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New treatment option for Cavernous Malformations
Official title Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial
ClinicalTrials.gov ID: NCT06091332
What this study is testing
What is Sirolimus?
Sirolimus is an investigational medicine, being studied as a potential treatment for cavernous malformations.
Also referred to as Rapamycin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this pilot phase trial is to assess the safety and tolerability, and estimate the efficacy of sirolimus in reducing the incidence of ICH during high-risk periods for rebleeding, compared to placebo. This pilot trial will inform the design of a future definitive clinical trial on sirolimus treatment for CCM.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age 18-65 years, any gender;
- Patients who have experienced their first symptomatic BSCM ICH within the six months before randomisation;
- Diagnosed with solitary BSCM through T2, GRE/T2\ , or SWI MR imaging;
- ICH within or around the BSCM confirmed by CT /MR;
- Capable of signing an informed consent form with the accompaniment and understanding of a guardian.
You likely can't join if
- Cancer history;
- Pregnancy or lactation;
- Sirolimus/starch allergy;
- Modified Rankin Scale (mRS) score 5, respiratory failure or currently severe bleeding requiring life support treatment;
- Abnormal liver and/or kidney function (transaminase levels greater than 50, creatinine greater than 110), abnormal white blood cell/platelet counts...
- History of previous immunosuppressive therapy;
See the full eligibility criteria
- Age 18-65 years, any gender;
- Patients who have experienced their first symptomatic BSCM ICH within the six months before randomisation;
- Diagnosed with solitary BSCM through T2, GRE/T2\ , or SWI MR imaging;
- ICH within or around the BSCM confirmed by CT /MR;
- Capable of signing an informed consent form with the accompaniment and understanding of a guardian.
- Cancer history;
- Pregnancy or lactation;
- Sirolimus/starch allergy;
- Modified Rankin Scale (mRS) score 5, respiratory failure or currently severe bleeding requiring life support treatment;
- Abnormal liver and/or kidney function (transaminase levels greater than 50, creatinine greater than 110), abnormal white blood cell/platelet counts (white blood cell count below 3.5 or above 9.5 x 109/L or exceeding...
- History of previous immunosuppressive therapy;
- History of prior surgical intervention for CCM ;
- History of prior cranial radiation therapy ;
- Familial CCM or people with multiple CCM;
- Patients with concurrent acute active infections (e.g., severe bacterial, viral, or fungal infections);
- Uncontrolled diabetes mellitus;
- Currently participating in another clinical trial;
- Patient unwilling/unable to undergo MRI.
- Co-administration of drugs affecting CYP3A4 enzymes (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin).
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.