Candesartan for Migraine Prevention:

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

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).

Sponsors & Collaborators

• Norwegian University of Science and Technology

  collaborator OTHER

• Nordlandssykehuset HF

  collaborator OTHER

• Molde Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Sorlandet Hospital HF

  collaborator OTHER_GOV

• University Hospital, Akershus

  collaborator OTHER

• Ullevaal University Hospital

  collaborator OTHER

• Rikshospitalet University Hospital

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• Tartu University Hospital

  collaborator OTHER

• St. Olavs Hospital

  lead OTHER

Principal Investigators

• Christian Samsonsen, md phd · St Olavs Hospital, Dept Neurology & Clinical Neurophysiology

• Jorunn L Helbostad, prof · Norwegian University of Science and Technology, Fac MH, Dept INB

• Erling Tronvik, md prof · Norwegian University of Science and Technology, Fac MH, Dept INB

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-09

Primary Completion

2024-04-12

Completion

2024-08-08

Countries

• Estonia
• Norway

Study Locations