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The Symptomatic Cerebral Cavernous Malformation Trial of REC-994 (SYCAMORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05085561
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
Recursion Pharmaceuticals Inc.

Study Description
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Brief Summary:
This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the safety, efficacy and pharmacokinetics of REC-994 (200 mg and 400 mg) compared to placebo in subjects with symptomatic cerebral cavernous malformation (CCM).

Condition or disease Intervention/treatment Phase
Cerebral Cavernous Malformation Drug: REC-994 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of REC-994 in the Treatment of Symptomatic Cerebral Cavernous Malformation
Actual Study Start Date : March 17, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: REC-994 200 mg
REC-994 200 mg po once daily (QD) (1 200 mg REC-994 tablet, 1 matching placebo tablet)
 Drug: REC-994
REC-994 200 mg tablets

Drug: Placebo
Placebo Tablets
Active Comparator: REC-994 400 mg
REC-994 400 mg po QD (2 200 mg REC-994 tablets)
 Drug: REC-994
REC-994 200 mg tablets
Placebo Comparator: Placebo
Matching Placebo po QD (2 matching placebo tablets)
 Drug: Placebo
Placebo Tablets


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of adverse events (AEs) [ Time Frame: 12 months ]
    Safety and tolerability

  2. Incidence of clinically significant changes in laboratory assessments (hematology, chemistry, coagulation, and urinalysis), 12-lead ECGs, vital sign measurements, and physical examinations. [ Time Frame: 12 months ]
    Safety and tolerability


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. 18 years of age or older with anatomic CCM lesions demonstrated by brain MRI
  2. Have symptomatic CCM
  3. Have provided written informed consent to participate in the study
  4. Have NOT participated in a clinical trial utilizing an investigational agent within 28 days or within 6 half-lives of the investigational drug (whichever is longer) prior to Screening

Exclusion Criteria:

  1. Symptoms deemed by the study Investigator to be caused exclusively by irreversible neuronal damage from prior stroke or neurosurgical instrumentation
  2. History of cranial irradiation or surgical/radiosurgical treatment of the primary symptomatic CCM lesion
  3. Pregnant or breast feeding
  4. Be unable or unwilling to participate in MRI assessments (eg, claustrophobia, metal implant or implanted cardiac pacemaker)
  5. Liver dysfunction or active liver disease as defined by baseline serum transaminases >2x upper limit of normal (ULN)
  6. Have severely impaired renal function (eGFR <60ml/min) or active renal disease
  7. Have had a previous diagnosis of skeletal muscle disorders (myopathy) of any cause or have a baseline creatine kinase level > 5x ULN
  8. History of alcohol or substance abuse within 1 year prior to screening
  9. Clinically significant laboratory abnormality
  10. Have had an intracerebral hemorrhage within 3 months of screening or any brain surgery within 6 months of screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085561


Contacts
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Contact: Recursion Pharmaceuticals 385-374-1724 clinicaltrials@recursionpharma.com

Locations
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United States, Arizona
Xenoscience Inc Recruiting
Phoenix, Arizona, United States, 85004
Contact: Mona Dever    602-274-9500    mdever@xenoscience.com   
Contact: Meaghan Geiger       mgeiger@xenoscience.com   
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Melissa Arevalo    310-794-3788    mfarevalo@mednet.ucla.edu   
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Sasha Alexander    650-497-3968    sashalex@stanford.edu   
Contact: Guiping Qin       gqin68@stanford.edu   
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Jessica Spana       jessica.spana@neurology.ufl.edu   
Contact: Hans Shuhaiber, MD       hshuhaiber@ufl.edu   
Lyerly Neurosurgery Recruiting
Jacksonville, Florida, United States, 32207-8202
Contact: Jordan Oberhaus    904-202-7089    ordan.Oberhaus@bmcjax.com   
Contact: Eisley Charltray    904-202-7998    Eisley.Charltray@bmcjax.com   
United States, Georgia
Emory Recruiting
Atlanta, Georgia, United States, 30322
Contact: Yvan Bamps, PhD    404-778-7673    ybamps@emory.edu   
Contact: Emilee Wehunt    404-778-3746    emorga9@emory.edu   
United States, New Jersey
Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Naomi Hatulan    201-447-8453    nhatula@valleyhealth.com   
Contact: Kimberly Michel    201-447-8453    kmichel@valleyhealth.com   
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10027
Contact: Angela Velazquez    212-305-6071    agv2113@cumc.columbia.edu   
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nadirah Jones       nadirah.jones2@jefferson.edu   
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Leah Coghlan       NCRDNeuroICU@uphs.upenn.edu   
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Maegan Johnson    412-677-0243    johnsonme9@upmc.edu   
Contact: Sara Onesi    412-385-7711    onesisa2@upmc.edu   
United States, Texas
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8855
Contact: Tash Mupambo       tashinga.mupambo@UTSouthwestern.edu   
Contact: Emerson Nairon       emerson.nairon@UTsouthwestern.edu   
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Judy Beenhakker    434-982-1856    jgb3p@virginia.edu   
Sponsors and Collaborators
Recursion Pharmaceuticals Inc.
More Information
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Responsible Party: Recursion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT05085561    
Other Study ID Numbers: REC-994-201
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: February 24, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma, Cavernous, Central Nervous System
Congenital Abnormalities
Hemangioma, Cavernous
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Central Nervous System Vascular Malformations
Nervous System Malformations
 Nervous System Diseases
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Hemostatic Disorders
Vascular Diseases
Hemorrhagic Disorders
Hematologic Diseases