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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Lundbeck LLC
Sponsor:
Information provided by (Responsible Party):
Lundbeck LLC
ClinicalTrials.gov Identifier:
NCT01278173
First received: January 14, 2011
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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®)


Condition Intervention Phase
Adult Refractory Complex Partial Seizures
Drug: Sabril
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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®)

Resource links provided by NLM:


Further study details as provided by Lundbeck LLC:

Primary Outcome Measures:
  • Change from reference value in field width as measured by 30-2 SITA Fast in field sensitivity (Mean Deviation - MD in dB) [ Time Frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12 ] [ Designated as safety issue: Yes ]
  • Change from reference value in average RNFL thickness (µm) as measured by SD-OCT [ Time Frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 80
Study Start Date: December 2010
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sabril Drug: Sabril
Sabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
Other Name: Vigabatrin

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278173

Contacts
Contact: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

  Hide Study Locations
Locations
United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Kenneth Laxer, MD    415-600-7880      
United States, Connecticut
Yale Medical Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Kamil Detyniecki, MD    203-785-4836      
United States, Delaware
CNMRI Recruiting
Dover, Delaware, United States, 19901
Contact: Robert Varipapa, MD    302-678-8100      
United States, Florida
Sunrise Clinical Research Group Recruiting
Hollywood, Florida, United States, 33021-2834
Contact: Damon Salzman, MD    954-981-3850      
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Selim Benbadis, MD    813-259-8577      
United States, Georgia
Peachtree Neurological Clinic Recruiting
Atlanta, Georgia, United States, 30309
Contact: Lawrence Seiden, MD    404-351-2270      
United States, Idaho
Idaho Comprehensive Epilepsy Center Recruiting
Boise, Idaho, United States, 83702
Contact: Robert T. Wechsler, M.D., Ph.D.    208-381-7353      
United States, Illinois
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Erhan Ergene, MD    309-624-8570      
United States, Kentucky
University of Kentucky Lexington Recruiting
Lexington, Kentucky, United States, 40536
Contact: Meriem Bensalem-Owen, MD    859-218-5050      
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: R. Eugene Ramsay, MD    504-842-3980      
United States, Minnesota
Minnesota Epilepsy Group, PA Recruiting
St. Paul, Minnesota, United States, 55102
Contact: Patricia Penovich, MD    651-241-5290      
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Barbara Jobst, MD    603-650-6118      
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10087
Contact: Carl Bazil, MD    212-305-1742      
United States, North Carolina
Neuroscience & Spine Institute Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Bruce Mayes, MD    704-446-1900      
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Martin Salinsky, MD    503-494-5682      
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Michael Sperling, MD    215-955-1234      
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Ekrem Kutluay, MD    843-792-3383      
United States, Texas
University of Texas Recruiting
Houston, Texas, United States, 77030
Contact: Jeremy Slater, MD    713-500-7117      
Covenant Medical Group Recruiting
Lubbock, Texas, United States, 79410
Contact: Kalarickal Oommen, MD    806-725-4115      
University of Texas Health Science Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Charles A Szabo    210-450-0527      
United States, Wisconsin
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54308
Contact: James Napier, MD    920-288-8100      
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: George Morris, MD    414-385-8780      
Sponsors and Collaborators
Lundbeck LLC
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: Lundbeck LLC
ClinicalTrials.gov Identifier: NCT01278173     History of Changes
Other Study ID Numbers: 13098A
Study First Received: January 14, 2011
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Lundbeck LLC:
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

Additional relevant MeSH terms:
Vigabatrin
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014