Sabril Patient Registry

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Brief Title

Sabril Patient Registry

Official Title

Sabril Patient Registry

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.
    


Study Type

Observational


Primary Outcome

Characterize the prevalence, incidence, time to onset, progression, and severity of vision loss during Sabril treatment.

Secondary Outcome

 Characterize the demographics, disease characteristics, dose and duration of therapy for patients who receive Sabril.

Condition

Infantile Spasms

Intervention

Sabril®

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

9423

Start Date

August 2009


Primary Completion Date

July 2016

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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Email contact via H. Lundbeck A/S, , 



Administrative Informations


NCT ID

NCT01073579

Organization ID

13101A

Secondary IDs

OV1040

Responsible Party

Sponsor

Study Sponsor

Lundbeck LLC


Study Sponsor

Email contact via H. Lundbeck A/S, Study Director, [email protected]


Verification Date

July 2016