This Phase II, randomized, double-blind, placebo-controlled trial evaluates acetazolamide (250mg twice daily for 8 weeks) versus placebo in patients with recurrent or progressive high-grade glioma requiring dexamethasone for cerebral oedema. The primary endpoint is a composite of ≥50% corticosteroid dose reduction within 28 days, maintained for ≥7 days, without deterioration in neurological function (defined as a ≥20-point decrease in Karnofsky Performance Status). Secondary outcomes include assessment of symptoms of raised intracranial pressure (nausea, vomiting, headache), neurological function via structured examination, and adverse effects related to dexamethasone as reported by clinicians and patients/caregivers.
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: seed.study@sydney.edu.au
All participants received standard treatment with dexamethasone for their high-grade glioma. In addition, they were randomly allocated to
receive either:
Experimental Arm: Acetazolamide 250 mg tablet, taken twice a day, for 8 weeks; or
Control Arm: Placebo, taken twice a day, for 8 weeks.
Acetazolamide versus placebo for cerebral oedema requiring dexamethasone in recurrent and/or progressive
high-grade glioma: phase II randomised placebo-controlled double-blind study. BMJ Support Palliat Care. 2023
Agar MR, Nowak AK, Hovey EJ, Barnes EH, Simes J, Vardy JL, Wheeler HR, Kong BY, Leonard R, Hall M, Tim E,
Spyridopoulos D, Sim HW, Lwin Z, Dowling A, Harrup R, Jennens R, Kichenadasse G, Dunlop T, Gzell C, Koh ES.
Feb 17:spcare-2022-004119. doi: 10.1136/spcare-2022-004119. Epub ahead of print. PMID: 36807048.
https://pubmed.ncbi.nlm.nih.gov/36807048/
11 Participating Sites
30 Recruitment Target
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
