Biomarker and DNA Collection in Subjects Participating in Protocol 22003
This study is ongoing, but not recruiting participants.
Sponsor:
Seaside Therapeutics, Inc.
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00892580
First received: May 1, 2009
Last updated: December 19, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fragile X Syndrome |
Drug: STX209 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
fragile X syndrome
MECP2 duplication syndrome
PPM-X syndrome
Renpenning syndrome
tetrasomy 18p
Drug Information available for:
Deoxyribonucleic acid
U.S. FDA Resources
Further study details as provided by Seaside Therapeutics, Inc.:
Primary Outcome Measures:
- Biomarker [ Time Frame: june 2013 ] [ Designated as safety issue: No ]evaluation of DNA for ASD to elucidate a potential biomaker
Biospecimen Retention: Samples With DNA
DNA from blood, plasma
| Enrollment: | 32 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: STX209
collection of serum for DNA to elucidate a potential biomarker for patients with ASD
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Autism Spectrum Disorder subjects
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892580
Locations
| United States, Arizona | |
| Southwest Autism Research & Resource Center | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| University of California-Los Angeles Neuropsychiatric Institute | |
| Los Angeles, California, United States, 90024 | |
| United States, Connecticut | |
| Yale Child Study Center | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Indiana | |
| Riley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, North Carolina | |
| University of North Carolina Neurosciences Hospital | |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Tennessee | |
| Vanderbilt Kennedy Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Red Oaks Psychiatry Associates, PA | |
| Houston, Texas, United States, 77090 | |
| United States, Washington | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98101 | |
Sponsors and Collaborators
Seaside Therapeutics, Inc.
Investigators
| Principal Investigator: | Craig Erikson, MD | Riley Hospital for Children |
| Principal Investigator: | Bryan King, MD, PhD | Seattle Children's Hospital |
| Principal Investigator: | James McCracken, MD | University of California, Los Angeles |
| Principal Investigator: | Lawrence Scahill, PhD | Yale University |
| Principal Investigator: | Linmarie Sikich, MD | University of North Carolina Neurosciences Hospital |
| Principal Investigator: | Jeremy Veenstra-VanderWeele, MD | Vanderbilt Kennedy Center |
| Principal Investigator: | Lawrence Ginsberg, MD | Red Oaks Psychiatry Associates, PA |
| Principal Investigator: | Raun Melmed, MD | Southwest Autism Research & Resource Center |
More Information
No publications provided
| Responsible Party: | Seaside Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00892580 History of Changes |
| Other Study ID Numbers: | 22003A |
| Study First Received: | May 1, 2009 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Seaside Therapeutics, Inc.:
|
fragile X syndrome biomarkers |
Additional relevant MeSH terms:
|
Fragile X Syndrome Child Development Disorders, Pervasive Mental Retardation, X-Linked Mental Retardation Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Sex Chromosome Disorders |
Chromosome Disorders Congenital Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Mental Disorders Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013