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Main
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Note: This record shows only the 20 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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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201110000335351 |
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Date of registration:
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27/10/2011 |
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Primary sponsor: |
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Public title:
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Role of P-glycoprotein inhibitor in children with interactable epilepsy [retrospectively registered]
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Scientific title:
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Role of P-glycoprotein inhibitor in children with interactable epilepsy |
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Date of first enrolment:
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2011-10-19 |
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Target sample size:
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20-30 |
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201110000335351 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Simple randomisation using by using procedures such as coin-tossing or dice-rolling,
sealed opaque envelopes,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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rasha
hussein |
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Address:
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lotfy elsayed
cairo
Egypt |
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Telephone:
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+201223220859 |
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Email:
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rashahusseinaly@yahoo.com |
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Affiliation:
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Ass. professor - medical school Ain shams university |
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Name:
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Yasmin
Galal |
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Address:
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s1 elshahied saied zakaria
11361
Cairo
Egypt |
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Telephone:
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+201222154587 |
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Email:
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dr_juse@yahoo.com |
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Affiliation:
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Medical Doctor |
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Key inclusion & exclusion criteria
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Inclusion criteria: Age 5 - 15 years old
Probable or definite localization-related, primary generalized or symptomatic generalized epilepsy that is medically-refractory, as defined by treatment failure of at least 2 anti-epilepsy drugs at standard doses, despite medication compliance as determined by the treating neurologist. Epileptic patients are considered controlled if they are seizure free for more than six months.
Ability of the patient or gaurdian to understand the concept of a placebo-controlled clinical trial
Exclusion criteria: Any patient with pre-existing cardiac condition.
Low blood pressure as regard to the patient age, below 25th percentiles
Known hypersensitivity to Verapamil or any component of the formulation.
Patient with co-existing renal or hepatic illness
Age minimum:
5 Year
Age maximum:
15 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epilepsy (Intractable)
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Primary Outcome(s)
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improved seizure control
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Source(s) of Monetary Support
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self funded
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