Dear Fragile X family member,

Seaside Therapeutics is studying the science of the brain and working to deliver treatments that improve the underlying causes of developmental disorders like Fragile X syndrome. Right now, Seaside is testing an investigational medicine called STX209 (arbaclofen) for individuals with Fragile X syndrome with social impairment. Thanks to the dedication and efforts of families, one of the clinical trials is almost complete.

We are reaching out to you because you may be a caregiver to a person with Fragile X syndrome and your family member may be eligible for the next study, the Harbor-C trial.

This trial is 70% completed and your family’s participation in this clinical trial can help drive this study to completion, furthering the advancement of new potential treatments for Fragile X syndrome.

  • HARBOR-C is seeking children with Fragile X syndrome (ages 5 to 11)

Please go to www.harbortrial.com to learn more about this clinical study and consider contacting the most convenient clinical study site to your home to inquire further. For your convenience, we have included the list of clinical study sites on the below.

Social impairment seen in people with Fragile X syndrome can appear in many different ways. If your family member shows any of the following behaviors, or any others that limit their ability to form social connections (compared to typically developing children or adults), he or she may be eligible to participate in the Harbor Trials:

  • Is not able to read social cues
  • Has difficulty with social behavior
  • Is unable to understand social nuances
  • Is difficult to reach or contact
  • Has a negative response to affection
  • Is socially awkward

The Harbor Trials are designed to test the safety and effectiveness of the investigational drug STX209 (arbaclofen) versus placebo (inactive pills) in improving social function in people with Fragile X syndrome. Eligible participants will receive up to 2 months of treatment with the study drug (STX209 or placebo) and can continue on STX209 in a long-term follow up study. Travel cost reimbursement is available.
This study is sponsored by Seaside Therapeutics. 27 sites in the U.S. are currently enrolling. Additional information may be found on www.harbortrial.com or www.clinicaltrials.gov (references # NCT01282268 and NCT01325220).

To learn more about participating in the Harbor-C trial, please contact a clinical study coordinator at the clinical site nearest you.

Clinic Study Sites and Contact Info

Arizona
Southwest Autism Research and Resource Center
Phoenix, AZ
Study Coordinator: Sajitha Puthalath
SPuthalath@autismcenter.org
(602) 218-8195

California
Miller Children’s Hospital
Long Beach, CA
Study Coordinator: Nan O’Donnell
NODonnell@memorialcare.org
(562) 933-5607

Psychiatric Associates of San Diego
San Diego, CA
Study Coordinator: Christine Moloney
cmoloney@psychiatriccenters.com
(619) 692-1003

University of California-Davis, M.I.N.D. Institute
Sacramento, CA
Study Coordinator: Lindsey Partington
Lindsey.Partington@ucdmc.ucdavis.edu
(916) 703-0471

Colorado
University of Colorado Denver, Children’s Hospital
Aurora, CO
Study Coordinator: Susan Howell
Howell.Susan@tchden.org
(720) 777-8361

Florida
University of Miami, Miller School of Medicine, Mailman Center for Child Development
Miami, FL
Study Coordinator: Elsa Salazar
ESalazar2@med.miami.edu
(305) 243-6562

Lake Mary Pediatrics
Orange City, FL
Study Coordinator: Heidi Andersen
lmpresearch2@gmail.com
(386) 960-8282

Georgia
Emory University School of Medicine, Division of Medical Genetics
Decatur, GA
Study Coordinator: Heather Clark
hmclark@emory.edu
(404) 778-8484

Illinois
Rush University Medical Center
Chicago, IL
Study Coordinator: Shaguna Mathur
shaguna_mathur@rush.edu
(312) 563-9533

Kansas
University of Kansas Medical Center
Kansas City, KS
Study Coordinator: Phyllis Young
pyoung@kumc.edu
(913) 588-5741

Maryland
Kennedy Krieger Institute
Baltimore, MD
Study Coordinator: Kennedy Krieger, Victor Talisa
talisa@kennedykrieger.org
(443) 923-7721

Massachusetts
University of Massachusetts
Worcester, MA
Study Coordinator: Kara Manchester
kara.manchester@umassmed.edu
(508) 856-2041

Michigan
Children’s Hospital of Michigan (Coming Soon)
Detroit, MI

Missouri
University of Missouri, Thompson Research Center for Autism & Neurodevelopmental Disorders
Columbia, MO
Study Coordinator: Patsy Weis
weisp@missouri.edu
(573) 882-5595

New York
Mount Sinai School of Medicine
New York, NY
Study Coordinator: Lauren Bush
lauren.a.bush@mssm.edu
(212) 241-3692

NYS Institute of Basic Research in Developmental Disabilities
Staten Island, NY
Study Coordinator: Angelo Porto
porto_a@medscape.com
(718) 494-8028

North Carolina
Duke University Medical Center
Durham, OH
Study Coordinator: Wan Lan Liang
wan.liang@duke.edu
(919) 668–0972

Cincinnati
Cincinnati Children’s Hospital (Coming Soon)
Cincinnati, OH

Oklahoma
University of Oklahoma, Physician’s Child Study Center
Oklahoma City, OK
Study Coordinator: Lora Tusing
Lora-Tusing@ouhsc.edu
(405) 271-4401

Pennsylvania
Suburban Research Associates /Associates / Elwyn Genetics
Media, PA
Study Coordinator: Maureen O’Donnell
modonnell@suburbanresearch.com
(610) 891-9024 ext. 103

South Carolina
Greenwood Genetics Center (Coming Soon)
Greenwood, SC

Tennessee
Vanderbilt University
Nashville, TN
Study Coordinator: Jessica Smith
jessica.smith@vanderbilt.edu
(615) 936-3288

Texas
Children’s Medical Center (Coming Soon)
Dallas, TX

Red Oaks Psychiatry Associates, P.A.
Houston, TX
Study Coordinator: Elissa Molloy
elissa.molloy@redoakpsychiatry.com
(832) 824-4275

Texas Children’s Hospital
Houston, TX
Study Coordinator: Brenda Noggy
bxnoggy@texaschildrens.org
(832) 824-4275

Road Runner Research
San Antonio, TX
Study Coordinator: Katie Johanningmeier
kjohanningmeier@rrresearchsa.com
(210) 949-0505

Washington
Seattle Children’s Hospital
Seattle, WA
Study Coordinator: Denise Ward
denise.ward@SeattleChildrens.org
(206) 884-1168