Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001
Sponsor
Seaside Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00823368
Collaborator
(none)
11
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Study Start Date
:
Jan 1, 2009
Actual Primary Completion Date
:
Mar 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Arbaclofen followed by Placebo
|
Drug: STX209
|
| Placebo followed by Arbaclofen
|
Drug: STX209
|
Outcome Measures
Primary Outcome Measures
- change in plasma proteins with treatment [After 4 weeks of treatment]
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Years
to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001
Exclusion Criteria:
- Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southwest Autism Research & Resource Center | Phoenix | Arizona | United States | 85006 |
| 2 | University of California-Los Angeles Neuropsychiatric Institute | Los Angeles | California | United States | 90024 |
| 3 | M.I.N.D. Institute | Sacramento | California | United States | 95817 |
| 4 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 5 | Riley Hospital for Children | Indianapolis | Indiana | United States | 46202 |
| 6 | NYS Institute for Basic Research in Developmental Disabilities | Staten Island | New York | United States | 10314 |
| 7 | University of North Carolina Neurosciences Hospital | Chapel Hill | North Carolina | United States | 27514 |
| 8 | Suburban Research Associates | Media | Pennsylvania | United States | 19063 |
| 9 | Vanderbilt Kennedy Center | Nashville | Tennessee | United States | 37203 |
| 10 | Red Oaks Psychiatry Associates, PA | Houston | Texas | United States | 77090 |
| 11 | Seattle Children's Hospital | Seattle | Washington | United States | 98101 |
Sponsors and Collaborators
- Seaside Therapeutics, Inc.
Investigators
- Principal Investigator: Elizabeth Berry-Kravis, MD, PhD, Rush University Medical Center
- Principal Investigator: Randi Hagerman, MD, M.I.N.D. Institute
- 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: Jonathan Picker, MBChB, PhD, Boston Children's Hospital
- Principal Investigator: Linmarie Sikich, MD, University of North Carolina Neurosciences Hospital
- Principal Investigator: Jeremy Veenstra-VanderWeele, MD, Vanderbilt Kennedy Center
- Principal Investigator: Ted Brown, MD, PhD, NYS Institute for Basic Research in Developmental Disabilities
- Principal Investigator: Lawrence Ginsberg, MD, Red Oaks Psychiatry Associates, PA
- Principal Investigator: Shivkumar Hatti, MD, Suburban Research Associates
- Principal Investigator: Raun Melmed, MD, Southwest Autism Research & Resource Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00823368
Other Study ID Numbers:
- 22001A
First Posted:
Jan 15, 2009
Last Update Posted:
Jul 31, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Seaside Therapeutics, Inc.
Additional relevant MeSH terms: