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

NCT01682681 | Completed Results DMC

• 2 other identifiers: CR015865TOPMATEPY4053
• Study Type: observational
• Target: 1,234
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Epilepsy

Keywords

Epilepsy; Topiramate; Topmax

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Retained to Topiramate Treatment

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

  Week 52

Secondary Outcomes (4)

• Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)

  Baseline up to Week 52

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

  Baseline up to Week 52

• Percentage of Participants Without Seizure

  Baseline up to Week 52

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

  Week 52

Study Arms (1)

Topiramate

Drug: Topiramate

Interventions

Topiramate DRUG

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

Topiramate

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants with epilepsy who visit an out-patient clinic for two months and have not received topiramate treatment for at least three months prior to Screening.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Epilepsy

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Limitations and Caveats

The study design is single arm and open label, so bias could not be excluded in the subjective evaluation by Participants and Investigators.

Results Point of Contact

• Title: Clinical Research Associate, Medical affairs
• Organization: Janssen Korea, Location: 25F, LS , Yongsan Tower, 191, Hankangro 2-Ga, Yongsan-Gu, Seoul 140-702, Korea

82-2-2094-4837

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: September 11, 2012
• Study Start: July 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 6, 2013
• Results First Posted: August 16, 2013

Record last verified: 2013-08