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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Lundbeck LLC

ClinicalTrials.gov Identifier:

NCT01278173

First received: January 14, 2011

Last updated: April 28, 2016

Last verified: April 2016

History of Changes

Results First Received: April 28, 2016

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Supportive Care
Condition:	Adult Refractory Complex Partial Seizures
Intervention:	Drug: Sabril

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

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

Participant Flow: Overall Study

	Sabril
STARTED	65
COMPLETED	38
NOT COMPLETED	27
Lack of Efficacy	13
Adverse Event	8
Administrative or other reason	4
Protocol Violation	1
Withdrawal by Subject	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who took at least one dose of IMP.

Reporting Groups

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

Baseline Measures

	Sabril
Number of Participants [units: participants]	65
Age [units: years] Mean (Standard Deviation)	39.8 (12.3)
Gender [units: participants]
Female	28
Male	37
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0
Asian	2
Native Hawaiian or Other Pacific Islander	0
Black or African American	5
White	58
More than one race	0
Unknown or Not Reported	0
Region of Enrollment [units: participants]
United States	65

Outcome Measures

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1. Primary:

Mean 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 ]

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2. Primary:

Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography) [ Time Frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: H
Organization: Lundbeck
e-mail: LundbeckClinicalTrials@Lundbeck.com

Responsible Party:	Lundbeck LLC
ClinicalTrials.gov Identifier:	NCT01278173 History of Changes
Other Study ID Numbers:	13098A
Study First Received:	January 14, 2011
Results First Received:	April 28, 2016
Last Updated:	April 28, 2016
Health Authority:	United States: Food and Drug Administration

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