A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01278173|
Recruitment Status : Completed
First Posted : January 17, 2011
Results First Posted : June 7, 2016
Last Update Posted : June 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Adult Refractory Complex Partial Seizures||Drug: Sabril||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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®)|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Sabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
Other Name: Vigabatrin
- Mean 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 ]Mean change from the reference value in 30-2 SITA mean deviation, which was generated using the University of Iowa Visual Field Reading Center (VFRC) normative database and the Humphrey Field Analyzer (HFA) normative database. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). The mean change from the reference value are presented for Months 3, 6, 9 and 12. A negative change from the reference value indicates a decrease in the central visual field.
- Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography) [ Time Frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12 ]Mean change from the reference value in average RNFL thickness (µm) as measured by SD-OCT. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). Thinning of the RNFL, that is, a negative change from the reference value, has been associated with ophthalmological disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278173
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|