Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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8 August 2016 |
Main ID: |
NCT01073579 |
Date of registration:
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22/02/2010 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Sabril Patient Registry
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Scientific title:
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Sabril Patient Registry |
Date of first enrolment:
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August 2009 |
Target sample size:
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9423 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01073579 |
Study type:
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Observational |
Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Contacts
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Name:
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Email contact via H. Lundbeck A/S |
Address:
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Telephone:
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Email:
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Affiliation:
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LundbeckClinicalTrials@lundbeck.com |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients in the U.S. who are prescribed Sabril must participate in this patient
registry in order to receive Sabril.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Infantile Spasms
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Refractory Complex Partial Seizures in Adults
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Intervention(s)
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Drug: SabrilĀ®
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Primary Outcome(s)
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Characterize the prevalence, incidence, time to onset, progression, and severity of vision loss during Sabril treatment.
[Time Frame: A yearly report]
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Secondary Outcome(s)
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Characterize the physician specialties for prescribers of Sabril.
[Time Frame: A yearly report]
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Characterize the demographics, disease characteristics, dose and duration of therapy for patients who receive Sabril.
[Time Frame: A yearly report]
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Secondary ID(s)
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13101A
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OV1040
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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