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Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00823368
Enrollment
Unknown
Registered
2009-01-15
Start date
2009-01-31
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 22001 will be offered participation in 22001A 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

Sponsors

Seaside Therapeutics, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Subjects that meet the inclusion and

Exclusion criteria

and consent to participate in protocol 22001

Design outcomes

Primary

MeasureTime frame
change in plasma proteins with treatmentAfter 4 weeks of treatment

Countries

United States

Outcome results

None listed

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