Sabril Patient Registry

• ClinicalTrials.gov Identifier: NCT01073579
• Recruitment Status: Completed
• First Posted: February 23, 2010
• Last Update Posted: July 29, 2016
• Sponsor: Lundbeck LLC
• Information provided by (Responsible Party): Lundbeck LLC

Study Description

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.

Study Design

• 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

Groups and Cohorts

Group/Cohort	Intervention/treatment
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 Name: Vigabatrin

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Criteria

Inclusion Criteria:

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

Contacts and Locations

Sponsors and Collaborators

Lundbeck LLC

Investigators

• Study Director: Email contact via H. Lundbeck A/S; LundbeckClinicalTrials@lundbeck.com

More Information

• Responsible Party: Lundbeck LLC
• ClinicalTrials.gov Identifier: NCT01073579
• Other Study ID Numbers: 13101A; OV1040 ( Other Identifier: Former study ID )
• First Posted: February 23, 2010
• Last Update Posted: July 29, 2016
• Last Verified: July 2016

Keywords provided by Lundbeck LLC:

Cryptogenic Infantile Spasms; Cryptogenic West Syndrome; Hypsarrhythmia; 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:

Seizures; Spasm; Spasms, Infantile; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neuromuscular Manifestations; Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Epileptic Syndromes; Vigabatrin; Anticonvulsants; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; GABA Agents; Neurotransmitter Agents; Physiological Effects of Drugs