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REC-994 for Cerebral Cavernous Malformations (SYCAMORE Trial)

Phase 2
Waitlist Available
Research Sponsored by Recursion Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older with anatomic CCM lesions demonstrated by brain MRI
Have symptomatic CCM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months (part 1)
Awards & highlights

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.

Who is the study for?
This trial is for adults with symptomatic cerebral cavernous malformation (CCM) confirmed by MRI. Participants must consent to the study and not have been in another drug trial within the past 28 days or 5 half-lives of any investigational drug. Exclusions include pregnancy, breastfeeding, inability to undergo MRI, liver or severe kidney issues, recent hemorrhage or brain surgery, history of muscle disorders or substance abuse.Check my eligibility
What is being tested?
The study tests REC-994 at two doses (200 mg and 400 mg) against a placebo in people with CCM. It's randomized and double-blind, meaning participants are put into groups by chance and neither they nor the researchers know who gets the real treatment versus placebo.See study design
What are the potential side effects?
While specific side effects for REC-994 aren't listed here, common ones in trials may include headaches, nausea, allergic reactions or other symptoms depending on how it affects individuals differently.

SYCAMORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and have CCM lesions in my brain shown by MRI.
Select...
I have symptoms from cerebral cavernous malformations.
Select...
I haven't been in a drug trial for at least 28 days or 5 half-lives of the drug.

SYCAMORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months (part 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months (part 1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events (AEs)
Secondary outcome measures
Change in disease-associated symptoms (number of MRI-confirmed cerebral hemorrhagic events)
Change in disease-associated symptoms (size and number of lesions on MRI)
Change in patient reported outcomes (Cerebral Cavernous Malformation Health Index)
+3 more

SYCAMORE Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: REC-994 200 mgActive Control2 Interventions
REC-994 200 mg po once daily (QD) (1 200 mg REC-994 tablet, 1 matching placebo tablet)
Group II: REC-994 400 mgActive Control1 Intervention
REC-994 400 mg po QD (2 200 mg REC-994 tablets)
Group III: PlaceboPlacebo Group1 Intervention
Matching Placebo po QD (2 matching placebo tablets)

Find a Location

Who is running the clinical trial?

Recursion Pharmaceuticals Inc.Lead Sponsor
3 Previous Clinical Trials
225 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05085561 — Phase 2
Cerebral Cavernous Malformations Research Study Groups: REC-994 200 mg, REC-994 400 mg, Placebo
Cerebral Cavernous Malformations Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05085561 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05085561 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~28 spots leftby Dec 2025