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Trial record 3 of 12 for:    SYCAMORE

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 : September 22, 2022
Sponsor:
Information provided by (Responsible Party):
Recursion Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE October 8, 2021
First Posted Date  ICMJE October 20, 2021
Last Update Posted Date September 22, 2022
Actual Study Start Date  ICMJE March 17, 2022
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2021)
  • Incidence and severity of adverse events (AEs) [ Time Frame: 12 months ]
    Safety and tolerability
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Symptomatic Cerebral Cavernous Malformation Trial of REC-994
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Cavernous Malformation
Intervention  ICMJE
  • Drug: REC-994
    REC-994 200 mg tablets
  • Drug: Placebo
    Placebo Tablets
Study Arms  ICMJE
  • Active Comparator: REC-994 200 mg
    REC-994 200 mg po once daily (QD) (1 200 mg REC-994 tablet, 1 matching placebo tablet)
    Interventions:
    • Drug: REC-994
    • Drug: Placebo
  • Active Comparator: REC-994 400 mg
    REC-994 400 mg po QD (2 200 mg REC-994 tablets)
    Intervention: Drug: REC-994
  • Placebo Comparator: Placebo
    Matching Placebo po QD (2 matching placebo tablets)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 8, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recursion Pharmaceuticals 385-374-1724 clinicaltrials@recursionpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05085561
Other Study ID Numbers  ICMJE REC-994-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Recursion Pharmaceuticals Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Recursion Pharmaceuticals Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Recursion Pharmaceuticals Inc.
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP