Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen by Lawrence Ginsberg, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Seaside Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Elizabeth Berry-Kravis, MD, PhD

Principal Investigator

Rush University Medical Center

Jeremy Veenstra-VanderWeele, MD

Principal Investigator

Vanderbilt Kennedy Center

Ted Brown, MD, PhD

Principal Investigator

NYS Institute for Basic Research in Developmental Disabilities

Jonathan Picker, MBChB, PhD

Principal Investigator

Boston Children's Hospital

Randi Hagerman, MD

Principal Investigator

M.I.N.D. Institute

Bryan King, MD, PhD

Principal Investigator

Seattle Children's Hospital

Linmarie Sikich, MD

Principal Investigator

University of North Carolina Neurosciences Hospital

Craig Erikson, MD

Principal Investigator

Riley Hospital for Children

Raun Melmed, MD

Principal Investigator

Southwest Autism Research & Resource Center

James McCracken, MD

Principal Investigator

University of California, Los Angeles

Shivkumar Hatti, MD

Principal Investigator

Suburban Research Associates

Lawrence Ginsberg, MD

Principal Investigator

Red Oaks Psychiatry Associates, PA

Eligibility Criteria

Inclusion Criteria

Subjects that meet the inclusion

Treatment Details

Interventions

• STX209 (Other)

Participant Groups

Group I: Placebo followed by Arbaclofen Experimental Treatment 1 Intervention

Group II: Arbaclofen followed by Placebo Experimental Treatment 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Southwest Autism Research & Resource Center Phoenix, AZ

Rush University Medical Center Chicago, IL

Seattle Children's Hospital Seattle, WA

M.I.N.D. Institute Sacramento, CA

More Trial Locations

Who Is Running the Clinical Trial?

Seaside Therapeutics, Inc.

Lead Sponsor

Trials

14

Patients Recruited

1,200+