Adult Refractory Complex Partial Seizures Clinical Trial
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®)
| Verified date | June 2015 |
| Source | Lundbeck LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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®)
| Status | Completed |
| Enrollment | 65 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Important Inclusion Criteria: 1. The patient speaks English or Spanish. 2. The patient has had no prior exposure to Sabril. 3. To begin Sabril therapy for the treatment of CPS. 4. Male or female =18 years of age. 5. The patient has refractory CPS: 1. The patient has complex partial epilepsy of more than 1 year duration and no other seizure type within the past year except for partial seizures secondarily generalized. 2. The patient has failed because of lack of efficacy 3 or more prior or concurrent treatment trials including 3 or more anti-epileptic drugs (AEDs) of differing pharmacologic mechanisms administered as monotherapy or polytherapy. 3. The patient is taking at least 1 AED. A vagal nerve stimulator is not counted as an AED. 4. The patient reports an average of 2 or more seizures per month averaged over the prior 3 months. 6. The patient is deemed by the treating neurologist and ophthalmologist to be able to reliably complete perimetry testing. 7. The initial (Visit 1) SD-OCT and static perimetry readings tests must be performed and assessed for technical adequacy by the SD-OCT and perimetry central readers prior to the first dose of Sabril. The initial (Visit 1) tangent corner test must be performed prior to the first dose of Sabril. Exclusion Criteria: 1. Prior exposure to Sabril. 2. 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. 3. Concurrent exposure to medications with known or suspected retinal or optic nerve toxicity. 4. Concurrent use of an investigational agent or device or such use within 30 days of entering the study. 5. Concurrent use of the ketogenic or similar diet. 6. For any reason, the patient is considered by the investigator to be an unsuitable candidate for the study. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Peachtree Neurological Clinic | Atlanta | Georgia |
| United States | Idaho Comprehensive Epilepsy Center | Boise | Idaho |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Neuroscience & Spine Institute | Charlotte | North Carolina |
| United States | CNMRI | Dover | Delaware |
| United States | Aurora BayCare Medical Center | Green Bay | Wisconsin |
| United States | Sunrise Clinical Research Group | Hollywood | Florida |
| United States | University of Texas | Houston | Texas |
| United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | University of Kentucky Lexington | Lexington | Kentucky |
| United States | Covenant Medical Group | Lubbock | Texas |
| United States | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin |
| United States | Yale Medical Center | New Haven | Connecticut |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Columbia University Medical Center | New York | New York |
| United States | OSF Saint Francis Medical Center | Peoria | Illinois |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | University of Texas Health Science Center | San Antonio | Texas |
| United States | California Pacific Medical Center | San Francisco | California |
| United States | Minnesota Epilepsy Group, PA | St. Paul | Minnesota |
| United States | University of South Florida | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Lundbeck LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from reference value in field width as measured by 30-2 SITA Fast in field sensitivity (Mean Deviation - MD in dB) | Baseline (Month 0), Month 3, Month 6, Month 9, Month 12 | Yes | |
| Primary | Change from reference value in average RNFL thickness (µm) as measured by SD-OCT | 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. | Baseline (Month 0), Month 3, Month 6, Month 9, Month 12 | Yes |