A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy

NCT01689649 | Completed Phase 4 Results

• 3 other identifiers: CR017830TOPMATEPY4049TOP-VN -0107
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this dose optimization study is to assess tolerability and efficacy of topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive or have failed one anti-epileptic drug (AED) treatment in monotherapy.

Conditions

Epilepsy

Keywords

Epilepsy; Seizures; Topiramate; Anti-epileptic drug; Nervous disorder

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment

  Month 1, Month 3 and Month 4

• Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment

  Month 1, Month 3 and Month 4

• Percentage of Seizure Free Participants During the Last 4 Months of Treatment

  Month 1, Month 3 and Month 4

Secondary Outcomes (4)

• 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

  Month 1, Month 3 and Month 4

• 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

  Month 4

• General Clinical Assessment Before and After Treatment

  Baseline (Day 0) and Month 4

• Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment

  Month 4

Study Arms (1)

Topiramate

EXPERIMENTAL

For children: Children will start on topiramate with a dosage of 0.5mg/kg in the evening, followed by 0.5mg/kg/day weekly increments until an initial target dose of 3mg/kg/day is reached. The total daily topiramate dose for children may, not exceed 9mg/kg/day. For adult patients: Adult patients start on topiramate with a dosage of 25mg/day in the evening, followed by weekly increments of 25 mg/day until an initial target dose of 100mg/day is reached. The dose of topiramate may be increased to the optimal dose with weekly increments of 0.5mg/kg/day and of 25 mg/day for children and adults, respectively at the discretion of the investigator.

Drug: Topiramate

Interventions

Topiramate DRUG

The patients will receive topiramate tablet twice daily orally up to 16 weeks.

Topiramate

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Has been diagnosed with epilepsy within the past 5 years with Primary Generalized Tonic-Clonic (PGTC) seizures as well as partial onset seizures with or without secondary generalization
• Therapy naive, or being treated with their first anti-epileptic drug (AED) in monotherapy that fails in efficacy, tolerability, or both, and not in need of a combination AED therapy
• Informed Assent in children at least 7 years and older

You may not qualify if:

• Have pseudoseizures or the treatable cause of the seizures (eg, metabolic disorder, toxic exposure, active infection or neoplasia)
• Has any clinically relevant progressive or serious illness (eg, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric, or metabolic disturbance)
• Pregnant or breast-feeding
• Has a history or suspicion of alcohol or drug abuse
• Must have on current treatment with furosemide, hydrochlorothiazide, monoamine oxidase inhibitors

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Unknown Facility

Hanoi, Vietnam

Location

Unknown Facility

Hochiminh, Vietnam

Location

MeSH Terms

Conditions

Epilepsy; Seizures; Nervous System Diseases

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Medical Director
• Organization: Janssen-Cilag Taiwan

886 2 23762155

Study Officials

• Janssen-Cilag VIETNAM Clinical Trial

  Janssen-Cilag VIETNAM

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: September 21, 2012
• Study Start: May 2, 2008
• Primary Completion: January 19, 2010
• Study Completion: January 19, 2010
• Last Updated: November 19, 2024
• Results First Posted: November 21, 2012

Record last verified: 2024-10

Locations

VN (2)