Trial record 1 of 22 for:    sabril
Previous Study | Return to List | Next Study

Sabril Patient Registry

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Lundbeck LLC
ClinicalTrials.gov Identifier:
NCT01073579
First received: February 22, 2010
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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 Intervention
Infantile Spasms
Refractory Complex Partial Seizures in Adults
Drug: Sabril®

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Sabril Patient Registry

Resource links provided by NLM:


Further study details as provided by Lundbeck LLC:

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

Secondary Outcome Measures:
  • Characterize the demographics, disease characteristics, dose and duration of therapy for patients who receive Sabril. [ Time Frame: A yearly report ] [ Designated as safety issue: No ]
  • Characterize the physician specialties for prescribers of Sabril. [ Time Frame: A yearly report ] [ Designated as safety issue: No ]

Estimated Enrollment: 15000
Study Start Date: August 2009
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073579

Sponsors and Collaborators
Lundbeck LLC
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: Lundbeck LLC
ClinicalTrials.gov Identifier: NCT01073579     History of Changes
Other Study ID Numbers: 13101A, OV1040
Study First Received: February 22, 2010
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration

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:
Vigabatrin
Seizures
Spasms, Infantile
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Epilepsy, Generalized
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014