| Seaside Therapeutics is sponsoring a randomized, double-blind, placebo-controlled Phase 3 study to evaluate the effects of STX209 (arbaclofen) on social impairment in people ages 5 to 25 with fragile X syndrome.
These studies will enroll more than 120 subjects. Patients will be randomized to receive STX209 or placebo and then treated over an eight-week period. Subjects who complete the entire study may be eligible to enroll in a subsequent open-label study. The study is designed to measure the efficacy, safety and tolerability of STX209. The primary efficacy endpoint will evaluate social withdrawal. Details of the study can be obtained at clinicaltrials.gov and at www.seasidetherapeutics.com or by calling 1-877-713-9009, ext. 8.
Trial Centers:
Phoenix, AZ: Southwest Autism Research & Resource Center
Dr. Raun Melmed, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Sajitha Puthalath at 602-218-8195 or SPuthalath@autismcenter.org
Long Beach, CA: Miller Children’s Hospital
Dr. Gary Feldman, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Nan O’Donnell at 562-933-5607 or NODonnell@memorialcare.org
Sacramento, CA: MIND Institute, UC Davis
Dr. Randi Hagerman, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Lindsey Partington at 916-703-0471 or Lindsey.Partington@ucdmc.ucdavis.edu
Denver, CO: Children’s Hospital Colorado
Dr. Nicole Tartaglia, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Susan Howell at 720-777-8361 or Susan.howell@childrenscolorado.org
Miami, FL: University of Miami
Dr. Deborah Barbouth, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Elsa Salazar at 305-243-6562 or ESalazar2@med.miami.edu
Orange City, FL: Lake Mary Pediatrics
Dr. Miles Landis, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Heidi Andersen at 386-960-8282 or lmpresearch2@gmail.com
Decatur, GA: Emory University
Dr. Jeannie Visootsak, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Heather Clark at 404-778-8484 or hmclark@emory.edu
Chicago, IL: Rush University
Dr. Elizabeth Berry-Kravis, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Crystal Hervey at 312-942-7250 or Crystal_Hervey@rush.edu
Indianapolis, IN: University of Indiana
Dr. Craig Erickson, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Vanessa Patrick at 317-948-4888 or vpatrick@iupui.edu
Kansas City, KS: Kansas University
Dr. Jessica Hellings, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Anne Nugent at 913-588-5751 or anugent@kumc.edu
Worcester, MA: University of Massachusetts
Dr. Jean Frazier, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Michael Hill at 508-856-2041 or michael.hill@umassmed.edu
Baltimore, MD: Kennedy Krieger Institute
Dr. Walter Kaufmann, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Diane Lanham at 443-923-7613 or lanham@kennedykrieger.org
Columbia, MO: University of Missouri
Dr. David Beversdorf, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Holly Rice at 573-884-3006 or riceh@missouri.edu
Durham, NC: Duke University
Dr. Ave Lachiewicz, Principal Investigator
Recruiting children and adults, ages 5-25,with Fragile X Syndrome.
Contact: Wan Lan Liang at 919-668-0972 or Wan.liang@duke.edu
Akron, OH: Akron Children’s Hospital
Dr. Carol Delahunty, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Jen Michel at 330-543-4738 or jmichel@chmca.org
Media, PA: Suburban Research Associates
Dr. Shivkumar Hatti, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Maureen O’Donnell at 610-891-9024 x 103 or modonnell@suburbanresearch.com
New York, NY: Mount Sinai School of Medicine, Seaver Autism Center
Dr. Alexander Kolevzon, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Lily Schwartz at 212-241-3692 or lily.schwartz@exchange.mssm.edu
Staten Island, NY: NYS Institute of Basic Research
Dr. Ted Brown, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Angelo Porto at 718-494-8028 or porto_a@medscape.com
Oklahoma City, OK: OU Physician's Child Study Center
Dr. Thomas Lock, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Lora Tusing at 405 271-4401 or Lora-Tusing@ouhsc.edu
Nashville, TN: Vanderbilt University
Dr. Jeremy Veenstra-VanderWeele, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Jessica Smith at 615-936-3288or Jessica.smith@Vanderbilt.Edu
Houston, TX: Red Oak Psychiatry
Dr. Lawrence Ginsberg, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Elissa Molloy at 281-893-7559 x 267 or Elissa.molloy@redoakpsychiatry.com
San Antonio, TX: Road Runner Research
Dr. Jerry Tomasovic, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Kristin McGinley at 210-949-0505 or kmcginley@rrresearchsa.com
Seattle, WA: Seattle Children’s Research Institute
Dr. Bryan King, Principal Investigator
Recruiting children and adults, ages 5-25 with Fragile X Syndrome.
Contact: Denise Ward at 206-884-1168 or denise.ward@SeattleChildrens.org
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