A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)
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®)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||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®)|
- Change from reference value in field width as measured by 30-2 SITA Fast in field sensitivity (Mean Deviation - MD in dB) [ Time Frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12 ] [ Designated as safety issue: Yes ]
- Change from reference value in average RNFL thickness (µm) as measured by SD-OCT [ Time Frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12 ] [ Designated as safety issue: Yes ]Potential changes in retinal function, as assessed by static perimetry, tangent corner test, visual acuity and color vision, during the first year of exposure to Sabril will be correlated with clinical changes in average retinal nerve fiber layer thickness (RNFL), as assessed by SD-OCT.
|Study Start Date:||December 2010|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Sabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
Other Name: Vigabatrin
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278173
Show 22 Study Locations
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|