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Sabril Patient Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01073579
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : July 29, 2016
Information provided by (Responsible Party):
Lundbeck LLC

Brief Summary:
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.

Condition or disease Intervention/treatment
Infantile Spasms Refractory Complex Partial Seizures in Adults Drug: Sabril®

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.

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Study Type : Observational
Actual Enrollment : 9423 participants
Time Perspective: Prospective
Official Title: Sabril Patient Registry
Study Start Date : August 2009
Actual Primary Completion Date : July 2016

Group/Cohort Intervention/treatment
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 Name: Vigabatrin

Primary Outcome Measures :
  1. Characterize the prevalence, incidence, time to onset, progression, and severity of vision loss during Sabril treatment. [ Time Frame: A yearly report ]

Secondary Outcome Measures :
  1. Characterize the demographics, disease characteristics, dose and duration of therapy for patients who receive Sabril. [ Time Frame: A yearly report ]
  2. Characterize the physician specialties for prescribers of Sabril. [ Time Frame: A yearly report ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073579

Sponsors and Collaborators
Lundbeck LLC
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
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Responsible Party: Lundbeck LLC
ClinicalTrials.gov Identifier: NCT01073579    
Other Study ID Numbers: 13101A
OV1040 ( Other Identifier: Former study ID )
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Keywords provided by Lundbeck LLC:
Cryptogenic Infantile Spasms
Cryptogenic West Syndrome
Infantile Spasms
Symptomatic Infantile Spasms
Symptomatic West Syndrome
West Syndrome
Refractory Complex Partial Seizures
Complex Partial Epilepsy
Complex Partial Seizure Disorder
Cryptogenic Partial Complex Epilepsy
Disorder, Complex Partial Seizures
Epilepsy, Cryptogenic, Partial Complex
Epilepsy, Psychic Equivalent
Epilepsy, Psychomotor
Epilepsy, Symptomatic, Partial Complex
Partial Complex Epilepsy, Cryptogenic
Partial Complex Epilepsy, Symptomatic
Seizure Disorder, Complex Partial
Symptomatic Partial Complex Epilepsy
Additional relevant MeSH terms:
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Spasms, Infantile
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Manifestations
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Epileptic Syndromes
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs