Overall Study | COMPLETED | Topiramate | 902 | |
| Overall Study | NOT COMPLETED | Topiramate | 332 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Paraesthesia | Nervous system disorders | Topiramate | 19 | 1,234 | |
| other | Weight decreased | Nervous system disorders | Topiramate | 16 | 1,234 | |
| serious | Decreased appetite | Metabolism and nutrition disorders | Topiramate | 1 | 1,234 | |
| serious | Duodenal ulcer perforation | Gastrointestinal disorders | Topiramate | 1 | 1,234 | |
| serious | Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Topiramate | 1 | 1,234 | |
| serious | Death | General disorders | Topiramate | 5 | 1,234 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topiramate | ||
| Total, other adverse events | Topiramate | 34 | 1,234 |
| Total, serious adverse events | Topiramate | 8 | 1,234 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01682681
GET https://conductscience.org/api/trials/v1/NCT01682681/registered