Trial · NCT01060111

An Efficacy and Tolerability Study of Topiramate in Participants With Migraine

NCT01060111, Phase 4, Completed, Janssen Korea, Ltd., Korea; results first posted 2013-08-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Efficacy and Tolerability Study of Topiramate in Participants With Migraine. Trials, record NCT01060111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01060111

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Trial

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

Title: An Efficacy and Tolerability Study of Topiramate in Participants With Migraine
NCT number: NCT01060111
Status: Completed
Phases: Phase 4
Enrollment: 250 participants, actual
Lead sponsor: Janssen Korea, Ltd., Korea
Conditions: Migraine
Interventions: Topiramate Standard, Topiramate Slow, Propranolol booster
First posted: 2010-02-02
Last updated: 2013-08-22
Results first posted: 2013-08-06

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Percentage Decrease in Migraine Episodes	Maintenance period (Weeks 7 to 10)	Decrease in percentage of migraine frequency (episodes) was measured from baseline using a headache diary which is a typical scale measuring neuropsychiatric symptoms in a migraine participant. Migraine will be diagnosed in accordance with the guidelines of the International Headache Society (IHS).
Secondary	Change From Baseline in Migraine Frequency at Week 6	Baseline and Week 6	The migraine frequency at Week 6 was evaluated through a headache diary completed by a participant and the reduction rate of migraine frequency compared to the Baseline period was measured. Change values were calculated as Baseline value minus value at Week 6.
Secondary	Change From Baseline in Migraine Disability Assessment (MIDAS) Score at Week 6	Baseline and Week 6	MIDAS scoring ranges from 0 to 63. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability). Change values were calculated as Baseline value minus value at Week 6.
Secondary	Change From Baseline in Visual Analogue Scale (VAS) Score at Week 6	Baseline and Week 6	VAS was used to measure the intensity of migraine. The assessment scale ranges from 0 to 10. One end of the line drawn on the questionnaire is marked with 0 point indicating "no headache" and the other end with 10 points indicating "unimaginably strong headache." It means that the higher the score, the severe the pain is. Change values were calculated as Baseline value minus value at Week 6.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage Decrease in Migraine Episodes	Maintenance period (Weeks 7 to 10)	The intent-to-treat (ITT) population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'N' signifies participants who were evaluated for this outcome measure.	Percentage decrease in migraine episodes	MEAN
SECONDARY	Change From Baseline in Migraine Frequency at Week 6	Baseline and Week 6	The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.	Migraine episodes/Week	MEAN
SECONDARY	Change From Baseline in Migraine Disability Assessment (MIDAS) Score at Week 6	Baseline and Week 6	The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.	Units on a scale	MEAN
SECONDARY	Change From Baseline in Visual Analogue Scale (VAS) Score at Week 6	Baseline and Week 6	The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.	Units on a Scale	MEAN

Source ClinicalTrials.gov

Results by group21

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

Outcome	Group	Category	Value	Spread	Units
Percentage Decrease in Migraine Episodes	Topiramate Standard		48	Standard Deviation 69	Percentage decrease in migraine episodes
Percentage Decrease in Migraine Episodes	Topiramate Slow		57	Standard Deviation 48	Percentage decrease in migraine episodes
Percentage Decrease in Migraine Episodes	Topiramate Slow and Propranolol Booster		46	Standard Deviation 69	Percentage decrease in migraine episodes
Change From Baseline in Migraine Frequency at Week 6	Topiramate Standard	Baseline	1.48	Standard Deviation 0.76	Migraine episodes/Week
Change From Baseline in Migraine Frequency at Week 6	Topiramate Slow	Baseline	1.58	Standard Deviation 0.80	Migraine episodes/Week
Change From Baseline in Migraine Frequency at Week 6	Topiramate Slow and Propranolol Booster	Baseline	1.59	Standard Deviation 0.87	Migraine episodes/Week
Change From Baseline in Migraine Frequency at Week 6	Topiramate Standard	Change at Week 6 (n=51, 57, 43)	0.89	Standard Deviation 1.04	Migraine episodes/Week
Change From Baseline in Migraine Frequency at Week 6	Topiramate Slow	Change at Week 6 (n=51, 57, 43)	0.89	Standard Deviation 0.88	Migraine episodes/Week
Change From Baseline in Migraine Frequency at Week 6	Topiramate Slow and Propranolol Booster	Change at Week 6 (n=51, 57, 43)	0.74	Standard Deviation 1.31	Migraine episodes/Week
Change From Baseline in Migraine Disability Assessment (MIDAS) Score at Week 6	Topiramate Standard	Baseline	1.32	Standard Deviation 1.26	Units on a scale

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Topiramate Standard	81
Overall Study	STARTED	Topiramate Slow	84
Overall Study	STARTED	Topiramate Slow and Propranolol Booster	80
Overall Study	Treated	Topiramate Standard	81
Overall Study	Treated	Topiramate Slow	83
Overall Study	Treated	Topiramate Slow and Propranolol Booster	79
Overall Study	COMPLETED	Topiramate Standard	54
Overall Study	COMPLETED	Topiramate Slow	61
Overall Study	COMPLETED	Topiramate Slow and Propranolol Booster	45
Overall Study	NOT COMPLETED	Topiramate Standard	27

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events45

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	Paresthesia	Nervous system disorders	Topiramate Standard	42	81
other	Paresthesia	Nervous system disorders	Topiramate Slow	48	83
other	Paresthesia	Nervous system disorders	Topiramate Slow and Propranolol Booster	36	79
other	Dizziness	Nervous system disorders	Topiramate Standard	5	81
other	Dizziness	Nervous system disorders	Topiramate Slow	9	83
other	Dizziness	Nervous system disorders	Topiramate Slow and Propranolol Booster	14	79
other	Paraesthesia	Nervous system disorders	Topiramate Standard	6	81
other	Paraesthesia	Nervous system disorders	Topiramate Slow	5	83
other	Paraesthesia	Nervous system disorders	Topiramate Slow and Propranolol Booster	3	79
other	Somnolence	Nervous system disorders	Topiramate Standard	3	81

1 to 10 of 45Source ClinicalTrials.gov

See all 45 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Topiramate Standard
Total, all-cause mortality	Topiramate Slow
Total, all-cause mortality	Topiramate Slow and Propranolol Booster
Total, other adverse events	Topiramate Standard	62	81
Total, other adverse events	Topiramate Slow	62	83
Total, other adverse events	Topiramate Slow and Propranolol Booster	54	79
Total, serious adverse events	Topiramate Standard	0	81
Total, serious adverse events	Topiramate Slow	0	83
Total, serious adverse events	Topiramate Slow and Propranolol Booster	0	79

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.

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.

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