Module 11

Module 11 – Clinical Trials and Studies

Moico Module 9 Alt

Details of clinical trials and studies the participant is involved in or has been involved in including Natural History studies and Angelman clinics.

11.1 Clinics and Research Studies (ANGOtherStudy)
NoCodeQuestionResponse
11.0.1ANGOtherStudyYNUHas your child/ adult ever been involved in any research studies or clinical trials?1 – Yes;
2 – No;
3 – Unknown
11.0.2ANGClinicYNUHas your child/ adult ever attended an Angelman Syndrome clinic?1 – Yes;
2 – No;
3 – Unknown

 

11.2 Study Participation (ANGAdditionalInformation)
NoCodeQuestionResponse
11.2.1ANGOtherStudyWhat2Name of study/ trial

1 – Natural History Trial 2011-2014

2 – Natural History Study 2018 onward

3 – Metfolin Trial (Dietary Supplements for the Treatment of Angelman Syndrome)

4 – Levodopa Trial

5 – Minocycline Trial (Minocycline in the Treatment of Angelman Syndrome) – University of South Florida, Tampa, FL (Ed Weeber);

6 – Minocycline Trial (Study to Evaluate the Efficacy and Safety of Minocycline in Angelman Syndrome A-MANECE) – Puerta de Hierro University Hospital, Spain (Belen Ruiz-Antorán);

7 – Ovid Trial;

8 – MRI trial – Baylor College of Medicine, Houston, TX (Sarika Peters);

9 – Ovid STARS Trial (A Study in Adults and Adolescents With Angelman Syndrome);

10 – MRI trial at UNC, Chapel Hill, NC (Heather Hazlett);

11 – Gait trial – University of South Florida, Tampa, FL (Joe Grieco);

12 – Lena device trial – University of South Florida, Tampa, FL (Ruth Bahr);

13 – Sleep trial (Kansas);

14 – Study on the Brain Network of Angelman Syndrome, Fudan University, China (Dr Yi Wang);

15 – Disruptive Nutrition FANS/ketone trial;

16 – GeneTX KIK-AS trial;

17 – Roche & Genetech FREESIAS Endpoint Study;

18 – Roche Tangelo Clinical trial;

19 – Other

11.2.2ANGOtherStudyOther2Name of study/ trialText
11.2.3ANGOtherStudyPartAre you still participating in other study/ trial?1 – Yes; 2 – No
11.2.4MinocyclineTrialAAre you still participating in the Minocycline Trial (Minocycline in the Treatment of Angelman Syndrome)?1 – Yes; 2 – No
11.2.5MinocyclineTrialBAre you still participating in the Minocycline Trial (Study to Evaluate the Efficacy and Safety of Minocycline in Angelman Syndrome A-MANECE)?1 – Yes; 2 – No
11.2.6MRITrialAAre you still participating in the MRI trial at Baylor College of Medicine?1 – Yes; 2 – No
11.2.7MRITrialBAre you still participating in the MRI trial at UNC?1 – Yes; 2 – No
11.2.8GaitTrialAre you still participating in the Gait trial at the University of South Florida?1 – Yes; 2 – No
11.2.9LenaTrialAre you still participating in the Lena device trial at the University of South Florida?1 – Yes; 2 – No
11.2.10SleepTrialAre you still participating in the Sleep trial at Kansas?1 – Yes; 2 – No
11.2.11DisNutYNAre you still participating in the Disruptive Nutrition FANS/ketone trial?1 – Yes; 2 – No
11.2.12GeneTXYNAre you still participating in the GeneTX KIK-AS trial?1 – Yes; 2 – No
11.2.13FREESIASYNAre you still participating in the Roche & Genetech FREESIAS Endpoint Study?1 – Yes; 2 – No
11.2.14TangeloYNAre you still participating in the Roche Tangelo Clinical trial?1 – Yes; 2 – No
11.2.15BrainTrialAre you still participating in the Study on the Brain Network of Angelman Syndrome, Fudan University, China (Dr Yi Wang)1 – Yes; 2 – No
11.2.16NaturalHistSiteWhich 2011-2014 Natural History Study site?

1 – Baylor-Texas Children’s, Houston, TX.  (Carlos Bacino);

2 – Rady Children’s Hospital, San Diego, CA (Lynne Bird);

3 – Children’s Hospital, Boston, MA (Virginia Kimonis then Wen-Hann Tan);

4 – Greenwood Genetics Center, Greenwood, SC (Steve Skinner);

5 – UCSF, San Francisco, CA (Anne Slavotinek);

6 – Children’s Hospital, Cincinnati, OH (Logan Wink);

7 – Vanderbilt Children’s Hosptial, Nashville, TN (Greg Barnes, then Cary Fu);

11.2.17NaturalHistSiteNewWhich 2018-current Natural History Study site?1 – Rady Children’s Hospital, San Diego, CA; 2 – Children’s Hospital, Boston; 3 – Other
11.2.18NaturalHistSiteNewOthIf other, please stateText
11.2.19NaturalHistYNAre you still participating in the Natural History Study?1 – Yes; 2 – No
11.2.20FolicBetaineSiteWhich Folic Acid/Betaine Trial site?

1 –  Baylor-Texas Children’s, Houston, TX.  (Art Beaudet then Carlos Bacino);

2 – Rady Children’s Hospital, San Diego, CA (Lynne Bird);

3 – Children’s Hospital, Boston, MA (Wen-Hann Tan);

4 – Greenwood Genetics Center, Greenwood, SC (Steve Skinner);

11.2.21FolicBetaineYNre you still participating in the Folic Acid/Betaine Trial?1 – Yes; 2 – No
11.2.22MetafolinSiteWhich Metafolin Trial (Dietary Supplements for the Treatment of Angelman Syndrome) site?

1 – Baylor-Texas Children’s, Houston, TX.  (Carlos Bacino);

2 – Rady Children’s Hospital, San Diego, CA (Lynne Bird);

3 – Children’s Hospital, Boston, MA (Wen-Hann Tan);

4 – Greenwood Genetics Center, Greenwood, SC (Steve Skinner);

11.2.23MetafolinYNAre you still participating in the Metafolin Trial?1 – Yes; 2 – No
11.2.24LevodopaSiteWhich Levodopa Trial site?

1 – Baylor-Texas Children’s, Houston, TX.  (Carlos Bacino);

2 – Rady Children’s Hospital, San Diego, CA (Lynne Bird);

3 – Children’s Hospital, Boston, MA (Wen-Hann Tan);

4 – Greenwood Genetics Center, Greenwood, SC (Steve Skinner);

5 – UCSF, San Francisco, CA (Anne Slavotinek);

6 – Children’s Hospital, Cincinnati, OH (Logan Wink);

7 – Vanderbilt Children’s Hospital, Nashville, TN (Greg Barnes, then Cary Fu);

11.2.25LevodopaYNAre you still participating in the Levodopa Trial?1 – Yes; 2 – No
11.2.26OvidTrialSiteWhich Ovid Trial site?

1 – Baylor-Texas Children’s, Houston, TX.  (Carlos Bacino);

2 – Rady Children’s Hospital, San Diego, CA (Lynne Bird);

3 – Children’s Hospital, Boston, MA (Wen-Hann Tan);

4 – Massachusetts General Hospital, Boston, MA (Ron Thibert);

5 – Greenwood Genetics Center, Greenwood, SC (Steve Skinner);

6 – Children’s Hospital, Cincinnati, OH (Logan Wink);

7 – Vanderbilt Children’s Hospital, Nashville, TN (Kevin Haas);

11.2.27OvidTrialYNAre you still participating in the Ovid Trial?1 – Yes; 2 – No
11.2.28OvidSTARSsite

Which Ovid STARS Trial (A Study in Adults and Adolescents With Angelman Syndrome) Site?

Arizona

California

Florida

Georgia

1 –  Arizona

2 –  California

3 –  Florida

4 –  Georgia

5 –  Illinois

6 –  Massachusetts

7 –  Ohio

8 –  Pennsylvania

9 –  South Carolina

10 – Tennessee

11 –  Israel

11.2.29OvidSTARSTrialYNAre you still participating in the Ovid STARS Trial?1 – Yes; 2 – No

 

11.3 Clinic attendance (ANGClinic)
No Code Question Response
11.3.1 ClinicSite Region where clinic(s) located 1 – United States of America;
2 – Other North America;
3 – South America;
4 – Europe;
5 – Asia;
6 – Africa;
7 – Oceania
11.3.2 ClinicSiteUSA Which clinic(s) in the United States of America? 1 – Seattle Children’s Hospital (Seattle, Washington US);
2 – UCSF Benioff Children’s Hospital (San Francisco, California US);
3 – UCLA CART Center for Autism Research and Treatment (Los Angeles, California US);
4 – Rady Children’s Hospital San Diego (San Diego, California US) ;
5 – Intermountain Primary Children’s Medical Center (Salt Lake City, Utah US);
6 – Children’s Hospital Colorado (Aurora, Colorado US);
7 – Texas Children’s Hospital (Houston, Texas US);
8 – Mayo Clinic (Rochester, Minnesota US) ;
9 – Minnesota Epilepsy Group (St. Paul, Minnesota US);
10 – Rush University Medical Center (Chicago, Illinois US);
11 – Lurie Children’s Hospital Chicago (Chicago, Illinois US);
12 – Monroe Carell Jr. Children’s Hospital (Nashville, Tennessee US);
13 – Geisinger Autism & Developmental Medicine Institute (Lewisburg, Pennsylvania US);
14 – NYU Langone Medical Center (New York, New York US);
15 – Weill Cornell Medical College of New York (New York, New York US);
16 – Massachusetts General Hospital (Boston, Massachusetts US);
17 – UNC Carolina Institute for Developmental Disabilities (Carrboro, North Carolina US);
18 – Miami Children’s Hospital (Miami, Florida US);
19 – Other
11.3.3 WhatOtherClinicUSA Name and location Text
11.3.4 OtherClinicUSA Are you still attending this clinic? 1 – Yes; 2 – No
11.3.5 SeattleClinic Are you still attending the Seattle Children’s Hospital? 1 – Yes; 2 – No
11.3.6 BenioffClinic Are you still attending the UCSF Benioff Children’s Hospital? 1 – Yes; 2 – No
11.3.7 CARTClinic Are you still attending the UCLA CART Center for Autism Research and Treatment? 1 – Yes; 2 – No
11.3.8 RadyClinic Are you still attending the Rady Children’s Hospital San Diego? 1 – Yes; 2 – No
11.3.9 IntermountainClinic Are you still attending the Intermountain Primary Children’s Medical Center? 1 – Yes; 2 – No
11.3.10 ColoradoClinic Are you still attending the Children’s Hospital Colorado? 1 – Yes; 2 – No
11.3.11 TexasClinic Are you still attending the Texas Children’s Hospital? 1 – Yes; 2 – No
11.3.12 MayoClinic Are you still attending the Mayo Clinic? 1 – Yes; 2 – No
11.3.13 MinnesotaClinic Are you still attending the Minnesota Epilepsy Group? 1 – Yes; 2 – No
11.3.14 RushClinic Are you still attending the Rush University Medical Center? 1 – Yes; 2 – No
11.3.15 LurieClinic Are you still attending the Lurie Children’s Hospital Chicago? 1 – Yes; 2 – No
11.3.16 MonroeClinic Are you still attending the Monroe Carell Jr Children’s Hospital? 1 – Yes; 2 – No
11.3.17 GeisingerClinic Are you still attending the Geisinger Autism & Developmental Medicine Institute? 1 – Yes; 2 – No
11.3.18 LangoneClinic Are you still attending the NYU Langone Medical Center? 1 – Yes; 2 – No
11.3.19 CornellClinic Are you still attending the Weill Cornell Medical College of New York? 1 – Yes; 2 – No
11.3.20 MassachusettsClinic Are you still attending the Massachusetts General Hospital? 1 – Yes; 2 – No
11.3.21 CarolinaClinic Are you still attending the UNC Carolina Institute for Developmental Disabilities? 1 – Yes; 2 – No
11.3.22 MiamiClinic Are you still attending the Miami Children’s Hospital? 1 – Yes; 2 – No
11.3.23 ClinicSiteNorthAmerica Which clinic(s) in other North American countries? 1 – Children’s Hospital of Eastern Ontario (Ottowa, Canada);
2 – BC Children’s Hospital; 3 Other
11.3.24 WhatOtherClinicNorthAmerica Name and location Text
11.3.25 OtherClinicNorthAmerica Are you still attending this clinic? 1 – Yes; 2 – No
11.3.26 OntarioClinic Are you still attending the Children’s Hospital of Eastern Ontario (Ottowa, Canada) 1 – Yes; 2 – No
11.3.27 BritishColumbiaClinic Are you still attending the BC Children’s Hospital 1 – Yes; 2 – No
11.3.28 ClinicSiteSouthAmerica Which clinic(s) in South America? 1 – Brazil Angelman Clinic;
2 – Argentina Angelman Syndrome Clinic;
3 – Other
11.3.29 WhatOtherClinicSouthAmerica Name and location the  Text
11.3.30 OtherClinicSouthAmerica Are you still attending this clinic? Text
11.3.31 BrazilClinic Are you still attending the Brazil Angelman Clinic 1 – Yes; 2 – No
11.3.32 ArgentinaClinic Are you still attending the Argentina Angelman Syndrome Clinic 1 – Yes; 2 – No
11.3.33 ClinicSiteEurope Which clinic(s) in Europe? 1 – Erasmus Angelman Syndrome Center, Rotterdam, The Netherlands;
2 – St Mary’s Hospital, Manchester, UK;
3 – Edmond and Lily Safra Children’s Hospital, Sheba Tel Hashomer (Tel Aviv, Israel);
4 – Other
11.3.34 WhatOtherClinicEurope Name and location Text
11.3.35 OtherClinicEurope Are you still attending this clinic? 1 – Yes; 2 – No
11.3.36 ErasmusClinic Are you still attending the Erasmus Angelman Syndrome Center, Rotterdam, The Netherlands 1 – Yes; 2 – No
11.3.37 StMaryClinic Are you still attending the St Mary’s Hospital, Manchester, UK 1 – Yes; 2 – No
11.3.38 ClinicSiteAsia Which clinic(s) in Asia? 1 – Edmond and Lily Safra Children’s Hospital, Sheba Tel Hashomer (Tel Aviv, Israel);
2 – Other
11.3.39 WhatOtherClinicAsia Name and location Name and location
11.3.40 OtherClinicAsia Are you still attending this clinic? Are you still attending this clinic?
11.3.41 ClinicSiteAfrica Which clinic(s) in Africa? 1 – Edmond and Lily Safra Children’s Hospital, Sheba Tel Hashomer (Tel Aviv, Israel) ;
2 – Other
11.3.42 WhatOtherClinicAfrica Name and location Text
11.3.43 OtherClinicAfrica Are you still attending this clinic? 1 – Yes; 2 – No
11.3.44 IsraelClinic Are you still attending the Edmond and Lily Safra Children’s Hospital? 1 – Yes; 2 – No
11.3.45 ClinicSiteOceania Which clinic(s) in Oceania? 1 – Melbourne Royal Children’s Hospital Clinic;
2 – Development Assessment Service, St George Hospital, Kogarah, NSW;
3 – Other
11.3.46 WhatOtherClinicOceania Name and location
11.3.47 OtherClinicOceania Are you still attending this clinic? 1 – Yes; 2 – No
11.3.48 MelbourneClinic Are you still attending the Melbourne Royal Children’s Hospital Clinic? 1 – Yes; 2 – No
11.3.49 KogorahClinic Are you still attending the Development Assessment Service, St George Hospital? 1 – Yes; 2 – No
Providing Insight & Research into Angelman Syndrome
Creating new opportunities, insight & understanding.
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