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crizanlizumab for Priapism (SPARTAN Trial)
SPARTAN Trial Summary
This trial is testing a medication to see if it can help treat priapism in people with sickle cell disease.
- Priapism
SPARTAN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SPARTAN Trial Design
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Who is running the clinical trial?
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- You have taken medications in the past 14 weeks that could cause a prolonged and painful erection.You had a prolonged erection lasting more than 12 hours in the 14 weeks before joining the study.You had an erection that lasted longer than 12 hours within the past 12 weeks.You have had at least 3 instances of prolonged and unwanted erections lasting for at least 60 minutes within a 12-week period, with at least 1 occurrence happening within 4 weeks before starting the treatment.You have had 4 or more prolonged, unwanted erections lasting at least 60 minutes in the 14 weeks before joining the study.
- Group 1: Crizanlizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
In how many different hospitals is this trial taking place?
"To limit the amount of travel required for participants, this study is enrolling at 19 sites which are primarily located in Atlanta, New york and Boston with a few other clinics around these cities."
Is this study enrolling new participants at the moment?
"The study is recruiting patients, as seen on clinicaltrials.gov. This information was first posted on October 16th, 2019 and last updated November 16th, 2021."
Are there other examples where crizanlizumab has been used in medical trials?
"There are currently 10 ongoing crizanlizumab clinical trials, 1 of which is in Phase 3. Greenville, South carolina hosts many of these studies; however, there are 400 research sites for this medication across the United States."
How many participants will this trial have in total?
"In order to move forward, this clinical trial requires 56 patients that adhere to the pre-specified inclusion criteria. Those that qualify can participate in this trial from multiple locations, such as Childrens Healthcare of Atlanta or NYC H Hospital Queens Cancer Center."
Could you explain the dangers associated with crizanlizumab?
"There is currently some data supporting the safety of crizanlizumab, but none yet indicating that it is an effective medication. Therefore, we have given it a score of 2."
To your knowledge, does a similar study exist?
"According to data that is currently available, there have been 10 different clinical trials for crizanlizumab. These trials were spread out over 144 cities and 36 countries with the earliest one taking place in 2017. The first trial was sponsored by Novartis Pharmaceuticals and had 57 participants. This study completed its Phase 2 drug approval stage in 2017 and 1 additional trial has been conducted since then."
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