Trial Outcomes & Findings for An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy (NCT NCT01682681)

NCT ID: NCT01682681

Last Updated: 2013-09-06

Results Overview

Participants with long term retention of topiramate until 52 weeks were reported

• Recruitment status: COMPLETED
• Target enrollment: 1234 participants
• Primary outcome timeframe: Week 52
• Results posted on: 2013-09-06

Participant Flow

Participant milestones

Measure	Topiramate This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
Overall Study STARTED	1234
Overall Study Treated	1232
Overall Study COMPLETED	902
Overall Study NOT COMPLETED	332

Reasons for withdrawal

Measure	Topiramate This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
Overall Study Lack of Efficacy	62
Overall Study Withdrawal by Subject	1
Overall Study Moved to other hospital	10
Overall Study Lost to Follow-up	174
Overall Study Adverse Event	46
Overall Study tapering of topiramate	5
Overall Study Other	21
Overall Study Low compliance	13

Baseline Characteristics

An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy

Baseline characteristics by cohort

Measure	Topiramate n=1232 Participants This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
Age Continuous	24.07 Years STANDARD_DEVIATION 17.10 • n=5 Participants
Sex: Female, Male Female	562 Participants n=5 Participants
Sex: Female, Male Male	670 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52

Population: The full analysis set (FAS) population included all participants who met all the eligibility criteria.

Participants with long term retention of topiramate until 52 weeks were reported

Outcome measures

Measure	Topiramate n=1232 Participants This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
Percentage of Participants Retained to Topiramate Treatment	71.56 Percentage of participants Interval 68.95 to 73.99

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: FAS population included all participants who met all the eligibility criteria.

Number of participants who received concomitant AEDs along with the topiramate were reported.

Outcome measures

Measure	Topiramate n=1232 Participants This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)	749 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: FAS population included all participants who met all the eligibility criteria.

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.

Outcome measures

Measure	Topiramate n=1232 Participants This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy First Mono-therapy	507 Participants 0
Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy Second Mono-therapy	64 Participants
Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy Add-on therapy	661 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: FAS population included all participants who met all the eligibility criteria.

Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.

Outcome measures

Measure	Topiramate n=1232 Participants This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
Percentage of Participants Without Seizure	40.50 Percentage of participants Interval 37.76 to 43.24

SECONDARY outcome

Timeframe: Week 52

Population: FAS population included all participants who met all the eligibility criteria.

Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.

Outcome measures

Measure	Topiramate n=1232 Participants This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More	84.20 Percentage of participants Interval 82.1 to 86.3

Adverse Events

Topiramate

Serious events: 8 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	Topiramate n=1234 participants at risk This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
Metabolism and nutrition disorders Decreased appetite	0.08% 1/1234 • Baseline up to Week 52
Gastrointestinal disorders Duodenal ulcer perforation	0.08% 1/1234 • Baseline up to Week 52
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.08% 1/1234 • Baseline up to Week 52
General disorders Death	0.41% 5/1234 • Baseline up to Week 52

Other adverse events

Measure	Topiramate n=1234 participants at risk This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.
Nervous system disorders Paraesthesia	1.5% 19/1234 • Baseline up to Week 52
Nervous system disorders Weight decreased	1.3% 16/1234 • Baseline up to Week 52

Additional Information

Clinical Research Associate, Medical affairs

Janssen Korea, Location: 25F, LS , Yongsan Tower, 191, Hankangro 2-Ga, Yongsan-Gu, Seoul 140-702, Korea

Phone: 82-2-2094-4837

Results disclosure agreements

• Principal investigator is a sponsor employee PI cannot provide any trial related information to external parties' without mutual agreement with the Sponsor. This is valid even after the contract is canceled.
• Publication restrictions are in place

Restriction type: OTHER