Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 22, 2010
March 19, 2014
August 2009
August 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01073579 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Sabril Patient Registry
Sabril Patient Registry

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Infantile Spasms
  • Refractory Complex Partial Seizures in Adults
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
Sabril®
All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril.
Intervention: Drug: Sabril®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
15000
Not Provided
August 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients in the U.S. who are prescribed Sabril must participate in this patient registry in order to receive Sabril.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01073579
13101A, OV1040
Yes
Lundbeck LLC
Lundbeck LLC
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
Lundbeck LLC
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP