ICTRP Search Portal

Main

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:	NCT00892580
Date of registration:	01/05/2009
Prospective Registration:	Yes
Primary sponsor:	Seaside Therapeutics, Inc.
Public title:	Biomarker and DNA Collection in Subjects Participating in Protocol 22003
Scientific title:	Biomarker Testing and DNA Collection in Subjects Participating in an Open-Label, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Autism Spectrum Disorders
Date of first enrolment:	May 2009
Target sample size:	32
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00892580
Study type:	Observational
Study design:	Observational Model: Cohort, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
United States

Contacts

Name:	Craig Erikson, MD
Address:
Telephone:
Email:
Affiliation:	Riley Hospital for Children

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

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

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

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

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

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

Name:	Lawrence Scahill, PhD
Address:
Telephone:
Email:
Affiliation:	Yale University

Key inclusion & exclusion criteria

Inclusion Criteria:

- The Autism Spectrum Disorder subjects that meet the inclusion and exclusion criteria
and consent to participate in protocol 22003

Exclusion Criteria:

- The Autism Spectrum Disorder subjects that meet the inclusion and exclusion criteria
and consent to participate in protocol 22003

Age minimum: 6 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fragile X Syndrome

Intervention(s)

Drug: STX209

Primary Outcome(s)

Biomarker [Time Frame: june 2013]

Secondary Outcome(s)

Secondary ID(s)

22003A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.