CandMig III studyA scientific trial of candesartan in two diffeent doses (8 and 16 mg) as a drug for migraine preventio

Phase 1

• Conditions: Episodic migraine with and without aura; MedDRA version: 20.0Level: HLTClassification code 10027603Term: Migraine headachesSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-003386-18-EE
• Lead Sponsor: Department of Neurology and Clinical Neurophysiology, St Olavs Hospital, Trondheim University hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-22
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1.Age 18 to 64 years
2.Signed informed consent
3.Episodic migraine with or without aura according to ICHD-3 criteria(17)
4.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 randomisation to treatment .
5.Debut of migraine at least one year prior to inclusion
6.Start of migraine before age 50 years.
7. No use of other migraine prophylactics during the study
8. For women of child-bearing potential (WOCBP) there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception .
After the baseline period, just before randomisation to the study drug, inclusion criteria will be evaluated once more, and the headache diary will be evaluated. If there are, according to the headache diary, fewer attacks than 2 or more than 8 per month, the baseline period can be extended to 8 weeks, and the patient can be randomized to a treatment then if there is a mean of 2-8 attacks per 4 weeks during the 8-week’s period.
In WOCBP, a pregnancy test in the urine must be performed before start of the treatment period. The women can proceed in the study only if the test is negative.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Interval headache not distinguishable from migraine;
2)2)Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on = 15 days/month
3)Pregnancy, planning to get pregnant, nursing or inability to use contraceptives (See inclusion criteria, point 7)
4)Clinical information on or signs of cholestasis or decreased hepatic or renal function. If in doubt, relevant blood tests should be performed (See 4.2.3)
5)High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization , at the discretion of the investigator
6)Hypersensitivity to candesartan
7)History of angioneurotic edema
8)Current use of antihypertensive medication
9)Current use of potassium supplements
10)Current use of spironolactone
11)Primary hyperaldosteronism (Conn’s syndrome)
12)Significant psychiatric illness
13)Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study
14)Having tried = 3 prophylactic drugs against migraine during the last 10 years
15)Previous use of candesartan
16)Requiring detoxification from acute medication (triptans, opioids)
17)Consistently failing to respond to any acute migraine medication
18)Alcohol or illicit drug dependence.
19)Inability to understand study procedures and to comply with them for the entire length of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified