A Phase 2 interventional study of REC-994 and Placebo in Cerebral Cavernous Malformation, sponsored by Recursion Pharmaceuticals Inc.. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Recursion Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment
This is a two-part, 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 participants with symptomatic cerebral cavernous malformation (CCM).
Part 1: Participants will receive treatment over a period of 12 months. Part 2: Optional long-term extension (LTE) for participants completing Part 1 and who are eligible for extended treatment with REC-994.
Recursion Pharmaceuticals Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received REC-994 200 milligrams (mg) orally once daily (QD) (1 200 mg REC-994 tablet, 1 matching placebo tablet)
Drug: REC-994 · Drug: Placebo
Participants received REC-994 400 mg orally QD (2 200 mg REC-994 tablets)
Drug: REC-994
Participants received matching placebo orally QD (2 matching placebo tablets)
Drug: Placebo
REC-994 200 mg tablets
Placebo Tablets
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. TEAES which include treatment related TEAEs, serious TEAEs, treatment-related serious TEAEs, TEAEs leading to treatment discontinuation, and treatment-related TEAEs leading to treatment discontinuation are reported. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section
Time frame: Up to a maximum of 1201 days
Part 1: Change From Baseline in Modified Rankin Scale (mRS) Score at Month 12
The mRS is used for measuring the degree of disability or dependence in the daily activities of people who have suffered an acute stroke. The mRS score was calculated from a 6-point scale runs from 0-5, corresponding to no symptoms at all (0) to severe (5). A negative change from baseline indicated an improvement in symptoms. Change from baseline at Month 12 was analyzed by mixed model repeated measures (MMRM) method. The model included the change from baseline at visit as the dependent variable, with baseline score as covariate, treatment, visit, and treatment by visit interaction as fixed effects. Participant was included as a random effect using an unstructured covariance structure.
Time frame: Baseline, Month 12
Part 1: Change From Baseline in Total SymptoMScreen (SMSS) Score at Month 12
The SMSS questionnaire is a self-assessment tool consists of 12 critical neurologic items, each assessed on a seven-point Likert scale ranging from 0 (not at all affected) to 6 (total limitation). The total score ranged from 0 to 72, with higher scores indicating more severe symptoms. A negative change from baseline indicated an improvement in symptoms. Change from baseline at Month 12 was analyzed by MMRM method. The model included the change from baseline at visit as the dependent variable, with baseline score as covariate, treatment, visit, and treatment by visit interaction as fixed effects. Participant was included as a random effect using an unstructured covariance structure.
Time frame: Baseline, Month 12
Part 1: Change From Baseline in Cerebral Cavernous Malformation Health Index (CCM-HI) Total Score at Month 12
The CCM-HI is a novel patient-reported outcome to assess overall symptom burden across 20 domains. The total CCM-HI score was calculated as a weighted sum of subscale scores, with higher scores indicating greater disease burden. Subscale scores were derived by multiplying individual item responses (scored 0-4) by predefined weights and summing within each subscale. Each subscale score is then multiplied by a corresponding scaling factor. The weighted subscale scores were summed to generate a total score ranging from 0 to 100, with higher scores reflecting more severe symptoms. A negative change from baseline indicated an improvement in symptoms. Change from baseline at Month 12 were analyzed by MMRM method. The model included the change from baseline at visit as the dependent variable, with baseline score as covariate, treatment, visit, and treatment by visit interaction as fixed effects. Participant was included as a random effect using an unstructured covariance structure.
Time frame: Baseline, Month 12
Part 1: Clinical Global Impressions - Improvement (CGI-I) Scale Score at Month 12
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. The model included the CGI-I score at each visit as the dependent variable, with corresponding baseline score as covariate, treatment, visit, and treatment by visit interaction as fixed effects. Participant was included as a random effect using an unstructured covariance structure.
Time frame: Month 12
Part 1: Patient Global Impressions - Improvement (PGI-I) Scale Score at Month 12
The PGI is a 7-point scale that requires the participant to assess how much their own illness has improved or worsened relative to a baseline state at the beginning of the intervention and was rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. The model included the PGI-I score at each visit as the dependent variable, with corresponding baseline score as covariate, treatment, visit, and treatment by visit interaction as fixed effects. Participant was included as a random effect using an unstructured covariance structure.
Time frame: Month 12
Part 1: Change From Baseline in Number of Monthly Seizures at Month 12
Number of monthly seizures was calculated during each analysis window as follows: (number of observed seizures in each interval/number of days with seizure diary entry during each interval) x 30. Change from Baseline over monthly intervals was reported with a negative change indicating a reduction in the number of seizures.
Time frame: Baseline, Month 12
Part 1: Change From Baseline in Number of Monthly Headaches at Month 12
Number of monthly headaches was calculated during each analysis window as follows: (number of observed headaches in each interval/number of days with headache diary entry during each interval) x 30. Change from Baseline over monthly intervals was reported with a negative change indicating a reduction in the number of seizures.
Time frame: Baseline, Month 12
Number of Participants With Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) Confirmed Cerebral Haemorrhagic Events
MRI and/or CT scan were used to confirm evidence of symptomatic cerebral hemorrhagic events.
Time frame: Up to a maximum 1201 days
| Milestone | REC-994 200 mg (Parts 1 and 2) | REC-994 400 mg (Parts 1 and 2) | Placebo (Part 1) | Placebo Part 1, Then REC-994 200 mg Part 2 | Placebo Part 1, Then REC-994 400 mg Part 2 |
|---|---|---|---|---|---|
| Started | 21 | 21 | 20 | 0 | 0 |
| Completed | 19 | 20 | 18 | 0 | 0 |
| Not completed | 2 | 1 | 2 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 |
| Milestone | REC-994 200 mg (Parts 1 and 2) | REC-994 400 mg (Parts 1 and 2) | Placebo (Part 1) | Placebo Part 1, Then REC-994 200 mg Part 2 | Placebo Part 1, Then REC-994 400 mg Part 2 |
|---|---|---|---|---|---|
| Started | 16 | 18 | 0 | 8 | 7 |
| Completed | 16 | 15 | 0 | 8 | 6 |
| Not completed | 0 | 3 | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 1 |
| Withdrew: Sponsor terminated | 0 | 1 | 0 | 0 | 0 |
A TEAE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. TEAES which include treatment related TEAEs, serious TEAEs, treatment-related serious TEAEs, TEAEs leading to treatment discontinuation, and treatment-related TEAEs leading to treatment discontinuation are reported. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section
| Participants | REC-994 200 mg (Parts 1 and 2) | REC-994 400 mg (Parts 1 and 2) | Placebo (Part 1) | Placebo Part 1 Then REC-994 200mg Part 2 | Placebo Part 1 Then REC-994 400mg Part 2 |
|---|---|---|---|---|---|
| Treatment Emergent Adverse Events (TEAE) | 20 | 16 | 17 | 5 | 7 |
| Treatment Related TEAE | 0 | 5 | 2 | 0 | 2 |
| Serious TEAE | 2 | 3 | 4 | 1 | 2 |
| Treatment Related Serious TEAE | 0 | 0 | 0 | 0 | 0 |
| TEAEs Leading to Treatment Discontinuation | 1 | 1 | 1 | 0 | 0 |
| Treatment Related TEAEs leading to treatment discontinuation | 0 | 1 | 0 | 0 | 0 |
The mRS is used for measuring the degree of disability or dependence in the daily activities of people who have suffered an acute stroke. The mRS score was calculated from a 6-point scale runs from 0-5, corresponding to no symptoms at all (0) to severe (5). A negative change from baseline indicated an improvement in symptoms. Change from baseline at Month 12 was analyzed by mixed model repeated measures (MMRM) method. The model included the change from baseline at visit as the dependent variable, with baseline score as covariate, treatment, visit, and treatment by visit interaction as fixed effects. Participant was included as a random effect using an unstructured covariance structure.
| score on a scale | REC-994 200 mg (Part 1) | REC-994 400 mg (Part 1) | Placebo (Part 1) |
|---|---|---|---|
| Part 1: Change From Baseline in Modified Rankin Scale (mRS) Score at Month 12 | -0.1 ± 0.15 | -0.2 ± 0.16 | -0.1 ± 0.16 |
The SMSS questionnaire is a self-assessment tool consists of 12 critical neurologic items, each assessed on a seven-point Likert scale ranging from 0 (not at all affected) to 6 (total limitation). The total score ranged from 0 to 72, with higher scores indicating more severe symptoms. A negative change from baseline indicated an improvement in symptoms. Change from baseline at Month 12 was analyzed by MMRM method. The model included the change from baseline at visit as the dependent variable, with baseline score as covariate, treatment, visit, and treatment by visit interaction as fixed effects. Participant was included as a random effect using an unstructured covariance structure.
| score on a scale | REC-994 200 mg (Part 1) | REC-994 400 mg (Part 1) | Placebo (Part 1) |
|---|---|---|---|
| Part 1: Change From Baseline in Total SymptoMScreen (SMSS) Score at Month 12 | -0.7 ± 1.66 | -2.4 ± 1.80 | -0.5 ± 1.81 |
The CCM-HI is a novel patient-reported outcome to assess overall symptom burden across 20 domains. The total CCM-HI score was calculated as a weighted sum of subscale scores, with higher scores indicating greater disease burden. Subscale scores were derived by multiplying individual item responses (scored 0-4) by predefined weights and summing within each subscale. Each subscale score is then multiplied by a corresponding scaling factor. The weighted subscale scores were summed to generate a total score ranging from 0 to 100, with higher scores reflecting more severe symptoms. A negative change from baseline indicated an improvement in symptoms. Change from baseline at Month 12 were analyzed by MMRM method. The model included the change from baseline at visit as the dependent variable, with baseline score as covariate, treatment, visit, and treatment by visit interaction as fixed effects. Participant was included as a random effect using an unstructured covariance structure.
| score on a scale | REC-994 200 mg (Part 1) | REC-994 400 mg (Part 1) | Placebo (Part 1) |
|---|---|---|---|
| Part 1: Change From Baseline in Cerebral Cavernous Malformation Health Index (CCM-HI) Total Score at Month 12 | -5.8 ± 2.39 | -1.9 ± 2.53 | -7.8 ± 2.52 |
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. The model included the CGI-I score at each visit as the dependent variable, with corresponding baseline score as covariate, treatment, visit, and treatment by visit interaction as fixed effects. Participant was included as a random effect using an unstructured covariance structure.
| score on a scale | REC-994 200 mg (Part 1) | REC-994 400 mg (Part 1) | Placebo (Part 1) |
|---|---|---|---|
| Part 1: Clinical Global Impressions - Improvement (CGI-I) Scale Score at Month 12 | 3.1 ± 0.25 | 3.7 ± 0.27 | 3.1 ± 0.27 |
The PGI is a 7-point scale that requires the participant to assess how much their own illness has improved or worsened relative to a baseline state at the beginning of the intervention and was rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. The model included the PGI-I score at each visit as the dependent variable, with corresponding baseline score as covariate, treatment, visit, and treatment by visit interaction as fixed effects. Participant was included as a random effect using an unstructured covariance structure.
| score on a scale | REC-994 200 (Part 1) | REC-994 400 mg (Part 1) | Placebo (Part 1) |
|---|---|---|---|
| Part 1: Patient Global Impressions - Improvement (PGI-I) Scale Score at Month 12 | 3.1 ± 0.27 | 3.6 ± 0.28 | 3.1 ± 0.28 |
Number of monthly seizures was calculated during each analysis window as follows: (number of observed seizures in each interval/number of days with seizure diary entry during each interval) x 30. Change from Baseline over monthly intervals was reported with a negative change indicating a reduction in the number of seizures.
| Seizures per month | REC-994 200 mg (Part 1) | REC-994 400 mg (Part 1) | Placebo (Part 1) |
|---|---|---|---|
| Part 1: Change From Baseline in Number of Monthly Seizures at Month 12 | 1.1 ± 3.99 | -0.4 ± 1.41 | -0.2 ± 1.17 |
Number of monthly headaches was calculated during each analysis window as follows: (number of observed headaches in each interval/number of days with headache diary entry during each interval) x 30. Change from Baseline over monthly intervals was reported with a negative change indicating a reduction in the number of seizures.
| Headaches per month | REC-994 200 mg (Part 1) | REC-994 400 mg (Part 1) | Placebo (Part 1) |
|---|---|---|---|
| Part 1: Change From Baseline in Number of Monthly Headaches at Month 12 | -3.5 ± 5.87 | -7.5 ± 11.07 | -7.1 ± 9.51 |
MRI and/or CT scan were used to confirm evidence of symptomatic cerebral hemorrhagic events.
| Participants | REC-994 200 mg (Parts 1 and 2) | REC-994 400 mg (Parts 1 and 2) | Placebo (Part 1) | Placebo Part 1 Then REC-994 200mg Part 2 | Placebo Part 1 Then REC-994 400mg Part 2 |
|---|---|---|---|---|---|
| Number of Participants With Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) Confirmed Cerebral Haemorrhagic Events | 2 | 2 | 3 | 1 | 1 |
Collected over Up to a maximum of 1201 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| REC-994 200 mg (Parts 1 and 2) | 0/21 (0%) | 2/21 (9.5%) | 20/21 (95.2%) |
| REC-994 400 mg (Parts 1 and 2) | 0/21 (0%) | 3/21 (14.3%) | 16/21 (76.2%) |
| Placebo (Part 1) | 0/20 (0%) | 4/20 (20%) | 16/20 (80%) |
| Placebo Part 1 Then REC-994 200mg Part 2 | 0/8 (0%) | 1/8 (12.5%) | 4/8 (50%) |
| Placebo Part 1 Then REC-994 400mg Part 2 | 0/7 (0%) | 2/7 (28.6%) | 6/7 (85.7%) |
| Event | REC-994 200 mg (Parts 1 and 2) | REC-994 400 mg (Parts 1 and 2) | Placebo (Part 1) | Placebo Part 1 Then REC-994 200mg Part 2 | Placebo Part 1 Then REC-994 400mg Part 2 |
|---|---|---|---|---|---|
| Vasogenic cerebral oedemaNervous system disorders | 0/21 | 0/21 | 0/20 | 0/8 | 1/7 |
| DiplopiaEye disorders | 0/21 | 0/21 | 0/20 | 0/8 | 1/7 |
| Nervous system disorderNervous system disorders | 0/21 | 0/21 | 0/20 | 1/8 | 0/7 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/21 | 0/21 | 1/20 | 0/8 | 0/7 |
| Brain oedemaNervous system disorders | 0/21 | 0/21 | 1/20 | 0/8 | 0/7 |
| Brain stem haemorrhageNervous system disorders | 0/21 | 0/21 | 1/20 | 0/8 | 0/7 |
| Cerebral infarctionNervous system disorders | 0/21 | 0/21 | 1/20 | 0/8 | 0/7 |
| Spinal cord haemorrhageNervous system disorders | 0/21 | 0/21 | 1/20 | 0/8 | 0/7 |
| Spinal cord oedemaNervous system disorders | 0/21 | 0/21 | 1/20 | 0/8 | 0/7 |
| BacteraemiaInfections and infestations | 0/21 | 0/21 | 1/20 | 0/8 | 0/7 |
| Event | REC-994 200 mg (Parts 1 and 2) | REC-994 400 mg (Parts 1 and 2) | Placebo (Part 1) | Placebo Part 1 Then REC-994 200mg Part 2 | Placebo Part 1 Then REC-994 400mg Part 2 |
|---|---|---|---|---|---|
| COVID-19Infections and infestations | 5/21 | 6/21 | 1/20 | 0/8 | 0/7 |
| NauseaGastrointestinal disorders | 2/21 | 1/21 | 1/20 | 0/8 | 2/7 |
| FatigueGeneral disorders | 1/21 | 1/21 | 0/20 | 2/8 | 0/7 |
| HeadacheNervous system disorders | 3/21 | 3/21 | 1/20 | 0/8 | 1/7 |
| DizzinessNervous system disorders | 2/21 | 3/21 | 1/20 | 0/8 | 1/7 |
| HypoaesthesiaNervous system disorders | 3/21 | 1/21 | 1/20 | 0/8 | 0/7 |
| Brain stem microhaemorrhageNervous system disorders | 0/21 | 0/21 | 0/20 | 0/8 | 1/7 |
| HemiparesisNervous system disorders | 0/21 | 0/21 | 0/20 | 0/8 | 1/7 |
| Respiratory tract infection viralInfections and infestations | 0/21 | 0/21 | 0/20 | 0/8 | 1/7 |
| DepressionPsychiatric disorders | 0/21 | 3/21 | 1/20 | 0/8 | 1/7 |
Full Analysis Set (FAS), included all participants randomly assigned to a treatment group on Day 1 of Part 1 and have at least one efficacy assessment after randomization in Part 1.
| Age, Continuous(years) | REC-994 200 mg | REC-994 400 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 46.6 ± 14.52 | 48.9 ± 10.82 | 47.1 ± 15.78 | 47.5 ± 13.64 |
| Sex: Female, Male(Participants) | REC-994 200 mg | REC-994 400 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 9 | 16 | 14 | 39 |
| Male | 12 | 5 | 6 | 23 |
| Race (NIH/OMB)(Participants) | REC-994 200 mg | REC-994 400 mg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 1 | 1 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 1 | 3 |
| White | 18 | 17 | 17 | 52 |
| More than one race | 0 | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | REC-994 200 mg | REC-994 400 mg | Placebo | Total |
|---|---|---|---|---|
| United States | 21 | 21 | 20 | 62 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2022 to primary completion in Jun 2025, 39 months.
Results were first posted in Oct 2026, 1 year 3 months after primary completion. A results delay was requested in Jun 2026.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Hemangioma, Cavernous, Central Nervous System
Recursion Pharmaceuticals Inc.