ACED
Trial status: CompletedProtocol title
Purpose of the study
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.
Intervention
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.
Study Chair
Coordinating Centre
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: seed.study@sydney.edu.au
Design
Phase II, multi-centre, randomized, double-blind
Cancer Type
Publications
- Acetazolamide versus placebo for cerebral oedema requiring dexamethasone in recurrent and/or progressive high-grade glioma: phase II randomised placebo-controlled double-blind study. https://pubmed.ncbi.nlm.nih.gov/36807048/