Back to resultsA Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)
Primary Purpose
Adult Refractory Complex Partial Seizures
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sabril
Sponsored by
About this trial
This is an interventional supportive care trial for Adult Refractory Complex Partial Seizures focused on measuring Vigabatrin-associated vision change, Adult refractory complex partial seizures, CPS, Epilepsy, Seizures, Brain diseases, Central Nervous System Diseases, Nervous System Diseases, Neurologic Manifestations, Enzyme Inhibitors, GABA Agents
Eligibility Criteria
Important Inclusion Criteria:
- The patient speaks English or Spanish.
- The patient has had no prior exposure to Sabril.
- To begin Sabril therapy for the treatment of CPS.
- Male or female ≥18 years of age.
The patient has refractory CPS:
- 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.
- 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.
- The patient is taking at least 1 AED. A vagal nerve stimulator is not counted as an AED.
- The patient reports an average of 2 or more seizures per month averaged over the prior 3 months.
- The patient is deemed by the treating neurologist and ophthalmologist to be able to reliably complete perimetry testing.
- 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:
- 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.
Sites / Locations
- California Pacific Medical Center
- Yale Medical Center
- CNMRI
- Sunrise Clinical Research Group
- University of South Florida
- Peachtree Neurological Clinic
- Idaho Comprehensive Epilepsy Center
- OSF Saint Francis Medical Center
- University of Kentucky Lexington
- Ochsner Clinic Foundation
- Minnesota Epilepsy Group, PA
- Dartmouth-Hitchcock Medical Center
- Columbia University Medical Center
- Neuroscience & Spine Institute
- Oregon Health and Science University
- Thomas Jefferson University
- Medical University of South Carolina
- University of Texas
- Covenant Medical Group
- University of Texas Health Science Center
- Aurora BayCare Medical Center
- Aurora St. Luke's Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sabril
Arm Description
Outcomes
Primary Outcome Measures
Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB)
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)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01278173
Brief Title
A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lundbeck LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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®)
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Refractory Complex Partial Seizures
Keywords
Vigabatrin-associated vision change, Adult refractory complex partial seizures, CPS, Epilepsy, Seizures, Brain diseases, Central Nervous System Diseases, Nervous System Diseases, Neurologic Manifestations, Enzyme Inhibitors, GABA Agents
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sabril
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Sabril
Other Intervention Name(s)
Vigabatrin
Intervention Description
Sabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
Primary Outcome Measure Information:
Title
Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB)
Description
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.
Time Frame
Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
Title
Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography)
Description
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.
Time Frame
Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Important Inclusion Criteria:
The patient speaks English or Spanish.
The patient has had no prior exposure to Sabril.
To begin Sabril therapy for the treatment of CPS.
Male or female ≥18 years of age.
The patient has refractory CPS:
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.
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.
The patient is taking at least 1 AED. A vagal nerve stimulator is not counted as an AED.
The patient reports an average of 2 or more seizures per month averaged over the prior 3 months.
The patient is deemed by the treating neurologist and ophthalmologist to be able to reliably complete perimetry testing.
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Yale Medical Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
CNMRI
City
Dover
State/Province
Delaware
ZIP/Postal Code
19901
Country
United States
Facility Name
Sunrise Clinical Research Group
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021-2834
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Peachtree Neurological Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Idaho Comprehensive Epilepsy Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
University of Kentucky Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Minnesota Epilepsy Group, PA
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10087
Country
United States
Facility Name
Neuroscience & Spine Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Covenant Medical Group
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54308
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)
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