Trial of Dextromethorphan in Rett Syndrome
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|ClinicalTrials.gov Identifier: NCT00593957|
Recruitment Status : Terminated (Study changed to a placebo controlled trial of dextromethorphan)
First Posted : January 15, 2008
Results First Posted : April 23, 2014
Last Update Posted : April 23, 2014
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Information provided by (Responsible Party):
SakkuBai Naidu, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment|
|Recruitment Details||Recruitment was from 2004 to 2010. Study initiation was delayed due to the closure of Johns Hopkins Medicine Institutional Review Board(JHMIRB). Patients were recruited from our Kennedy Krieger Institute (KKI)medical clinics, physician referrals,and parent organizations. Parents were sent letters of invitation.|
|Pre-assignment Details||Pharmacokinetics in enrolled subjects required her to be a fast metabolizer of Dextromethorphan (DM).|
The trial was terminated due to the FDA requiring a placebo controlled trial instead of the ongoing open label trial. As recruitment was delayed,the total number of participants was also less than anticipated.