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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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19 February 2015 |
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Main ID: |
NCT00236756 |
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Date of registration:
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07/10/2005 |
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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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A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut Syndrome
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Scientific title:
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A Double-Blind Trial of Topiramate in Subjects With Lennox-Gastaut Syndrome. |
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Date of first enrolment:
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August 1993 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00236756 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Contacts
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Name:
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Body weight of at least 25 pounds
- diagnosis of Lennox-Gastaut syndrome and an electroencephalogram (EEG) with an
abnormal pulsation pattern
- atypical absence seizures and drop attacks (i.e., tonic-atonic seizures) among other
seizure types that could include tonic-clonic, myoclonic, and minor-motor
- at least 60 seizures during the month before baseline
- must be maintained on 1 or 2 antiepileptic drugs
- females must not have had their first menstrual period, or are physically incapable
of child bearing, or if of child bearing potential, sexually abstinent, or using
adequate contraceptive measures, and have a negative pregnancy test before study
entry.
Exclusion Criteria:
- Patients whose seizures are due to a progressive disease (for example, active
infection, cancer or metabolic disturbance)
- have a significant recent history (within 2 years) of medical diseases (respiratory,
heart, gastrointestinal, blood diseases, rheumatic fever or cancer)
- history of alcohol or drug abuse.
Age minimum:
12 Months
Age maximum:
30 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epilepsy
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Seizures
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Intervention(s)
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Drug: topiramate
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Primary Outcome(s)
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Percent reduction from baseline in seizure rates (all types of seizures) in the double-blind phase. Percent reduction in drop attacks (tonic-clonic) and parent/guardian global evaluation at end of study
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Secondary Outcome(s)
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Percent treatment responders all types of seizures. Percent treatment responders drop attacks (tonic-clonic seizures). Safety evaluations conducted throughout the study.
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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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