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

NCT01278173 | Completed Phase 4 Results

• 1 other identifier: 13098A
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 22

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®)

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (Month 0), Month 3, Month 6, Month 9, Month 12

• 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.

  Baseline (Month 0), Month 3, Month 6, Month 9, Month 12

Study Arms (1)

Sabril

OTHER

Drug: Sabril

Interventions

Sabril DRUG

Sabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.

Also known as: Vigabatrin

Sabril

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Lundbeck LLC: lead

Study Sites (22)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Yale Medical Center

New Haven, Connecticut, 06520, United States

Location

CNMRI

Dover, Delaware, 19901, United States

Location

Sunrise Clinical Research Group

Hollywood, Florida, 33021-2834, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Peachtree Neurological Clinic

Atlanta, Georgia, 30309, United States

Location

Idaho Comprehensive Epilepsy Center

Boise, Idaho, 83702, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

University of Kentucky Lexington

Lexington, Kentucky, 40536, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Minnesota Epilepsy Group, PA

Saint Paul, Minnesota, 55102, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Columbia University Medical Center

New York, New York, 10087, United States

Location

Neuroscience & Spine Institute

Charlotte, North Carolina, 28207, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas

Houston, Texas, 77030, United States

Location

Covenant Medical Group

Lubbock, Texas, 79410, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54308, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Seizures; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations

Interventions

Vigabatrin

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: H
• Organization: Lundbeck

LundbeckClinicalTrials@Lundbeck.com

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: December 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 7, 2016
• Results First Posted: June 7, 2016

Record last verified: 2016-04

Locations

US (22)