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Completed Phase 2 Interventional Results available

Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome

ClinicalTrials.gov ID: NCT00788073

Public ClinicalTrials.gov record NCT00788073. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 6:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The study objective is to explore the efficacy, safety and tolerability of STX209 for treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve irritability and other typical problem behaviors associated with fragile X syndrome. We also hypothesize that STX209 will be safe and well tolerated.

Study identification

NCT ID
NCT00788073
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Enrollment
63 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years to 40 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2008 (Type not available)
Primary completion
Mar 2010 (Actual)
Completion
May 2010 (Actual)
Last update posted
May 6, 2013

2008 – 2010

United States locations

U.S. sites
12
U.S. states
11
U.S. cities
12
Facility City State ZIP Site status
Southwest Autism Research & Resource Center Phoenix Arizona 85006 —
University of California-Los Angeles Neuropsychiatric Institute Los Angeles California 90024 —
M.I.N.D. Institute Sacramento California 95817 —
Rush University Medical Center Chicago Illinois 60612 —
Riley Hospital for Children Indianapolis Indiana 46202 —
Children's Hospital Boston Boston Massachusetts 02115 —
NYS Institute for Basic Research in Developmental Disabilities Staten Island New York 10314 —
University of North Carolina Neurosciences Hospital Chapel Hill North Carolina 27514 —
Suburban Research Associates Media Pennsylvania 19063 —
Vanderbilt Kennedy Center Nashville Tennessee 37203 —
Red Oaks Psychiatry Associates, P.A. Houston Texas 77090 —
Seattle Children's Hospital Seattle Washington 98101 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00788073, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 6, 2013 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00788073 live on ClinicalTrials.gov.

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