Sabril Patient Registry

July 28, 2016 updated by: Lundbeck LLC
The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with Sabril and the prescribers of Sabril.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective registry is part of the overall Risk Evaluation and Mitigation Strategy (REMS) required for Sabril by the United States Food and Drug Administration (FDA). All physicians who prescribe Sabril and all patients who take Sabril will be enrolled in a H. Lundbeck A/S-sponsored program called "SHARE" (Support, Help and Resources for Epilepsy), and the data that are collected and entered into the SHARE database will form the basis of this patient registry.

Prior to any prescription being filled by one of the specialty pharmacies, the prescribing physician and the patient must be enrolled in SHARE. A call center (SHARE Call Center) will act as the hub for a network of select specialty pharmacies. Participation in both SHARE and the patient registry is mandatory.

Information regarding prescriber specialty and location, patient demographic and disease characteristics will be collected through SHARE and entered into the database. Patients will be assigned a unique patient identifier upon entry into the registry, and all data related to that patient will be associated with this identifier.

Early in therapy (within 2-4 weeks for Infantile Spasms patients and 3 months for adult refractory Complex Partial Seizures patients), a mandatory benefit/risk assessment will occur. If the benefit of Sabril therapy exceeds the risk of vision loss, the prescribing physician will complete and submit the appropriate SHARE form and the patient will continue into the maintenance therapy phase of treatment. The outcome of this benefit/risk assessment will be entered into the database.

Regular assessments of vision are required during Sabril therapy to contribute information related to the ongoing benefit/risk assessments. The required assessments will occur at baseline, every 3 months during therapy, and about 3-6 months after stopping Sabril. The visual assessment results will be recorded and submitted using the appropriate SHARE forms, and the data will be entered into the database. A copy of the visual field will be included.

Patients will participate in the registry for as long as they receive Sabril therapy. Patients who discontinue treatment with Sabril, but are treated with it again at a later time will be treated as a single patient in the registry.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9423

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril. There are no other eligibility criteria for this study.

Description

Inclusion Criteria:

  • All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sabril®
All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril.
Drug: Sabril®

Infantile Spasms (IS): Initiate therapy at 50 mg/kg/day twice daily increasing total daily dose per instructions to a maximum of 150 mg/kg/day.

Refractory Complex Partial Seizures (rCPS) in Adults: Initiate therapy at 500 mg twice daily, increasing total daily dose per instructions. The recommended dose is 1.5 grams twice daily.

Other Names:
  • Vigabatrin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Characterize the prevalence, incidence, time to onset, progression, and severity of vision loss during Sabril treatment.
Time Frame: A yearly report
A yearly report

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Characterize the demographics, disease characteristics, dose and duration of therapy for patients who receive Sabril.
Time Frame: A yearly report
A yearly report
Characterize the physician specialties for prescribers of Sabril.
Time Frame: A yearly report
A yearly report

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lundbeck LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13101A
  • OV1040 (Other Identifier: Former study ID)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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