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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01266291 |
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Date of registration:
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22/12/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients
STARS |
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Scientific title:
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Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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1 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01266291 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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John Pollard, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pennsylvania |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The patient or patient's legally authorized representative must sign and date the
Institutional Review Board approved Informed Consent and HIPPA Authorization Form.
- Male and female patients 18+ years of age with a clinical diagnosis of Tuberous
Sclerosis who experience an average of at least three partial seizures every two
months, of which one must be a complex partial seizure
- Patient must be on at least one and a maximum of four AEDs. Patient must be on a
stable AED dose regimen for at least 30 days prior to screening. Neither a Vagal Nerve
Stimulator (VNS) nor the ketogenic diet will count as an AED
- In the investigator's opinion, the patient or caregiver must be able to keep a seizure
diary
- An MRI in the last 5 years, or willingness to undergo an MRI as part of the screening
process
Exclusion Criteria:
- Cause of patient's seizures is a neurologic disease that is not Tuberous Sclerosis
- Current, clinical diagnosis of a major depressive episode or suicidal ideation
- Patient is taking more than four concurrent AEDs. Note: VNS or ketogenic diet is
allowed and will not be counted in the four allowed AEDs
- Patient has a progressive CNS lesion confirmed by magnetic resonance imaging (MRI) or
computed tomography (CT) scan
- Patient is currently abusing drugs or alcohol
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Complex Partial Seizures
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Intervention(s)
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Drug: vigabatrin
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Primary Outcome(s)
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Number of Participants Safely Tolerating Sabril
[Time Frame: Outcome measures will be assessed at the initiation of Sabril (titration), and at three and five months after starting Sabril. After this time, the subjects will have completed the study.]
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Secondary Outcome(s)
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Number of Patients Who Become Seizure Free While Taking Sabril
[Time Frame: Seizure freedom will be assessed for the two month treatment phase of the study (months 4 and 5)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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