Clinical trial NCT01073579: Sabril Patient Registry
Official title: Sabril Patient Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infantile Spasms
Refractory Complex Partial Seizures in Adults
Keywords: 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
Lead sponsor: Lundbeck LLC
Sponsor class: INDUSTRY
First posted: 2010-02-23
Enrollment: 9423
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Characterize the prevalence, incidence, time to onset, progression, and severity of vision loss during Sabril treatment.
timeFrame: A yearly report
Secondary outcomes:
measure: Characterize the demographics, disease characteristics, dose and duration of therapy for patients who receive Sabril.
timeFrame: A yearly report
measure: Characterize the physician specialties for prescribers of Sabril.
timeFrame: A yearly report
Other outcomes:
Locations:
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: