Biomarker and DNA Collection in Subjects Participating in Protocol 22003

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00892580

Enrollment

Registered

2009-05-04

Start date

2009-05-31

Completion date

Unknown

Last updated

2013-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fragile X Syndrome

Keywords

fragile X syndrome, biomarkers

Brief summary

The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22003 will be offered participation in 22003A which will evaluate secreted protein before and after treatment with STX209 and placebo to determine if they correlate with effectiveness of treatment or susceptibility to treatment with STX209. These same subjects will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection. The investigators will study the DNA to determine if STX209 works better in people with specific gene variations, or to find new gene variations that predict how well STX209 works.

Interventions

DRUGSTX209

collection of serum for DNA to elucidate a potential biomarker for patients with ASD

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Healthy volunteers

Inclusion criteria

* The Autism Spectrum Disorder subjects that meet the inclusion and

Exclusion criteria

and consent to participate in protocol 22003

Design outcomes

Primary

Measure	Time frame	Description
Biomarker	june 2013	evaluation of DNA for ASD to elucidate a potential biomaker

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026