Trial · NCT01627860

First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients

NCT01627860, Phase 4, Completed, Johnson & Johnson Taiwan Ltd; results first posted 2013-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients. Trials, record NCT01627860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01627860

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients
NCT number: NCT01627860
Status: Completed
Phases: Phase 4
Enrollment: 55 participants, actual
Lead sponsor: Johnson & Johnson Taiwan Ltd
Conditions: Epilepsy
Interventions: Topiramate add-on therapy, Topiramate monotherapy
First posted: 2012-06-26
Last updated: 2013-10-29
Results first posted: 2013-05-24
Limitations and caveats: No limitations were reported in this study.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).	Month 4
Secondary	Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4	Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4	Seizure frequency (seizure count/month) was calculated based on the number of seizure within a month. The mean seizure frequency analyzed by the ANCOVA model at each period.
Secondary	Dosage Administration of Topamax During Month 4	Month 4

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).	Month 4	Intent-To-Treat population: All randomized participants who received at least one dose of study medication.	Percentage of participants	NUMBER
SECONDARY	Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4	Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4	Intent-To-Treat population: All randomized participants who received at least one dose of study medication.	Percent change	MEAN
SECONDARY	Dosage Administration of Topamax During Month 4	Month 4	Participants who have received study medication during month 4.	mg	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).	Topiramate Monotherapy	88.57	68.78 to 97.45	Percentage of participants
Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).	Topiramate add-on Therapy	65.00	49.20 to 95.34	Percentage of participants
Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4	Topiramate Monotherapy	-55.3	Standard Deviation 160	Percent change
Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4	Topiramate add-on Therapy	-75.8	Standard Deviation 54.1	Percent change
Dosage Administration of Topamax During Month 4	Topiramate Monotherapy	182.46	Standard Deviation 35.63	mg
Dosage Administration of Topamax During Month 4	Topiramate add-on Therapy	178.57	Standard Deviation 41.98	mg

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Topiramate Monotherapy	35
Overall Study	STARTED	Topiramate add-on Therapy	20
Overall Study	COMPLETED	Topiramate Monotherapy	23
Overall Study	COMPLETED	Topiramate add-on Therapy	14
Overall Study	NOT COMPLETED	Topiramate Monotherapy	12
Overall Study	NOT COMPLETED	Topiramate add-on Therapy	6

Source ClinicalTrials.gov

Adverse events34

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
other	Dizziness	Nervous system disorders	Topiramate Monotherapy	10	35
other	Dizziness	Nervous system disorders	Topiramate add-on Therapy	4	20
other	Headache	Nervous system disorders	Topiramate Monotherapy	6	35
other	Headache	Nervous system disorders	Topiramate add-on Therapy	3	20
other	Hypoaesthesia	Nervous system disorders	Topiramate Monotherapy	8	35
other	Hypoaesthesia	Nervous system disorders	Topiramate add-on Therapy	1	20
other	Decreased appetite	Gastrointestinal disorders	Topiramate Monotherapy	5	35
other	Decreased appetite	Gastrointestinal disorders	Topiramate add-on Therapy	1	20
other	Somnolence	Nervous system disorders	Topiramate Monotherapy	4	35
other	Somnolence	Nervous system disorders	Topiramate add-on Therapy	2	20

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Topiramate Monotherapy
Total, all-cause mortality	Topiramate add-on Therapy
Total, other adverse events	Topiramate Monotherapy	33	35
Total, other adverse events	Topiramate add-on Therapy	20	20
Total, serious adverse events	Topiramate Monotherapy	1	35
Total, serious adverse events	Topiramate add-on Therapy	1	20

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Topiramate Monotherapy vs Topiramate add-on Therapy: serious adverse events

Source Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01627860

GET https://conductscience.org/api/trials/v1/NCT01627860/events?page=2

API reference For AI assistants