NCT04574713

Candesartan for Migraine Prevention:

Candesartan for Migraine Prevention: A Multicentre, Binational, Triple Blind, Placebo Controlled, Parallel Group Study of Two Doses of Candesartan (8 and 16 mg)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to see whether the favorable preventative effect of candesartan 16 mg per day in episodic migraine, that was found previously in two smaller randomized controlled cross-over studies, can be confirmed in a larger, multicenter, randomized controlled parallel group study. In addition it will be investigated whether 1) also a smaller dose of 8 mg is effective, and 2) whether the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Candesartan Oral Tablet 8 mg	1 over-encapsulated tablet once daily, containing candesartan 8 mg, for 12 weeks (84 days).
DRUG	Candesartan Oral Tablet 16 mg	1 over-encapsulated tablet once daily, containing candesartan 16 mg, for 12 weeks (84 days).
DRUG	Placebo oral tablet	1 over-encapsulated tablet once daily, containing placebo, for 12 weeks (84 days).

Timeline

• Start date: 2021-04-09
• Primary completion: 2024-04-12
• Completion: 2024-08-08
• First posted: 2020-10-05
• Last updated: 2025-08-13

Locations

10 sites across 2 countries: Estonia, Norway