Trial Outcomes & Findings for A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy (NCT NCT01689649)
NCT ID: NCT01689649
Last Updated: 2024-11-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
139 participants
Primary outcome timeframe
Month 1, Month 3 and Month 4
Results posted on
2024-11-19
Participant Flow
139 epileptic participants from three participating centers (Neurological department of the Central (Vietnam-Sweden) Pediatrics Hospital, Neurological department of Children's Hospital N0 II at Ho Chi Minh City and the Children's Outpatient Clinic of the Mental Hospital at Ho Chi Minh City) were enrolled in this study to receive topiramate.
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
Participant milestones
| Measure |
Topiramate
The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
|
|---|---|
|
Overall Study
STARTED
|
139
|
|
Overall Study
COMPLETED
|
117
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Topiramate
The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
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|---|---|
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Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Non-compliance
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11
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy
Baseline characteristics by cohort
| Measure |
Topiramate
n=139 Participants
The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
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|---|---|
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Age, Continuous
|
10.1 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 1, Month 3 and Month 4Outcome measures
| Measure |
Topiramate
n=139 Participants
The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
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|---|---|
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Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment
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
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
Month 4
|
3.0 percentage of participants
|
PRIMARY outcome
Timeframe: Month 1, Month 3 and Month 4Outcome measures
| Measure |
Topiramate
n=139 Participants
The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
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|---|---|
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Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment
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
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
Month 4
|
16.0 percentage of participants
|
PRIMARY outcome
Timeframe: Month 1, Month 3 and Month 4Outcome measures
| Measure |
Topiramate
n=139 Participants
The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
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|---|---|
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Percentage of Seizure Free Participants During the Last 4 Months of Treatment
Month 1
|
58.6 percentage of participants
|
|
Percentage of Seizure Free Participants During the Last 4 Months of Treatment
Month 3
|
67.0 percentage of participants
|
|
Percentage of Seizure Free Participants During the Last 4 Months of Treatment
Month 4
|
70.0 percentage of participants
|
SECONDARY outcome
Timeframe: Month 1, Month 3 and Month 4Outcome measures
| Measure |
Topiramate
n=139 Participants
The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
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|---|---|
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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
Partial seizures with ≥50%
|
3.0 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
Secondarily generalized seizure with ≥50%
|
3.3 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
Generalized tonic clonic seizure with ≥50%
|
2.0 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
Partial seizures with ≥75%
|
17.5 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
Secondarily generalized seizure with ≥75%
|
26.7 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
Generalized tonic clonic seizure with ≥75%
|
10.0 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
Partial seizures with 100%
|
65.0 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
Secondarily generalized seizure with 100%
|
60.0 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
Generalized tonic clonic seizure with 100%
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: Month 4Outcome measures
| Measure |
Topiramate
n=139 Participants
The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
|
|---|---|
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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
< 4 seizures/month with ≥50%
|
3.0 percentage of participants
|
|
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
< 4 seizures/month with ≥75%
|
5.7 percentage of participants
|
|
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
< 4 seizures/month 100%
|
74.3 percentage of participants
|
|
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
4-10 seizures/month with ≥50%
|
5.7 percentage of participants
|
|
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
4-10 seizures/month with ≥75%
|
11.0 percentage of participants
|
|
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
4-10 seizures/month with 100%
|
71.0 percentage of participants
|
|
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
>10 seizures/month with ≥50%
|
0.0 percentage of participants
|
|
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
>10 seizures/month with ≥75%
|
28.0 percentage of participants
|
|
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
>10 seizures/month with 100%
|
66.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Month 4The 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).
Outcome measures
| Measure |
Topiramate
n=139 Participants
The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
|
|---|---|
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General Clinical Assessment Before and After Treatment
Visit 6: Fairly good
|
25.2 percentage of participants
|
|
General Clinical Assessment Before and After Treatment
Visit 1: Very good
|
0.0 percentage of participants
|
|
General Clinical Assessment Before and After Treatment
Visit 6: Very good
|
17.9 percentage of participants
|
|
General Clinical Assessment Before and After Treatment
Visit 1: Good
|
1.4 percentage of participants
|
|
General Clinical Assessment Before and After Treatment
Visit 6: Good
|
52.8 percentage of participants
|
|
General Clinical Assessment Before and After Treatment
Visit 1: Fairly good
|
37.7 percentage of participants
|
|
General Clinical Assessment Before and After Treatment
Visit 1: Medium
|
44.9 percentage of participants
|
|
General Clinical Assessment Before and After Treatment
Visit 6: Medium
|
1.6 percentage of participants
|
|
General Clinical Assessment Before and After Treatment
Visit 1: Poor
|
15.9 percentage of participants
|
|
General Clinical Assessment Before and After Treatment
Visit 6: Poor
|
2.4 percentage of participants
|
SECONDARY outcome
Timeframe: Month 4Outcome measures
| Measure |
Topiramate
n=139 Participants
The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
|
|---|---|
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Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment
WIth previous treatment ≥50%
|
2.3 percentage of participants
|
|
Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment
WIth previous treatment ≥75%
|
11.4 percentage of participants
|
|
Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment
WIth previous treatment 100%
|
70.5 percentage of participants
|
|
Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment
WIthout previous treatment ≥50%
|
2.7 percentage of participants
|
|
Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment
WIthout previous treatment ≥75%
|
19.2 percentage of participants
|
|
Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment
WIthout previous treatment 100%
|
69.9 percentage of participants
|
Adverse Events
Topiramate
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Topiramate
n=132 participants at risk
The participants will receive an initial dose of 0.5mg/kg per oral (PO) in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
|
|---|---|
|
General disorders
Fever
|
7.6%
10/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
General disorders
Weight loss
|
22.7%
30/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
General disorders
Anorexia
|
12.1%
16/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
Psychiatric disorders
Mood disorder
|
2.3%
3/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
Psychiatric disorders
Attention disorder
|
2.3%
3/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
Infections and infestations
Infection
|
6.1%
8/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
Psychiatric disorders
Sleep disorder
|
3.0%
4/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
7.6%
10/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
General disorders
Fatigue
|
6.1%
8/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
Nervous system disorders
Headache
|
3.8%
5/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
Skin and subcutaneous tissue disorders
Itching
|
3.0%
4/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
Renal and urinary disorders
Urinary frequency
|
0.76%
1/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
Eye disorders
Conjunctivitis
|
0.76%
1/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
Psychiatric disorders
Irritability
|
1.5%
2/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
|
Nervous system disorders
Belly twitch
|
0.76%
1/132 • 16 weeks
Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.
|
Additional Information
Medical Director
Janssen-Cilag Taiwan
Phone: 886 2 23762155
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place