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Candesartan for Migraine Prevention: (CandMig-3)

Primary Purpose

Migraine

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Candesartan Oral Tablet 8 mg

Candesartan Oral Tablet 16 mg

Placebo oral tablet

About this trial

This is an interventional prevention trial for Migraine focused on measuring Prevention and Control, Candesartan

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent
Episodic migraine with or without aura according to ICHD-3 criteria
At inclusion, patients should retrospectively have from 2 to 8 migraine attacks per month during the last 3 months. This frequency must be confirmed in the headache diary before randomization to treatment.
Debut of migraine at least one year prior to inclusion
Start of migraine before age 50 years
No use of other migraine prophylactics during the study
For women of child-bearing potential, use of highly effective contraception.

Exclusion Criteria:

Interval headache not distinguishable from migraine;
Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on ≥ 15 days/month
Pregnancy, planning to get pregnant, inability to use contraceptives, lactating
Clinical information on or signs of cholestasis or decreased hepatic or renal function. If in doubt, relevant blood tests should be performed
High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator
Hypersensitivity to candesartan
History of angioneurotic oedema
Current use of antihypertensive medication
Current use of potassium supplements
Current use of spironolactone
Primary hyperaldosteronism (Conn's syndrome)
Significant psychiatric illness
Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study
Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years
Previous use of candesartan
Requiring detoxification from acute medication (triptans, opioids)
Consistently failing to respond to any acute migraine medication
Alcohol or illicit drug dependence.
Inability to understand study procedures and to comply with them for the entire length of the study

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Candesartan 8 mg

Candesartan 16 mg

Control group

Arm Description

Outcomes

Primary Outcome Measures

change in number of migraine days per 4 weeks, from baseline

participants will fill in a headache diary during 20 weeks treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT04574713

First Posted

September 28, 2020

Last Updated

May 9, 2023

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology, Nordlandssykehuset HF, Molde Hospital, Haukeland University Hospital, Sorlandet Hospital HF, University Hospital, Akershus, Ullevaal University Hospital, Rikshospitalet University Hospital, University Hospital of North Norway, Tartu University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04574713

Brief Title

Candesartan for Migraine Prevention:

Acronym

CandMig-3

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 26, 2020 (Actual)

Primary Completion Date

October 15, 2024 (Anticipated)

Study Completion Date

October 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Olavs Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

Keywords

Prevention and Control, Candesartan

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

A multicentre, binational, triple blind, placebo controlled, parallel group study of two doses

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Candesartan 8 mg

Arm Type

Experimental

Arm Title

Candesartan 16 mg

Arm Type

Experimental

Arm Title

Control group

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Candesartan Oral Tablet 8 mg

Intervention Description

1 over-encapsulated tablet once daily, containing candesartan 8 mg, for 12 weeks (84 days).

Intervention Type

Drug

Intervention Name(s)

Candesartan Oral Tablet 16 mg

Intervention Description

1 over-encapsulated tablet once daily, containing candesartan 16 mg, for 12 weeks (84 days).

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Intervention Description

1 over-encapsulated tablet once daily, containing placebo, for 12 weeks (84 days).

Primary Outcome Measure Information:

Title

change in number of migraine days per 4 weeks, from baseline

Description

participants will fill in a headache diary during 20 weeks treatment

Time Frame

20 weeks plus final visit 1 week after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent Episodic migraine with or without aura according to ICHD-3 criteria At inclusion, patients should retrospectively have from 2 to 8 migraine attacks per month during the last 3 months. This frequency must be confirmed in the headache diary before randomization to treatment. Debut of migraine at least one year prior to inclusion Start of migraine before age 50 years No use of other migraine prophylactics during the study For women of child-bearing potential, use of highly effective contraception. Exclusion Criteria: Interval headache not distinguishable from migraine; Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on ≥ 15 days/month Pregnancy, planning to get pregnant, inability to use contraceptives, lactating Clinical information on or signs of cholestasis or decreased hepatic or renal function. If in doubt, relevant blood tests should be performed High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator Hypersensitivity to candesartan History of angioneurotic oedema Current use of antihypertensive medication Current use of potassium supplements Current use of spironolactone Primary hyperaldosteronism (Conn's syndrome) Significant psychiatric illness Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years Previous use of candesartan Requiring detoxification from acute medication (triptans, opioids) Consistently failing to respond to any acute migraine medication Alcohol or illicit drug dependence. Inability to understand study procedures and to comply with them for the entire length of the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Erling Tronvik, md prof

Phone

+47 40458528

erling.tronvik@ntnu.no

First Name & Middle Initial & Last Name or Official Title & Degree

Lise Rystad Øie, phd

lise.r.oie@ntnu.no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Samsonsen, md phd

Organizational Affiliation

St Olavs Hospital, Dept Neurology & Clinical Neurophysiology

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jorunn L Helbostad, prof

Organizational Affiliation

Norwegian University of Science and Technology, Fac MH, Dept INB

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Erling Tronvik, md prof

Organizational Affiliation

Norwegian University of Science and Technology, Fac MH, Dept INB

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tartu University Clinics

City

Tartu

Country

Estonia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mark Braschinsky, md phd

mark.braschinsky@kliinikum.ee

Facility Name

Haukeland University Hospital

City

Bergen

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marthe-Helene Bjørk, md phd

Marte.Bjork@uib.no

Facility Name

Nordland Hospital

City

Bodø

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karl Bjørnar Alstadhaug, md phd

Karl.Bjornar.Alstadhaug@nordlandssykehuset.no

Facility Name

Sørlandet Hospital

City

Kristiansand

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Magne Geir Bøe, md phd

magne.geir.boe@sshf.no

Facility Name

Akershus University Hospital AHUS

City

Lørenskog

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christofer Lundqvist, md phd

christofer.lundqvist@ahus.no

Facility Name

Møre and Romsdal Hospital Molde

City

Molde

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bernd Müller, md phd

Bernd.Muller@helse-mr.no

Facility Name

Rikshospitalet University Hospital

City

Oslo

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne Hege Aamodt, md phd

anhaam@ous-hf.no

Facility Name

Ullevål University Hospital

City

Oslo

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bendik Winsvold, md phd

UXWINB@ous-hf.no

Facility Name

University Hospital of North Norway

City

Tromsø

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kai Ivar Müller, md phd

Kai.Ivar.Muller@unn.no

Facility Name

St Olavs Hospital

City

Trondheim

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erling Tronvik, md phd

erling.tronvik@ntnu.no

12. IPD Sharing Statement

Learn more about this trial

Candesartan for Migraine Prevention:

We'll reach out to this number within 24 hrs

Candesartan for Migraine Prevention: (CandMig-3)

Migraine

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial