Lovastatin for Treatment of Brain Arteriovenous Malformations

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot study is to evaluate the disease-modifying efficacy of lovastatin in patients with brain arteriovenous malformation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Treatments: Dihydromevinolin; L 647318; Lovastatin

Criteria

Inclusion Criteria:

1. Patient must have BAVM diagnosed by MRI/MRA, CTA and/or angiogram

2. BAVM deemed unsuitable for invasive treatment OR patient has elected to defer invasive treatment

3. Patient must be 18 years of age or older

4. Sign the informed consent

Exclusion Criteria:

1. Patient has received prior BAVM interventional therapy (endovascular, surgical, radiotherapy)

2. Patient has multiple-foci BAVMs

3. Patient has any form of arteriovenous or spinal fistulas

Previous diagnosis of any of the following -

4. Patient was diagnosed with Vein of Galen type malformation

5. Patient was diagnosed with cavernous malformation

6. Patient was diagnosed with dural arteriovenous fistula

7. Patient was diagnosed with venous malformation

8. Patient was diagnosed with neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome

9. Patient was diagnosed with BAVMs in context of moya-moya-type changes

10. Patient was diagnosed with hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)

11. Contraindication to an HMG-coA-reductase inhibitor

12. History of adverse reaction to HMG-coA-reductase inhibitors (rhabdomyolysis, hepatitis)

13. Use of any cholesterol lowering medication in the previous 12 weeks

Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this treatment

14. Impaired liver function with aspartate transaminase (AST) or alanine transaminase (ALT) is more than twice limit of normal.

15. Creatine kinase (CK) is more than twice limit of normal.

16. Medications that interfere with the metabolism of lovastatin

17. Gastrointestinal disease that would affect the ability to swallow or take oral medications or absorb them.

18. End stage renal disease (creatinine clearance eGFR <30 mL/min) or history of severe cardiac disease (angina, myocardial infarction or cardiac surgery in preceding two years)

19. Patient has a history of chronic alcohol or drug abuse within 2 years prior to being recruited

20. Patient has known allergy against iodine contrast agents

21. Patient is pregnant or lactating

22. Inability to provide informed consent.

23. Participation in any clinical investigation within 2 months prior to dosing