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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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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2010-022655-29-NL |
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Date of registration:
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22/10/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Randomised open label cross-over study into the efficacy of RApamycin in children with Tuberous sclerosis complex with intractable Epilepsy (RATE-trial)
- RATE
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Scientific title:
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Randomised open label cross-over study into the efficacy of RApamycin in children with Tuberous sclerosis complex with intractable Epilepsy (RATE-trial)
- RATE |
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Date of first enrolment:
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30/05/2011 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022655-29 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: standard treatment
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Children with definite TSC older than 3 months, up to 12 yrs old, with catastrophic epilepsy (West syndrome or intractable epilepsy defined as 1 or more seizures/week despite two adequate trials of anti-epileptic drug regimens).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Renal dysfunction, surgery during 6wk before inclusion, current infection.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Epilepsy in children with Tuberous Sclerosis Complex
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Intervention(s)
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Trade Name: Rapamune
Pharmaceutical Form: Oral solution
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Primary Outcome(s)
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Main Objective: To evaluate the efficacy of rapamycin (Sirolimus) on intractable epilepsy in children with Tuberous Sclerosis Complex.
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Primary end point(s): Seizure frequency during the last month of treatment versus baseline (percentage change).
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Secondary Objective: To evaluate tolerability of rapamycin (Sirolimus) in children with TSC.
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Secondary ID(s)
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RATE-trial
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Source(s) of Monetary Support
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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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