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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.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00823368
Date of registration:	13/01/2009
Prospective Registration:	No
Primary sponsor:	Seaside Therapeutics, Inc.
Public title:	Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001
Scientific title:	Biomarker Testing and DNA Collection in Subjects Participating in a Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X Syndrome
Date of first enrolment:	January 2009
Target sample size:
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00823368
Study type:	Observational
Study design:	Observational Model: Cohort, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
United States

Contacts

Name:	Craig Erikson, MD
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Affiliation:	Riley Hospital for Children

Name:	Lawrence Ginsberg, MD
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Affiliation:	Red Oaks Psychiatry Associates, PA

Name:	Bryan King, MD, PhD
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Affiliation:	Seattle Children's Hospital

Name:	Shivkumar Hatti, MD
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Affiliation:	Suburban Research Associates

Name:	Jonathan Picker, MBChB, PhD
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Affiliation:	Children's Hospital Boston

Name:	Linmarie Sikich, MD
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Affiliation:	University of North Carolina Neurosciences Hospital

Name:	Ted Brown, MD, PhD
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Affiliation:	NYS Institute for Basic Research in Developmental Disabilities

Name:	Elizabeth Berry-Kravis, MD, PhD
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Affiliation:	Rush University Medical Center

Name:	Randi Hagerman, MD
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Affiliation:	M.I.N.D. Institute

Name:	Raun Melmed, MD
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Affiliation:	Southwest Autism Research & Resource Center

Name:	James McCracken, MD
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Affiliation:	University of California, Los Angeles

Name:	Jeremy Veenstra-VanderWeele, MD
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Affiliation:	Vanderbilt Kennedy Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects that meet the inclusion and exclusion criteria and consent to participate in
protocol 22001

Exclusion Criteria:

- Subjects that meet the inclusion and exclusion criteria and consent to participate in
protocol 22001

Age minimum: 6 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fragile X Syndrome

Intervention(s)

Drug: STX209

Primary Outcome(s)

change in plasma proteins with treatment [Time Frame: After 4 weeks of treatment]

Secondary Outcome(s)

Secondary ID(s)

22001A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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