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BevacizuMAV : Evaluation of the efficacy and safety of anti-angiogenic treatment with intravenous bevacizumab in patients with symptomatic cerebral arteriovenous malformations

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508464-30-00
Acronym
BevacizuMAV
Enrollment
54
Registered
2024-02-06
Start date
2024-10-24
Completion date
Unknown
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral arteriovenous malformations

Brief summary

Comparison between the two arms of the proportion of patients showing at least one of the following improvements at 6 months: Increase of at least 5 points in MoCA score / Reduction of at least 4 points in NIHSS score / Improvement of at least one stage in epilepsy balance score - Reduction of at least 12 points on HIT-6 headache score

Detailed description

Increase of at least 5 points in MoCA score between M0 and M6, Reduction of at least 4 points in NIHSS score between M0 and M6, Reduction of at least one stage in epilepsy balance score between M0 and M6, Reduction of at least 12 points in HIT-6 score between M0 and M6, Cerebral hemorrhage diagnosed by cerebral MRI at 6 months, Percentage reduction in diameter of AVM drainage veins between brain MRI at M0 and M6, Evolution of peri-MAV edema on brain MRI between M0 and M6 according to the following categorization: improvement, stable or worsening, Modified Rankin score (mRS) <2 at M6, Change in modified Rankin score (mRS) between M0 and M6, Change in EQ-5D-5L score from M0 to M6, All-cause mortality at 6 months, Evolution of plasma VEGF concentration between M0 and M6, MoCA, HIT-6, NIHSS and epilepsy balance scores at 12 months, mRS score at 12 months, EQ-5D-5L score at 12 months, Rate of occurrence of cerebral haemorrhage diagnosed by cerebral MRI at 12 months, Rate of occurrence of adverse events at 12 months

Interventions

Sponsors

Hopital Fondation Adolphe De Rothschild
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Comparison between the two arms of the proportion of patients showing at least one of the following improvements at 6 months: Increase of at least 5 points in MoCA score / Reduction of at least 4 points in NIHSS score / Improvement of at least one stage in epilepsy balance score - Reduction of at least 12 points on HIT-6 headache score

Secondary

MeasureTime frame
Increase of at least 5 points in MoCA score between M0 and M6, Reduction of at least 4 points in NIHSS score between M0 and M6, Reduction of at least one stage in epilepsy balance score between M0 and M6, Reduction of at least 12 points in HIT-6 score between M0 and M6, Cerebral hemorrhage diagnosed by cerebral MRI at 6 months, Percentage reduction in diameter of AVM drainage veins between brain MRI at M0 and M6, Evolution of peri-MAV edema on brain MRI between M0 and M6 according to the following categorization: improvement, stable or worsening, Modified Rankin score (mRS) <2 at M6, Change in modified Rankin score (mRS) between M0 and M6, Change in EQ-5D-5L score from M0 to M6, All-cause mortality at 6 months, Evolution of plasma VEGF concentration between M0 and M6, MoCA, HIT-6, NIHSS and epilepsy balance scores at 12 months, mRS score at 12 months, EQ-5D-5L score at 12 months, Rate of occurrence of cerebral haemorrhage diagnosed by cerebral MRI at 12 months, Rate of occurrence of ad

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026