A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Fragile X Syndrome

Date Added
June 25th, 2021
PRO Number
Pro00112028
Researcher
Caroline Buchanan

List of Studies

Keywords
Genetics
Summary

The Drug Product ZYN002 is a transdermal CBD gel. CBD is the primary non-euphoric cannabinoid contained in the Cannabis sativa L. plant. The CBD contained within ZYN002 is a pharmaceutically produced Active Pharmaceutical Ingredient (API) that is chemically identical to the CBD present in Cannabis. ZYN002 is currently being evaluated in clinical trials in children and adolescents with Fragile X Syndrome (FXS), autism spectrum disorder, 22q11.2 deletion syndrome, and developmental and epileptic encephalopathies. The safety and efficacy of ZYN002 in the treatment of behavioral symptoms in children and adolescents with FXS has been evaluated in three studies: Study ZYN2-CL-009, a completed open-label, multiple-center, multiple-dose study (n=20); Study ZYN2-CL-016, a completed randomized, double-blind, placebo-controlled, multiple-center study (n=212 randomized); and Study ZYN2-CL-017, an ongoing open-label extension and expanded access study to assess the long-term safety and tolerability of ZYN002 (n=240). The present protocol for ZYN2-CL-033 (RECONNECT) is designed to evaluate the efficacy and safety of ZYN002 for the treatment and behavioral symptoms in children and adolescents with genetic evidence of full mutation FXS. Qualified subjects that complete ZYN2-CL-033 will have the opportunity to roll over to the open label ZYN2-CL-017 study.

Institution
Self Regional Healthcare
Recruitment Contact
Sarah English
8646726912
senglish@ggc.org

In Our DNA SC: A Helix Research Network Study

Date Added
October 19th, 2021
PRO Number
Pro00115183
Researcher
Daniel Judge

List of Studies


Keywords
Genetics, Healthy Volunteer Studies
Summary

The purpose of this project is to study DNA and its connection to your health. DNA is in your blood, your saliva, and other tissues in your body. DNA is the unique instructions you are born with that tells your body how to work. By looking at DNA, you can learn information about your health, certain traits, and even your ancestral roots. DNA is also called your genetic information. DNA is mostly the same from person to person. But everyone's DNA is slightly different. We are still learning how DNA impacts health. This study will look at the DNA of many different people from many different backgrounds and compare it to information in their health records. The goal is to understand how learning about DNA can help improve health care for individuals, families, and the community.

Participants will provide a sample for DNA sequencing. Sequencing is the process of reading the letters of your DNA. This study may sequence your whole genome. Over time, you may be asked to provide additional samples for research purposes. The research team will collect health information about you from your medical record and may ask you questions about your health using surveys or other data collection method.

Institution
MUSC
Recruitment Contact
Sarah English
(843) 876-0582
InOurDNASC@musc.edu

In Our DNA SC: A Helix Research Network Study

Date Added
October 19th, 2021
PRO Number
Pro00115183
Researcher
Daniel Judge

List of Studies


Keywords
Genetics, Healthy Volunteer Studies
Summary

The purpose of this project is to study DNA and its connection to your health. DNA is in your blood, your saliva, and other tissues in your body. DNA is the unique instructions you are born with that tells your body how to work. By looking at DNA, you can learn information about your health, certain traits, and even your ancestral roots. DNA is also called your genetic information. DNA is mostly the same from person to person. But everyone's DNA is slightly different. We are still learning how DNA impacts health. This study will look at the DNA of many different people from many different backgrounds and compare it to information in their health records. The goal is to understand how learning about DNA can help improve health care for individuals, families, and the community.

Participants will provide a sample for DNA sequencing. Sequencing is the process of reading the letters of your DNA. This study may sequence your whole genome. Over time, you may be asked to provide additional samples for research purposes. The research team will collect health information about you from your medical record and may ask you questions about your health using surveys or other data collection method.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Sarah English
(843) 876-0582
InOurDNASC@musc.edu

In Our DNA SC: A Helix Research Network Study

Date Added
October 19th, 2021
PRO Number
Pro00115183
Researcher
Daniel Judge

List of Studies


Keywords
Genetics, Healthy Volunteer Studies
Summary

The purpose of this project is to study DNA and its connection to your health. DNA is in your blood, your saliva, and other tissues in your body. DNA is the unique instructions you are born with that tells your body how to work. By looking at DNA, you can learn information about your health, certain traits, and even your ancestral roots. DNA is also called your genetic information. DNA is mostly the same from person to person. But everyone's DNA is slightly different. We are still learning how DNA impacts health. This study will look at the DNA of many different people from many different backgrounds and compare it to information in their health records. The goal is to understand how learning about DNA can help improve health care for individuals, families, and the community.

Participants will provide a sample for DNA sequencing. Sequencing is the process of reading the letters of your DNA. This study may sequence your whole genome. Over time, you may be asked to provide additional samples for research purposes. The research team will collect health information about you from your medical record and may ask you questions about your health using surveys or other data collection method.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Sarah English
(843) 876-0582
InOurDNASC@musc.edu

In Our DNA SC: A Helix Research Network Study

Date Added
October 19th, 2021
PRO Number
Pro00115183
Researcher
Daniel Judge

List of Studies


Keywords
Genetics, Healthy Volunteer Studies
Summary

The purpose of this project is to study DNA and its connection to your health. DNA is in your blood, your saliva, and other tissues in your body. DNA is the unique instructions you are born with that tells your body how to work. By looking at DNA, you can learn information about your health, certain traits, and even your ancestral roots. DNA is also called your genetic information. DNA is mostly the same from person to person. But everyone's DNA is slightly different. We are still learning how DNA impacts health. This study will look at the DNA of many different people from many different backgrounds and compare it to information in their health records. The goal is to understand how learning about DNA can help improve health care for individuals, families, and the community.

Participants will provide a sample for DNA sequencing. Sequencing is the process of reading the letters of your DNA. This study may sequence your whole genome. Over time, you may be asked to provide additional samples for research purposes. The research team will collect health information about you from your medical record and may ask you questions about your health using surveys or other data collection method.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Sarah English
(843) 876-0582
InOurDNASC@musc.edu

The RESTORE ("REducing future fractureS and improving ouTcOmes of fRagility fracturE") Protocol will serve as the written guidelines for study processes and procedures.

Date Added
March 25th, 2026
PRO Number
Pro00149331
Researcher
Jyotika Fernandes

List of Studies


Keywords
Bone
Summary

This study will recruit 2,634 participants,50 years of age or older, who have sustained a primary fragility fracture of the hip, femur, pelvis, clinical spine, humerus, or wrist in the last 12 months. Participants will be recruited from approximately 20 sites around the United States. Patients will be randomized to either continue treatment with "Augmented Fracture Liaison Service" or to continue with "Enhanced Usual Care." Both pathways incorporate patient education about the high risk of future fractures and available treatment approaches for fracture risk reduction. Patient education materials, in English or Spanish, will include information about fractures, bone health and osteoporosis, and will refer participants to resources to provide additional education on ways to reduce the risk of another fracture. Both arms of the study will be mailed education materials after enrollment. Study participation will consist of surveys over the course of 2 years, and a visit to a bone health specialist.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu



-- OR --