Candesartan versus placebo for migraine prevention in patients with episodic migraine: a randomised, triple-blind, placebo-controlled, phase 2 trial
Abstract
BACKGROUND
Effective and well-tolerated preventive treatments for migraine remain few, and the angiotensin receptor blocker candesartan has shown promise in small studies. This study aimed to evaluate the safety, tolerability, and efficacy of candesartan for the preventive treatment of episodic migraine.
METHODS
This randomised, triple-blind, placebo-controlled, parallel-group, phase 2 trial was done at nine hospitals across Norway and one large hospital in Estonia, selected for their neurological services and research capacity. Adults aged 18-64 years, experiencing between two and eight migraine attacks (with or without aura) per month were randomly assigned (1:1:1) to receive oral candesartan 16 mg, candesartan 8 mg, or placebo daily for 12 weeks. Acute migraine medication was permitted during the trial but the use of other preventive treatments were prohibited. Participants, site personnel, and the trial statistician were all masked to treatment allocation. The primary endpoint was the change in the mean number of migraine days per 4 weeks from baseline to weeks 9-12, analysed in the intention-to-treat population (participants with at least one post-baseline measurement during the masked treatment period). Safety analyses included all participants who received at least one dose of the trial drug. This trial is registered with ClinicalTrials.gov (NCT04574713; Oct 5, 2020) and is completed.
FINDINGS
Between April 9, 2021, and April 12, 2024, 1340 individuals were assessed…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 457 participants or records.
Read the paper
Related studies
- Bioactive Molecules Released in Food by Lactic Acid Bacteria: Encrypted Peptides and Biogenic Amines
- A central role for amyloid fibrin microclots in long COVID/PASC: origins and therapeutic implications
- Bioaccessibility and bioavailability of phenolic compounds
- The Glutamate Hypothesis in ALS: Pathophysiology and Drug Development
- Therapeutic Approaches to Genetic Ion Channelopathies and Perspectives in Drug Discovery
- Effects of the Mediterranean Diet on the Components of Metabolic Syndrome Concerning the Cardiometabolic Risk
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.