Fragile X SyndromeNCT00892580
Biomarker and DNA Collection in Subjects Participating in Protocol 22003
An observational study of Fragile X Syndrome, run by Seaside Therapeutics, Inc. at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Fragile X Syndrome
- What is being tested?
- STX209
- How many people
- 32 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2009to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Autism Spectrum Disorder subjects
Who may be able to join
- The Autism Spectrum Disorder subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22003
Who cannot join
- The Autism Spectrum Disorder subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22003
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of North Carolina Neurosciences Hospital
Chapel Hill, North Carolina, 27514
Red Oaks Psychiatry Associates, PA
Houston, Texas, 77090
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, 90024
Vanderbilt Kennedy Center
Nashville, Tennessee, 37203
Yale Child Study Center
New Haven, Connecticut, 06520
Southwest Autism Research & Resource Center
Phoenix, Arizona, 85006
Seattle Children's Hospital
Seattle, Washington, 98101
About this study
Official 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
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.
- Conditions
- Fragile X Syndrome
- Being tested
- STX209
- Keywords
- fragile X syndrome, biomarkers
- Medical subject headings
- Fragile X Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STX209Drug
collection of serum for DNA to elucidate a potential biomarker for patients with ASD
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker
evaluation of DNA for ASD to elucidate a potential biomaker
Measured: june 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fragile X SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seaside Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Erikson, MD, Principal investigator, Riley Hospital for ChildrenBryan King, MD, PhD, Principal investigator, Seattle Children's HospitalJames McCracken, MD, Principal investigator, University of California, Los AngelesLawrence Scahill, PhD, Principal investigator, Yale UniversityLinmarie Sikich, MD, Principal investigator, University of North Carolina Neurosciences HospitalJeremy Veenstra-VanderWeele, MD, Principal investigator, Vanderbilt Kennedy CenterLawrence Ginsberg, MD, Principal investigator, Red Oaks Psychiatry Associates, PARaun Melmed, MD, Principal investigator, Southwest Autism Research & Resource Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892580
- Sponsor's protocol ID
- 22003A
- Status last verified
- Jul 2013
- First submitted
- 1 May 2009
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00892580
- Acronym / sponsor ID
- 22003A
- Conditions
- Fragile X Syndrome
- Keywords
- fragile X syndrome, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seaside Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- First posted
- 4 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Autism Spectrum Disorder subjects
Key inclusion criteria (1 listed)
- The Autism Spectrum Disorder subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22003
Key exclusion criteria (1 listed)
- The Autism Spectrum Disorder subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22003
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STX209collection of serum for DNA to elucidate a potential biomarker for patients with ASD | Drug | – |
Primary outcome
Biomarker
Time frame: june 2013
evaluation of DNA for ASD to elucidate a potential biomaker
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Erikson, MD principal investigator
Riley Hospital for Children
Bryan King, MD, PhD principal investigator
Seattle Children's Hospital
James McCracken, MD principal investigator
University of California, Los Angeles
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fragile X Syndrome, run by Seaside Therapeutics, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker (time frame: june 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2013.