Pilot phase for the workplace migraine HeadAche Prevention Project (HAPPy - pilot) to investigate in a double blind randomised factorial trial whether treatment with low-dose combination blood pressure (BP) and cholesterol lowering therapy will reduce migraine compared to standard therapy and placebo.

Phase 4

• Conditions: Migraine; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12616000937415
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Migraine headache (with or without typical aura) according to the diagnostic criteria of the International Headache Society (IHS)
* 2-14 days per month with migraine headache averaged over past 3 months (90-days), as self-reported by subject
* Migraine symptoms must have been present for greater than or equal to 1 year prior to enrolment in the study.
* Onset of migraine symptoms must have occurred before the age of 50 years
* Adults between 18 and 65 years
* Office SBP greater than or equal to 130mmHg and DBP greater than or equal 80 mmHg
* No definite contraindications to any of the study medications at the doses used in this trial. (Subjects can be taking other preventive and therapeutic medications as long as they do not contraindicate study medication. Patients will not be eligible if they are taking medications from the same class as the study treatments)
* Is medically stable as determined by the Study Investigator
* If taking any concomitant migraine preventative medication(s), is on a stabilised dosage at the discretion of the Investigator
* Is willing to stay on current migraine preventative medication(s) for the duration of the study
* Is able to take oral medication, adhere to the medication regimens, and perform study procedures over the study duration.

Exclusion Criteria

* Contraindication to any of telmisartan, amlodipine, indapamide, rosuvastatin, ezetimibe, simvastatin or propranolol
* Concomitantly taking an angiotensin receptor blocker, angiotensin converting enzyme inhibitor, calcium channel blocker, diuretic or statin.
* Definite indication to any one or more of the study medications
* Subject has history of cluster headaches
* Subject who exclusively has migraine aura without headache, migraine with brainstem aura, hemiplegic migraine or chronic migraine
* Medication overuse headaches according to International Headache Society criteria
* Female patients who are pregnant, nursing, or those not using adequate birth control, if capable of bearing children.
* Chronic medical illnesses (e.g. lupus) that could potentially affect frequency of headache as determined by the Study Investigator
* Alcohol or substance abuse within the last year
* Any concurrent medical or psychiatric condition which, in the investigator's judgment, may interfere with study conduct or which contraindicates participation
* Abnormal creatinine, urea or electrolytes on screening.
* Inability to provide informed consent.
* Participation in a concurrent interventional medical investigation or clinical trial. Subjects in observational, natural history and/or epidemiological studies not involving an intervention are eligible.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change from baseline in mean monthly migraine headache days at 12 weeks.[Headache diary to be completed by participant; reviewed every 4 weeks, patient follow up: 12 weeks]