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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 4

Conditions: Epilepsy

Treatments: Drug: Topiramate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01689649

TOP-VN -0107 (Other Identifier)

CR017830

TOPMATEPY4049 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is an open label (all people know the identity of the intervention), dose optimization trial to assess the tolerability and efficacy of topiramate as monotherapy in recently (within 5 years) diagnosed patients with epilepsy. Treatment naive patients (patients who have never received the treatment before) and patients who failed on their first AED in monotherapy are allowed. Failure is defined as a lack of efficacy and/or tolerability of that AED and the reason for failure is recorded by the physician. A lack of efficacy is characterized when the patient has been treated with AED at target dose but the patient still has seizure. Topiramate will first be titrated up to an initial target dose that will be reached after 4-6 weeks. Further dose titration is guided by the clinical response of the individual patient, but the dose may not exceed a maximum of 400mg/day [9mg/kg/day for children]. If the patient uses an AED at entry, the AED will be fully tapered off over a period of 3 weeks, starting at the beginning of week 2, in order to have all patients on topiramate monotherapy at visit 3. Tapering the AED off may, however, extend this 3-week period if clinically indicated. Visits will be performed at baseline and after 2, 4, 8, 12, 16 weeks. The total duration for each patient in the study will be 4 months.

Enrollment: 139 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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139 participants in 1 patient group

Topiramate

Experimental group

Description:

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.

Treatment:

Drug: Topiramate