Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201110000335351 Date of Registration: 27/10/2011
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of P-glycoprotein inhibitor in children with interactable epilepsy [retrospectively registered]
Official scientific title Role of P-glycoprotein inhibitor in children with interactable epilepsy
Brief summary describing the background and objectives of the trial The aim of this work is to measure the serum level of P-Glycoprotein in patients with intractable epilepsy & to assess the efficacy of Verapamil (as a P-Glycoprotein inhibitor) in those patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied intractable epilepsy,Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 19/10/2011
Actual trial start date 19/10/2011
Anticipated date of last follow up 07/04/2013
Actual Last follow-up date 07/04/2013
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group verapamil - Placebo 1 - 1.5 mg/kg/day bid one year P glycoprotein inhibitor - Calcium channel blocker 24 Placebo
Control Group Control - non investigational meds depending on participant one year my control group will not receive the investigated medication, the group will consist of medically controlled epileptic children, a blood sample will be withdrawn to measure P-glycoprotein level 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 5 Year(s) 15 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/07/2010 prof Dr Fathy Taash Head of medical ethics committee
Ethics Committee Address
Street address City Postal code Country
Lotfy Elsayed cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improved seizure control seizure severity will be evaluated every 3 months on Chalfont severity scale After one year P-glycoprotein will be re-measured (ELISA)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Children hospital Ain shams university Lotfy El-sayed Al-Abassya Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded s1 elshahied sayed zakaria cairo 11361 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor yasmin galal s1 elshahied sayed zakaria cairo 11361 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof Dr Hamed El-khayat othman ebn afan cairo Egypt
Dr Rasha Hussein Lotfy El-sayed Al-Abassya cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator yasmin galal dr_juse@yahoo.com +201222154587 s1 elshahied saied zakaria
City Postal code Country Position/Affiliation
cairo 11361 Egypt medical doctor
Role Name Email Phone Street address
Public Enquiries rasha hussein rashahusseinaly@yahoo.com +201223220859 lotfy elsayed
City Postal code Country Position/Affiliation
cairo Egypt Ass. professor - medical school Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Yasmin Galal dr_juse@yahoo.com +201222154587 s1 elshahied saied zakaria
City Postal code Country Position/Affiliation
Cairo 11361 Egypt Medical Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information