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.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: 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. CONDITION: Migraine PRIMARY OUTCOME: The change from baseline in mean monthly migraine headache days at 12 weeks. SECONDARY OUTCOME: Change from baseline in diastolic BP, assessed using automated sphygmomanometer Change from baseline in health‐related quality of life (HRQoL) Change from baseline in LDL, measured from blood sample. Change from baseline in mean monthly hours with migraine Change from baseline in monthly lost productive work days due to migraine headache Change from baseline in monthly migraine headache medication treatment days Change from baseline in systolic BP, assessed using automated sphygmomanometer Change from baseline in the number of reduced productivity work hours per month Medication adherence: Self‐reported measures, pill counts Proportion of subjects with at least a 50% reduction from baseline in monthly migraine headache days Safety: Percentage with any serious adverse event (SAE) ; Self reported by participants during follow up visits. Tolerability: ; a. Difference between groups in potentially related side‐effects (dizziness, blurred vision, syncope/collapse/fall, ankle oedema, skin rash, itching, gout, hyperkalaemia, hypokalaemia, hyponatraemia; myalgia) ; b. Difference between groups in participant withdrawals from treatment ; Self reported by participants during follow up visits. 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
Epistemonikos ID: 3510e65d5a016806f9ca937f4d4273b1104fbe9e
First added on: Aug 24, 2024