Clinical Trials seeking Participants

This map shows trial centers and below it are contact details (international and US). Clinicaltrials.gov has all Fragile X trials.
     > Novartis mGluR5 Antagonist AFQ056 trial
     > Roche mGluR5 Antagonist RO4917523 trial
     > Seaside STX209 trial has completed enrollment

Blue markers indicate Novartis trial; Yellow markers indicate Roche trial; Green markers mean both trials

 

Novartis mGluR5 Antagonist AFQ056
Last Updated: 5/6/2013
 Centers around the world are enrolling males with full mutation Fragile X aged 12-17 in a Phase IIb trial. This double-blind, placebo-controlled study sponsored by Novartis is designed to assess whether AFQ056 is safe and effective in treating Fragile X Syndrome. AFQ056 decreases mGluR5 activity in the brain. The trial involves 9 visits over 20 weeks; travel costs covered.

Those who complete this trial can take the drug free of charge until the drug is on the market. A preliminary study for ages 3-4 has just started enrolling at Rush in Chicago. 		Roche mGluR5 Antagonist RO4917523
Last Updated: 5/2/2013
 The randomized, double-blind, placebo-controlled clinical study sponsored by Roche is testing an mGluR5 antagonist, which decreases mGluR5 activity in the brain and may improve learning. This trial will assess safety and tolerability of this medicine, as well as its effects on learning, mood and behavior.

All these centers are recruiting males and females ages 14-50 with Fragile X and most are also recruiting children ages 5-13. Please scroll down for international sites. More info at clinicaltrials.gov for ages 14-50 and for ages 5-13.
State Sites Recruiting for Novartis Clinical Trial Sites Recruiting for Roche Clinical Trial
Arizona Phoenix, AZ
Southwest Autism Research & Resource Center
Dr. Raun Melmed, Principal Investigator
Contact Chris Smith at 602-218-8196 or csmith@autismcenter.org  or Sajitha Puthalath at (602) 218-8195 or SPuthalath@autismcenter.org  flyer		 Phoenix, AZ
Southwest Autism Research & Resource Center
Contact: Amanda Akdere at 480-603-3285 or AAkdere@autismcenter.org
Roche trials for ages 14-50
California
 Davis, CA
MIND Institute, UC Davis
Dr. Randi Hagerman, Principal Investigator
Contact: Emma Hare at 916-703-0472 or emma.hare@ucdmc.ucdavis.edu or Norman Brule at norman.blule@ucdmc.ucdavis.edu 		Davis, CA
MIND Institute, UC Davis
Dr. Randi Hagerman, Principal Investigator
Contact: Alyssa Hamlin at (916) 703-0281 or alyssa.hamlin
Roche trials for ages 14-50
Long Beach, CA
Stramski Children’s Development Center
Dr. Gary Feldman, Principal Investigator
Contact: Nan O’Donnell, RN, MS at (562) 933-5607 or nodonnell@memorialcare.org
Roche trials for ages 14-50 and ages 5-13
Colorado
Aurora, CO
Children's Hospital Colorado
Dr. Ann Reynolds, Principal Investigator
Contact: Stephanie Huston at 720-777-8486 or stephanie.huston@childrenscolorado.org
Roche trials for ages 14-50
District of Columbia
Washington, DC
Childrens National Medical Center
Dr. Sinan Turnacioglu, Principal Investigator
Contact: Jurran Wilson at 202.476.2196 or juwilson@childrensnational.org
Roche trials for ages 14-50
Georgia
 Atlanta, GA
Emory University School of Medicine
Dr. Jeannie Visootsak, Principal Investigator
Contact Heather Clark at 404-778-8484 or hmclark@emory.edu or Krista Charen at (404) 778-8479 or kharkre@emory.edu 		Atlanta, GA
Emory University School of Medicine
Dr. Jeannie Visootsak, Principal Investigator
Contact: Heather Clark at (404)778-8484 heather.clark@emoryhealthcare.org
Roche trials for ages 14-50 and ages 5-13
Indiana Indiannapolis, IN
Univ. of Indiana
Dr. Kimberly Stigler, Principal Investigator
Contact: Kristen Ponsler-Sipes at 317-948-4880 or kmponsle@iupui.edu  or Lauren Mathieu-Frasier at lmathieu@iupui.edu
Illinois
 Chicago, IL
Rush Univ. Medical Center
Dr. Elizabeth Berry-Kravis, Principal Investigator
Contact Crystal Hervey at 312-942-7250 or Crystal_Hervey@rush.edu 		Chicago, IL
Rush University Medical Center
Dr. Elizabeth Berry-Kravis, Principal Investigator
Contact: Crystal Hervey at (312)942-7250 or crystal_hervey@rush.edu
Roche trials for ages 14-50 and ages 5-13
Iowa
Iowa City, IA
University of Iowa Healthcare
Dr. Dianne McBrien, Principal Investigator
Contact: Ann Rhomberg at 319-356-0578 or ann-rhomberg@uiowa.edu
Roche trials for ages 14-50
Kentucky
Louisville, KY
Univ. of Louisville, Kosair Charities Pediatric Clin. Research
Dr. Lisa Craft, Principal Investigator
Contact: Janice Sullivan, MD at 502-629-5820 sully@louisville.edu
Roche trials for ages 14-50 and ages 5-13
Maryland
Baltimore, MD
Kennedy Krieger Institute
Contact: Victor Talisa at (443)923-7721 or talisa@kennedykrieger.org
Roche trials for ages 14-50
Massachusetts Boston, MA
Children's Hospital
Dr. Lisa Albers Prock, Principal Investigator
Contact Lucy Abernethy at 857-218-4938 or Lucy.Abernethy@childrens.harvard.edu 		Worcester, MA
U Mass Medical School
Dr. Jean Frazier, Principal Investigator
Contact: Kara Manchester at 508 856 2041 or kara.manchester@umassmed.edu
Roche trials for ages 14-50 and ages 5-13
Nebraska
 Omaha, NE
Univ. of Nebraska Psychopharm. Research Consortium
Dr. Daughton, Principal Investigator
Contact: Brigette Vaughn at 402-552-6239 or bvaughan@unmc.edu or Deb Heimes at deb.heimes@unmc.edu
New York
 Staten Island, NY
NYS Institute for Basic Research
Dr. W. Ted Brown, Principal Investigator
Contact: Dr. Maripaz Gonzalez at 718-494-8028 or Maripaz.Gonzalez@opwdd.ny.gov 		New York, NY
Seaver Autism Center at the Icahn School of Medicine at Mt. Sinai
Contact: Lauren Bush at (212) 241-2826 or Lauren.a.bush@mssm.edu
Roche trials for ages 14-50 and ages 5-13
North Carolina
Durham, NC
Duke University Medical Center
Contact: Wan Liang at (919) 668-0972 wan.liang@duke.edu
Roche trials for ages 14-50
Ohio
Cincinnati, OH
 Cincinnati Childrens Hospital Medical Center
Dr. Craig Erickson, Principal Investigator
Contact: Stephanie Funke at 513-803-1897 or stephanie.funke@cchmc.org
Roche trials for ages 14-50
Pennsylvania
 Media, PA
Suburban Research Associates with Elwyn Fragile X Center
Dr. Shivkumar Hatti, Principal Investigator
Contact: Stephanie Damia at 610-891-9024 or sdamia@suburbanresearch.com 		Media, PA
Suburban Research Associates with Elwyn Fragile X Center
Contact Maureen O’Donnell at 610-891-9024 x103 or modonnell@suburbanresearch.com or Heather Makatche at 610-891-7200
Roche trials for ages 14-50 and ages 5-13
South Carolina
 Greenwood, SC
Greenwood Genetics Center
Dr. Steven Skinner, Principal Investigator
Contact: Fran Annese at 864-941-8100 or  fran@ggc.org
Tennessee
 Nashville, TN:
Vanderbilt University Medical Center
Dr. Jeremy VeenstraVanderWeele, Principal Investigator
Contact: Sarah Marler at (615) 936-3288 or sarah.marler@vanderbilt.edu 		Nashville, TN
Vanderbilt Kennedy Center
Contact: Sarah Marler at (615) 936-3288 or sarah.marler@vanderbilt.edu
Roche trials for ages 14-50 and ages 5-13
Texas
San Antonio, TX
Road Runner Research
Dr. Jerry Tomasovic, Principal Investigator
Contact: Kathryn Johanningmeier RN at 210-949-0505 or kjohanningmeier@rrresearchsa.com
Roche trials for ages 14-50 and ages 5-13
Houston, TX
Texas Children's Hospital - Clinical Care Center
Dr. Diane Treadwell Deering, Principal Investigator
Roche trial for ages 5-13
Washington State
 Bellevue, WA
Northwest Clinical Research Center
Dr. Arifulla Khan, Principal Investigator
Contact: Christine Khan at 425-453-0404 or ckhan@nwcrc.net or Yukiko Duncan yduncan@nwcrc.net 		Seattle, WA
Seattle Children’s Research Institute
Dr. Bryan King, Principal Investigator
Contact: Denise Ward at (206) 884-1168 or denise.ward@seattlechildrens.org
Roche trials for ages 14-50 and ages 5-13


     Outside the US these sites are also recruiting. Please email us if you can help us find site contact details

Country Sites Recruiting for Novartis Clinical Trial Sites Recruiting for Roche Clinical Trial
Australia Parkville, Victoria, 3052    Contact Martin Delatycki, Prof. at +61 39 49 64 355 or martin.delatycki@ghsv.org.au
Westmead, New South Wales, 2145    Contact Natalie Silove at +61 2 9 84 52 829
Argentina
Buenos Aires C1425CDC - CENAGEM (Centro Nacional de Genética Médica) at the Rivadavia Hospital www.anlis.gov.ar/centro-nacional-de-genetica-medica/autoridades Contact Dra. Liliana Alba, Director, at lalba@anlis.gov.ar
Canada Montreal, Quebec, H3T1C5 - Contact: Jacques Michaud, Dr. at +1 514 345 4931 ext 2554 or jacques.michaud@recherche-ste-justine.qc.ca Brampton, Ontario, L6Y 1M5 - Contact Dr. Carlo Paribello at 905-453-9366 or fxrfc@on.aibn.com
Chile
Valparaiso, 2340000
Denmark
 Glostrup, 2600 - Contact: METTE Kaltoft-Soerensen, RN at +45 43 26 01 00 or   MES@Kennedy.dk 

France Bron         Contact: Vincent Des Portes, MD, PhD     +33 (0)4 27 85 53 82     vincent.desportes@chu-lyon.fr 
Paris         Contact: Perrine Charles, MD, PhD     +33 (0)1 42 16 13 46 or charles.perrine@psl.aphp.fr 
Bordeaux, 33076
Dijon, 21079
Marseille, 13385
Montpellier, 34295
Tours, 37044
Germany
 Dresden, 01307       Contact: Veit Roessner, Prof. Dr     +49 (0) 351 458 22 44     veit.roessner@uniklinikum-dresden.de  
Mainz, D-55101      Contact: Michael Huss, Prof.Dr.     +49 (0)6131 17 3280     Michael.huss@ukmainz.de   
München, 80639      Contact: Adam Alfred, Dr.     +49 (0)89 13 99 8829     adamalfred@t-online.de
Tübingen, 72076     Contact: Gottfried Barth, Dr.         KJP-Studien@med.uni-tuebingen.de
Würzburg, 97070    Contact: Klaus-Ulrich Oehler, Dr.     +49 (0)931 32 92 868     info@med-studienzentrum.de
Israel
 Ramat Gan, 52621     Contact: Lidia Gabis, Dr.     +972 3 530 2236     lidiagabis@gmail.com
Italy
 Genova, GE, 16147     Contact: Edvige Veneselli, Prof     +39 010 5636 432     edvigeveneselli@ospedale-gaslini.ge.it    
Roma, RM, 00168      Contact: E.M. Mercuri, Prof.     +39 06 30 15 5340
Padova, 35128    Contact: Alessandra Murgia, MD, PhD     +39 049 821 1430     allessandra.murgia@unipd.it
Spain Sant Cugat, Barcelona, 08190
Sabadell, Cataluña, 08208
El Palmar. Murcia, 30120
Madrid, 28040
Madrid,  28046
San Cugat Del Valles, 08195
San Sebastian, 20009
Torremolinos, 29620
Sweden
 Stockholm, 171 76     Contact: Malena Kjéllen, RN     +46 (0)8 5177 74 50     malena.kjellen@karolinska.se
Switzerland
 Lausanne          
Zurich, 8091    Contact: Anita Rauch, Prof. Dr.     +41 (0)44 655 7053     anita.rauch@medgen.uzh.ch
United Kingdom Edinburgh, EH10 5HF     Contact: Andrew Stanfield, Dr.     +44 (0) 131 537 6265     andrew.stanfield@ed.ac.uk 
Belfast, BT12 6AB Contact Dr Francis Anthony O'Neill at 028 906 32580,or email tony.oneill@qub.ac.uk
Dundee, DD1 9SY  Contact Dr. Jonathan N Berg at j.n.berg@dundee.ac.uk or  01382 383481
Edinburgh, EH10 5HF  Contact Dr. Andrew McKechanie, Clinical Research Fellow at andrew.mckechanie@ed.ac.uk or 0131  537  6685
Glasgow, GS 8SJ  Contact Margaretha van Mourik at Margaretha.VanMourik@yorkhill.scot.nhs.uk or 0141  354  9261
London, W1W 7EJ Dr Andre Strydom at 0207  6799  308
Manchester, M13 9WL Professor Jill Clayton-Smith at 0161 701 4914,  email Genetics.Research@cmft.nhs.uk

 

 

Seaside GABAb agonist STX209 a.k.a. "Arbaclofen"
Date Posted: 1/7/2012, Last Updated: 2/27/2012
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 50 with fragile X syndrome. These studies have completed enrollment and results are expected in the spring of 2013.

Today Seaside has informed us that the open-label study of this drug may be ended in several months due to unanticipated resource issues. Learn more at clinicaltrials.gov and at www.seasidetherapeutics.com or by calling 1-877-713-9009, ext. 8.

 

 

General Information About Participating in Clinical Trials
Thank you for being interested in participation in a clinical trial for Fragile X! FRAXA has been working since 1994 to discover treatments for Fragile X and get them to market. We are getting so close! This is a challenging new phase for all of us; this part involves our children. As exciting as it is, we know many of you have questions about what it really means to be in a clinical trial.

There are now many clinics around the world where children and adults with Fragile X can take part in a study where they will take a trial medication. Each of these studies is supervised by a doctor that specializes in Fragile X. These medicine trials are free. You do not have to tell your insurance company, and you can leave a trial any time you want. Travel costs are usually covered.

It is important that these studies be completed because only after they are completed can the FDA approve new treatments. If the studies are successful and the FDA approves new drugs, others with Fragile X can also have access to these medicines. Look here for Freqently Asked Questions about Trials

We are looking forward to this voyage with all of you on board – this is the great result of all of your support throughout the years and we are hopeful that these trials will be successful for the sake of all affected by Fragile X.

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