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Sponsor study identifier
interventional
10
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Objective: To test the hypothesis that 6 months treatment with glatiramer acetate (GA) decreases epileptiform activity in young girls with Rett syndrome. Primary Safety Objective:To evaluate the safety and tolerability of 6 months treatment with GA in these patients. Secondary Objectives:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 23, 2013
Actual (reported)December 30, 2013
Actual (reported)January 2014
Date type not reportedThis date has not been verified as actual or estimated.
September 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Improvement of epileptiform activity as recorded in a 24-hours EEG.
6 months
1.Improvement in the scoring of breath holds and hyperventilation, as measured with non-invasive respiratory inductance plethysmography (NoxT3 device) and parents' diaries.
8 months
2. Changes in general behaviour, communication, feeding and motor skills as assessed by the investigator (based on Kerr and Naidu validated severity scores) and recorded in parents' diary.
8 months
Decrease in seizure frequency as reported in parents' diary.
8 months
Improvement in sleep schedule as recorded in a sleep diary.
8 months
Change in height and weight
8 months
Glatiramer Acetate (Copaxone® , Teva Pharmaceutical Industries Ltd.) 20 mg daily or in an interval determined in the Dose Setting period. Administration will be subcutaneous to various areas on the body: back of the upper arms (2 areas), front and outside of thighs (2 areas), upper buttocks/rear hips (2 areas), and stomach (the abdomen).
GA is a potent inducer of Th2-cells and modulates these immune cells to secrete high levels of neurotrophic factors, particularly BDNF. The induced cells cross the blood brain barrier (BBB), accumulate in the CNS and express BDNF and other regulatory substances in situ.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sheba Medical Center
Ramat Gan, Israel
Bruria Ben Zeev, prof.
Sheba Medical Center
Andreea Nissenkorn, Dr.
Sheba Medical Center
Irit Avisar, R.N M.A
Sheba Medical Center
First Submitted
December 23, 2013
First Posted
December 30, 2013
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 4, 2014
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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