Trial · NCT01689649
A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy
NCT01689649, Phase 4, Completed, Janssen Research & Development, LLC; results first posted 2012-11-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy. Trials, record NCT01689649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01689649
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy
- NCT number
- NCT01689649
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 139 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Epilepsy
- Interventions
- Topiramate
- First posted
- 2012-09-21
- Last updated
- 2024-11-19
- Results first posted
- 2012-11-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment | Month 1, Month 3 and Month 4 | |
| Primary | Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment | Month 1, Month 3 and Month 4 | |
| Primary | Percentage of Seizure Free Participants During the Last 4 Months of Treatment | Month 1, Month 3 and Month 4 | |
| Secondary | Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks | Month 1, Month 3 and Month 4 | |
| Secondary | Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Frequency (Less Than 4, 4 to 10 and Greater Than 10) After 16 Weeks | Month 4 | |
| Secondary | General Clinical Assessment Before and After Treatment | Baseline (Day 0) and Month 4 | The general clinical assessment is measured by clinical global impression scale. The scale is used to grade the participants as very good, good, fairly good, medium and Poor before (Visit 1) and after treatment (Visit 6). |
| Secondary | Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment | Month 4 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment | Month 1, Month 3 and Month 4 | percentage of participants | NUMBER | |
| PRIMARY | Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment | Month 1, Month 3 and Month 4 | percentage of participants | NUMBER | |
| PRIMARY | Percentage of Seizure Free Participants During the Last 4 Months of Treatment | Month 1, Month 3 and Month 4 | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks | Month 1, Month 3 and Month 4 | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Frequency (Less Than 4, 4 to 10 and Greater Than 10) After 16 Weeks | Month 4 | percentage of participants | NUMBER | |
| SECONDARY | General Clinical Assessment Before and After Treatment | Baseline (Day 0) and Month 4 | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment | Month 4 | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment | Topiramate | Month 1 | 7.0 | percentage of participants | |
| Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment | Topiramate | Month 3 | 2.4 | percentage of participants | |
| Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment | Topiramate | Month 4 | 3.0 | percentage of participants | |
| Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment | Topiramate | Month 1 | 20.3 | percentage of participants | |
| Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment | Topiramate | Month 3 | 16.9 | percentage of participants | |
| Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment | Topiramate | Month 4 | 16.0 | percentage of participants | |
| Percentage of Seizure Free Participants During the Last 4 Months of Treatment | Topiramate | Month 1 | 58.6 | percentage of participants | |
| Percentage of Seizure Free Participants During the Last 4 Months of Treatment | Topiramate | Month 3 | 67.0 | percentage of participants | |
| Percentage of Seizure Free Participants During the Last 4 Months of Treatment | Topiramate | Month 4 | 70.0 | percentage of participants | |
Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks | Topiramate | Partial seizures with ≥50% | 3.0 | percentage of participants |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topiramate | 139 | |
| Overall Study | COMPLETED | Topiramate | 117 | |
| Overall Study | NOT COMPLETED | Topiramate | 22 |
Source ClinicalTrials.gov
Adverse events15
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 | Fever | General disorders | Topiramate | 10 | 132 | |
| other | Weight loss | General disorders | Topiramate | 30 | 132 | |
| other | Anorexia | General disorders | Topiramate | 16 | 132 | |
| other | Mood disorder | Psychiatric disorders | Topiramate | 3 | 132 | |
| other | Attention disorder | Psychiatric disorders | Topiramate | 3 | 132 | |
| other | Infection | Infections and infestations | Topiramate | 8 | 132 | |
| other | Sleep disorder | Psychiatric disorders | Topiramate | 4 | 132 | |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Topiramate | 10 | 132 | |
| other | Fatigue | General disorders | Topiramate | 8 | 132 | |
| other | Headache | Nervous system disorders | Topiramate | 5 | 132 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse 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 | 57 | 132 |
| Total, serious adverse events | Topiramate | 0 | 132 |
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/NCT01689649
GET https://conductscience.org/api/trials/v1/NCT01689649/results?page=2