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Chelating Agent
1 for Lead Poisoning
Phase 3
Waitlist Available
Led By Walter Rogan, M.D.
Research Sponsored by National Institute of Environmental Health Sciences (NIEHS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The study population will reflect the population known to be at greatest risk to lead exposure, i.e., low income, urban, African-American children.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up annually
Awards & highlights
Summary
The Treatment of Lead-Exposed Children (TLC) clinical trial compared the effect of lead chelation with succimer to placebo therapy. TLC was a randomized, double-blind, placebo-controlled clinical trial with sites in Cincinnati and Columbus, Ohio, Philadelphia, Pennsylvania, Baltimore, Maryland and Newark, New Jersey. The study was designed to test outcomes in IQ, neuropsychological function, behavior, physical growth and blood pressure three years after initiation of treatment. Enrollment was conducted between 1994 and 1997, with completion of the initial three-year follow-up in 2000.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ annually
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~annually
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Scuccimer Treatment Group
Group II: 2Placebo Group1 Intervention
In order to provide placebo with an odor comparable to that of succimer, the Drug Distribution Center will place a small canister containing 200 mg of active drug into each bottle of placebo drug. A canister containing 200 mg of placebo will be placed inside each bottle of succimer so that all bottles will appear the same.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Succimer
FDA approved
Find a Location
Who is running the clinical trial?
National Institute of Environmental Health Sciences (NIEHS)Lead Sponsor
286 Previous Clinical Trials
1,231,873 Total Patients Enrolled
10 Trials studying Lead Poisoning
5,249 Patients Enrolled for Lead Poisoning
Walter Rogan, M.D.Principal InvestigatorNational Institute of Environmental Health Sciences (NIEHS)
2 Previous Clinical Trials
396 Total Patients Enrolled
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