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

Completed · Phase 4

Conditions studied: Adult Refractory Complex Partial Seizures

In brief

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®)

Key facts

Study ID

NCT01278173

Run by

Lundbeck LLC

People needed

65

Starts

2010-12-01

Expected to finish

2015-05-01

Last updated by the study team

2016-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior exposure to Sabril.
• Pre-existing ocular or neurological disease that might affect bilateral visual fields or interfere with perimetry (e.g., aphakia, visually significant cataract, glaucoma, diabetes mellitus, ischemic optic neuropathy, multiple sclerosis). Patients with stable visual field defects from CNS lesions (e.g., epilepsy surgery more than 6 months prior to receiving Sabril) may be enrolled.
• Concurrent exposure to medications with known or suspected retinal or optic nerve toxicity.
• Concurrent use of an investigational agent or device or such use within 30 days of entering the study.
• Concurrent use of the ketogenic or similar diet.
• For any reason, the patient is considered by the investigator to be an unsuitable candidate for the study.

Where it is running

• California Pacific Medical Center — San Francisco, California, United States
• Yale Medical Center — New Haven, Connecticut, United States
• CNMRI — Dover, Delaware, United States
• Sunrise Clinical Research Group — Hollywood, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Peachtree Neurological Clinic — Atlanta, Georgia, United States
• Idaho Comprehensive Epilepsy Center — Boise, Idaho, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• University of Kentucky Lexington — Lexington, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Minnesota Epilepsy Group, PA — Saint Paul, Minnesota, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Columbia University Medical Center — New York, New York, United States
• Neuroscience & Spine Institute — Charlotte, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas — Houston, Texas, United States
• Covenant Medical Group — Lubbock, Texas, United States
• University of Texas Health Science Center — San Antonio, Texas, United States
• Aurora BayCare Medical Center — Green Bay, Wisconsin, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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