A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

Viatris

Status and phase: Completed; Phase 3

Conditions: Partial Onset Seizures

Treatments: Drug: Pregabalin Dose Level 1; Drug: Pregabalin Dose Level 2; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02072824

2013-003420-37 (EudraCT Number)

A0081042

Details and patient eligibility

About

This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.

Enrollment: 175 patients

Sex: All

Ages: 1 month to 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must have 3 partial onset seizures in the month prior to screening.
• Subject must have 2 partial onset seizures during the 48 hour baseline phase.
• Signed Informed Consent.
• On 1-3 stable anti-epileptic drugs at screening.

Exclusion criteria

• Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
• Lennox-Gasteau, BECTS, and Dravet's syndrome.
• Status epliepticus within 1 year of screening.
• Any change in AED regimen with 7 days of screening.
• Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.
• Progressive errors of metabolism.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

175 participants in 3 patient groups, including a placebo group

Study Drug Level 1

Experimental group

Treatment:

Drug: Pregabalin Dose Level 1

Study Drug Level 2

Experimental group

Treatment:

Drug: Pregabalin Dose Level 2

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo