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Sargramostim for Down Syndrome
Study Summary
This trial will test if a drug is safe and tolerated by young adults with Down Syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had seizures, not including fever-related ones as a baby.My liver isn't working well, or my ALT levels are three times higher than normal.I am between 18-35 years old and have Down syndrome.Your blood pressure is higher than 160 over 95 when checked before the study.My kidney function is impaired with high creatinine or low GFR.My medications have been the same for the last 30 days.I have had my spleen removed or it does not work properly.You have tested positive for hepatitis B, hepatitis C, HIV, or syphilis.I have been diagnosed with Down syndrome.I have a history of blood clots in my veins or lungs.I don't have any health issues that would affect the study or need treatments that could alter my immune system.You have signs of fluid buildup in your body before joining the study.I regularly take an anti-cholinergic drug more than twice a week.I haven't taken any experimental drugs recently.I can give my consent or have someone legally authorized to do so on my behalf.I can see and hear well enough to participate in the trial.I've been tested for hypothyroidism in the last 6 months and am stable on my medication.I regularly take NSAIDs, but not more than 81 mg of aspirin daily.I have a caregiver who can be with me for at least 12 hours a week and come to my appointments.I have moderate to severe lung problems like COPD.Your heart rate is less than 50 beats per minute when checked by the study doctor.Your heart's electrical activity stays elevated for too long, especially if you are a female with a QTc interval greater than 470 ms, or a male with a QTc interval greater than 450 ms.I have heart problems that need treatment.I have difficult veins for drawing blood.I haven't had cancer, except for non-dangerous skin cancer, in the last 5 years.You have had severe allergic reactions to drugs or ingredients in the study medication.I am not pregnant, breastfeeding, and use effective birth control or am surgically sterilized.I have not received a live vaccine in the last six weeks and do not plan to during the study.You have had an allergic reaction to latex or yeast in the past.I am currently taking medications that suppress my immune system.
- Group 1: Sargramostim
- Group 2: Placebo Control - Saline
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is Sargramostim for Injection a safe option for patients to utilize?
"Reassessment of safety data has given Sargramostim for Injection a score of 2, as there is evidence to indicate its harmlessness but none yet suggesting it works."
Are elderly patients eligible to participate in this particular clinical trial?
"This research is seeking out participants who have exceeded the age of consent yet remain younger than 35."
Are there currently any vacancies for individuals to partake in this clinical trial?
"Clinicaltrials.gov confirms that this clinical trial, which was initially uploaded on January 1st 2023 and modified lastly on November 9th 2022, is no longer recruiting patients. Luckily, 1387 other studies are presently in the process of accepting volunteers."
Are there any criteria for selection regarding who can partake in this clinical investigation?
"Eligibility criteria for this research stipulates that participants should have down syndrome and be 18 to 35 years of age. Currently, the project is aiming to enlist approximately 42 individuals."
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