At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 65 enrolled
Drug / intervention
Sabrildrug
Likely dose
Sabril 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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®)
In Brief
A Phase 4 clinical trial evaluating Sabril for Adult Refractory Complex Partial Seizures. Completed, enrolled 65 participants across 22 sites.
Detailed 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®)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2010
First PostedJan 2011
Primary CompletionMay 2015
TodayJul 2026
First PostedJan 17, 2011
Enrollment StartDec 1, 2010
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 15.5 years ago
Interventions
Sabrildrug
Sabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.