NCT06091332RecruitingPhase 2
Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial
Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: a Randomized, Placebo-controlled Pilot Trial
Source: ClinicalTrials.gov · Last updated 20 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 13 Oct 2023
- Start date
- 5 Jan 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Huashan Hospital
- Diseases
- Stroke
- NCT number
- NCT06091332
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 75
- From 5 Jan 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous immunosuppressive therapy;
- History of prior surgical intervention for CCM ;
- History of prior cranial radiation therapy ;
- Patients with concurrent acute active infections (e.g., severe bacterial, viral, or fungal infections);
- Co-administration of drugs affecting CYP3A4 enzymes (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin).
Other illness
- Cancer history;
- Sirolimus/starch allergy;
- Modified Rankin Scale (mRS) score 5, respiratory failure or currently severe bleeding requiring life support treatment;
- Uncontrolled diabetes mellitus;
Lab values
- 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 normal values, platelet count below 100 or above 300);
Other
- Pregnancy or lactation;
- Familial CCM or people with multiple CCM;
- Currently participating in another clinical trial;
- Patient unwilling/unable to undergo MRI.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.