None listed
Conditions
Brief summary
Recurrent headache is a common, disabling condition affecting millions of Australians. Migraine is a major cause of burden of disease ranking up to 6th highest cause of major disability worldwide. Globally, an estimated 0.8 billion people suffer from migraine. Headaches are a leading cause of lost work productivity, with reduced performance rather than absence from work being the main cause of lost productive time. There would therefore be considerable value in a simple, highly tolerable preventive therapy for the large number of people suffering from frequent migraine. In the pilot phase of this trial, the key objectives are to determine the recruitment, adherence, BP and LDL differences and assess the safety of the inventions consisting of a low-dose BP lowering combination and/or a low-dose statin in participants who experience frequent migraine.
Interventions
3x3 factorial design: Participants will be randomised into a blood pressure (BP) arm and a cholesterol arm. The BP arm consists of: 1. Low-dose BP lowering combination (telmisartan 20 mg + amlodipine 2.5 mg + indapamide 1.25 mg); 2. Propranolol (160 mg/day); or 3. placebo. The cholesterol arm consists of: 1. Low-dose cholesterol lowering combination (rosuvastatin 10 mg + ezetimibe 10mg); 2. Simvastatin (20 mg/day); or 3. placebo. Medication is to be taken orally, once daily for 12 weeks. Medicat
3x3 factorial design: Participants will be randomised into a blood pressure (BP) arm and a cholesterol arm. The BP arm consists of: 1. Low-dose BP lowering combination (telmisartan 20 mg + amlodipine 2.5 mg + indapamide 1.25 mg); 2. Propranolol (160 mg/day); or 3. placebo. The cholesterol arm consists of: 1. Low-dose cholesterol lowering combination (rosuvastatin 10 mg + ezetimibe 10mg); 2. Simvastatin (20 mg/day); or 3. placebo. Medication is to be taken orally, once daily for 12 weeks. Medication usage is assessed at every follow up visit via counting remaining capsules. Any unused medication is returned at the 12 week follow up visit.
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Outcome results
None listed