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Completed

NCT Number: NCT01682681

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

The purpose of this study is to evaluate the long-term retention rate of topiramate in participants with epilepsy (seizure disorder).

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Key information

Age range

2 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective (study following participants forward in time), observational (a clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes) and multi-center (when more than one hospital or medical school team work on a medical research study) study of topiramte in participants with epilesy. The study population will be all the epilepsy participants visiting outpatient study center over a period of two months. Topiramate will be administered as per Investigator's discretion for 52 weeks. Participants will visit the trial site for evaluation of endpoint at Baseline, Week 12, Week 26, and Week 52. Efficacy will primarily be evaluated by percentage of participants which will be retained to topiramate treatment uptil Week 52. Participants' safety will be monitored throughout the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with all type of epilepsy
  • Participants with more than 2 episodes of seizure during last 1 year
  • Participants who can comply with the visit schedule and are willing and able to complete evaluation procedures specified in the protocol during the treatment period
  • Female participants with child bearing potential and who use proper contraceptive methods during the study period

Exclusion criteria

  • Participants who have known hypersensitivity reaction or allergy to the study drug
  • Participants who have taken topiramate within the three months of study start
  • Participants who are determined not to be suitable for the clinical study participation by an Investigator's discretion
  • Pregnant and nursing female participants

Treatment and study plan

Topiramate

Drug

This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.

Primary outcomes

  1. Percentage of Participants Retained to Topiramate Treatment

    Time frame: Week 52

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

Secondary outcomes

  1. Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)

    Time frame: Baseline up to Week 52

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

  2. Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy

    Time frame: Baseline up to Week 52

    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.

  3. Percentage of Participants Without Seizure

    Time frame: Baseline up to Week 52

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

  4. Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More

    Time frame: Week 52

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

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

A Prospective, Observational, Multi-center Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 11, 2012
Registry last updated
Sep 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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