NCT01278173

A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)

A Prospective, Open-label Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Lundbeck LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the change in visual fields by means of automated static perimetry and to evaluate the change in retinal structure by means of spectral domain optical coherence tomography (SD-OCT) in adult patients with refractory complex partial seizures (CPS) being treated with vigabatrin (Sabril®)

Detailed description

Multicenter, prospective open-label study with approximately 25 sites in the US that specialize in caring for adult patients with refractory CPS * Sites must have access to Humphrey static perimetry and to Spectralis SD-OCT. * All vision test results will be sent to the central readers for evaluation. * Additional study tests: * The Columbia Suicide Severity Rating Scale (C-SSRS) * The National Eye Institute Visual Field Questionnaire-39 (NEI VFQ-39) * A whole blood sample for specific analysis of DNA characteristics * An optional whole blood sample for exploratory analysis of DNA characteristics * Plasma samples for bioanalytical analysis of vigabatrin and blood samples for taurine biomarker analysis

Conditions

• Adult Refractory Complex Partial Seizures

Interventions

Type	Name	Description
DRUG	Sabril	Sabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2011-01-17
• Last updated: 2016-06-07
• Results posted: 2016-06-07

Locations

22 sites across 1 country: United States