A new DRUG TRIALS SNAPSHOT is now available.
Drug Trials Snapshots: FLUORODOPA F 18
FLUORODOPA F 18 is a drug for the visual detection of certain nerve cells in adult patients with suspected Parkinsonian Syndromes (PS).
PS is a group of movement disorders characterized by slow movements, body stiffness, shakiness at rest and inability to maintain posture. It is associated with the damage/loss of dopaminergic nerves in one part of the brain (called striatum).
FLUORODOPA F 18 is injected into a vein (intravenous) in preparation for an imaging test (called Positron Emission Tomography scan or PET scan) to help detect the damaged or lost dopaminergic nerve cells. It is to be used in addition to other tests for diagnosing the PS.
See more Drug Trials Snapshots or contact us with questions at Snapshots@fda.hhs.gov.
FLUORODOPA F 18
The Feinstein Institutes for Medical Research
Approval date: October 10, 2019
The Feinstein Institutes for Medical Research
Approval date: October 10, 2019
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
FLUORODOPA F 18 is a drug for the visual detection of certain nerve cells in adult patients with suspected Parkinsonian Syndromes (PS).
PS is a group of movement disorders characterized by slow movements, body stiffness, shakiness at rest and inability to maintain posture. It is associated with the damage/loss of dopaminergic nerves in one part of the brain (called striatum).
How is this drug used?
FLUORODOPA F 18 is injected into a vein (intravenous) in preparation for an imaging test (called Positron Emission Tomography scan or PET scan) to help detect the damaged or lost dopaminergic nerve cells. It is to be used in addition to other tests for diagnosing the PS.
What are the benefits of this drug?
Brain images made with FLUORODOPA F 18 make clinical diagnosis of PS more certain.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: FLUORODOPA F 18 worked similarly in men and women.
- Race: Data not collected.
- Age: FLUORODOPA F 18 worked similarly in patients younger and those older than 65 years of age.
What are the possible side effects?
FLUORODOPA F 18 is a radioactive drug which may increase the risk of lifetime radiation exposure.
Were there any differences in side effects among sex, race and age?
No side effects were reported in clinical trial; therefore, subgroup differences could not be evaluated.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved FLUORODOPA F 18 based on evidence from one clinical trial of 56 patients with suspected PS. The trial was conducted at one clinical site in the United States.
The figure below summarizes how many men and women were in the clinical trial.
Clinical Trial Data
Baseline Demographics by Race-data not collected
Figure 2 summarizes the percentage of patients by age group in the clinical trial.
Figure 2. Baseline Demographics by Age
Clinical Trial Data
How were the trials designed?
The benefit and side effect of FLUORODOPA F 18 were evaluated in one clinical trial of 56 patients with suspected PS. All patients received a single intravenous dose of FLUORODOPA F 18 before getting PET scan. PET scan Images were read by three readers who had no knowledge about patient’s condition.
The benefit was assessed by comparing the accuracy of FLUORODOPA F 18 images to detect nerve damage/loss with clinical diagnosis of PS 6-9 months after imaging.
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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