600 Participants Needed

Natural History Study for Genetic Disorders

Recruiting at 4 trial locations
PV
JN
VC
Overseen ByVictoria Chisari, BA, NS
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand disorders related to the STXBP1 and SYNGAP1 genes. Researchers will gather information on how these conditions affect development, seizures, and quality of life to aid in designing future treatment trials. The study includes two groups: one for individuals with STXBP1-related disorders and another for those with SYNGAP1-related disorders. Individuals with a confirmed mutation in either the STXBP1 or SYNGAP1 gene who experience related symptoms might be suitable candidates for this trial.

As an unphased study, this trial offers a unique opportunity to contribute to foundational research that could lead to new treatments.

Why are researchers excited about this trial?

Researchers are excited about the STXBP1 and SYNGAP1 related disorders natural history study because it aims to gather invaluable data about the progression and characteristics of these rare genetic disorders. Unlike treatments that focus on alleviating symptoms, this study seeks to understand the underlying mechanisms of these conditions over time. By doing so, it lays the groundwork for developing targeted therapies that could offer more effective, personalized treatment options in the future. The insights gained from this study could revolutionize how these disorders are approached and treated, potentially leading to breakthroughs in medical care for affected individuals.

Who Is on the Research Team?

IH

Ingo Helbig, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

Inclusion Criteria

My gender does not affect my eligibility.
I have a confirmed STXBP1 or SYNGAP1 gene mutation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including health and medical history, physical exams, EEG/qEEG, and neurodevelopmental and behavioral assessments

1 visit
1 visit (in-person)

Follow-up Assessments

Participants undergo semi-annual assessments to evaluate changes in neurodevelopmental and behavioral parameters, quality of life, and healthcare resource utilization

Every 6 months for 2-5 years
Up to 10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main study period

6 months

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: SYNGAP1 cohortExperimental Treatment1 Intervention
Group II: STXBP1 cohortExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

STXBP1 Foundation

Collaborator

Trials
2
Recruited
450+