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REC-994 for Cerebral Cavernous Malformations (SYCAMORE Trial)
SYCAMORE Trial Summary
This trial is testing a new drug, REC-994, to see if it is safe and effective in treating people with a brain condition called CCM. The trial is randomized, meaning participants are assigned by chance to receive either the drug or a placebo. Double-blind means that neither the participants nor the researchers will know who is receiving the drug or the placebo.
SYCAMORE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSYCAMORE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SYCAMORE Trial Design
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Who is running the clinical trial?
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- I am over 18 and have CCM lesions in my brain shown by MRI.My liver tests are more than twice the normal limit.I cannot or do not want to undergo MRI scans due to claustrophobia or having a metal implant/pacemaker.My symptoms are due to permanent nerve damage from a past stroke or brain surgery.My kidney function is low, I have kidney disease, or I've had a kidney transplant.I have had brain radiation or surgery for a primary CCM lesion.I have symptoms from cerebral cavernous malformations.You have a major abnormality in your lab test results that could affect your health.I haven't had a brain bleed or surgery (except for my main CCM lesion) in the recent months.I haven't been in a drug trial for at least 28 days or 5 half-lives of the drug.You have had problems with drinking alcohol or using drugs in the past year.I have a muscle disorder or my muscle enzyme levels are very high.
- Group 1: REC-994 200 mg
- Group 2: REC-994 400 mg
- Group 3: Placebo
- 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 this an experimental medical research endeavor?
"As of now, only one active REC-994 400 mg trial is occurring across 11 cities and 1 nation. Commencing in 2022, this trial sponsored by Recursion Pharmaceuticals Inc., had 60 participants who completed the Phase 2 drug approval process. Since 2022, a total of 18326 studies have been finished."
How many geographic areas are offering this research trial?
"Columbia University in New york, University of Pittsburgh in Pittsburgh, and The University of Texas Southwestern Medical Center are among the 13 clinical trial sites recruiting patients for this medical study. Additionally, there are 10 other locales currently participating."
Has the FDA sanctioned a 400 mg dosage of REC-994?
"Our team at Power assigned a score of 2 to REC-994 400 mg based on their Phase 2 status; meaning that there is some evidence indicating its safety, yet none demonstrating efficacy."
Are there any comparable trials with REC-994 400 mg already conducted?
"Presently, only 1 clinical trial is actively researching the efficacy of REC-994 400 mg with no studies in Phase 3. While most research efforts are centralized around Gainesville, Florida, there exists 13 different sites conducting trials on this medication."
Are any additional participants being admitted to this clinical trial?
"Data recorded on clinicaltrials.gov reveals that this investigation is actively enrolling patients, having been posted on March 17th 2022 and revised most recently on November 29th."
How many participants are included in this investigation?
"Affirmative. According to clinicaltrials.gov, this medical experiment is searching for volunteers to participate and data was posted on March 17th 2022 with the last update being November 29th of that same year. Sixty individuals are required across 13 different sites."
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