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Tests treatment safety and results for Cerebral AV Malformation
Official title Efficacy and Safety of Anti-angiogenic Therapy With IV Bevacizumab in Patients With Symptomatic Cerebral Arteriovenous Malformations
ClinicalTrials.gov ID: NCT06264531
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cerebral av malformation.
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
- Brain arteriovenous malformations (AVMs) are responsible for hemorrhagic strokes, particularly in children and young adults. They can also be responsible for chronic neurological disorders: motor or sensory deficits, disturbances of higher functions, epilepsy or disabling headaches.
- Phase 3: a large, late-stage study
- Which group you join is 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 and older
You may be able to join if
- Patient over 18 years of age
- With a symptomatic cerebral AVM (chronic headache, focal neurological deficit, cognitive impairment, epilepsy) of Spetzler and Martin grade III, IV...
- Whose symptoms are sufficiently severe to allow significant improvement with treatment:
- MoCA score ≤ 25 and/or
- NIHSS score ≥ 4 and/or
You likely can't join if
- Known allergy to bevacizumab or an excipient.
- Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies.
- Contraindication to cerebral MRI
- Absolute or relative contraindication to gadolinium injection
- Proteinuria ≥ 2+ on urine dipstick (patients with proteinuria ≥2+ on urine dipstick will need to have proteinuria ≤ 1g protein on 24-hour urine to be...
- Uncontrolled hypertension (PAS \>150 and/or PAD \> 100 mmHg)
See the full eligibility criteria
- Patient over 18 years of age
- With a symptomatic cerebral AVM (chronic headache, focal neurological deficit, cognitive impairment, epilepsy) of Spetzler and Martin grade III, IV or V.
- Whose symptoms are sufficiently severe to allow significant improvement with treatment:
- MoCA score ≤ 25 and/or
- NIHSS score ≥ 4 and/or
- Epilepsy Balance Score ≥ 2 and/or
- HIT-6 score ≥ 48
- With functional signs and symptoms not sequellar to a previous bleeding episode AND disabling (mRS\>1)
- Ineligible for therapeutic intervention (endovascular or neurosurgery or radiosurgery)
- With normal bone marrow, liver and kidney function
- For women of childbearing potential: negative pregnancy test within 14 days of inclusion and effective contraception for up to 6 months after the end of treatment
- Having received informed consent to participate in the study
- Affiliated or beneficiary of a social security scheme
- Known allergy to bevacizumab or an excipient.
- Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies.
- Contraindication to cerebral MRI
- Absolute or relative contraindication to gadolinium injection
- Proteinuria ≥ 2+ on urine dipstick (patients with proteinuria ≥2+ on urine dipstick will need to have proteinuria ≤ 1g protein on 24-hour urine to be eligible)
- Uncontrolled hypertension (PAS \>150 and/or PAD \> 100 mmHg)
- History of hypertensive crisis or hypertensive encephalopathy
- Congestive heart failure (New York Heart Association Grade II or higher)
- Previous myocardial infarction or unstable angina in the preceding 12 months
- Symptomatic peripheral vascular disease
- Vascular disease (aortic aneurysm, aortic dissection)
- Major surgery, open biopsy or major traumatic lesion within 4 weeks prior to inclusion, or anticipation of the need for major surgery during the study.
- Biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to inclusion
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess in the 6 months prior to inclusion
- Significant unhealed wound, ulcer or bone fracture
- Thrombotic episode within 6 months prior to inclusion
- Atrial fibrillation
- Patient under legal protection
- Pregnant or breast-feeding women
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Île-de-France Region, France
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Île-de-France Region, France. 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.