None listed
Conditions
Brief summary
Recurrent headache is a common, disabling condition affecting millions of Australians. TTH has a lifetime prevalence in the general population ranging between 30 and 78%. It affects approximately 1.4 billion people globally or 20.8% of the population. 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. Therefore, there would be considerable value in a simple, highly tolerable preventive therapy for the large number of people suffering from frequent TTH. This trial aims to assess a novel low-dose BP lowering combination in this regard.
Interventions
The HAPPy Too trial is a double-blind randomised controlled trial in participants with frequent episodic tension-type headache (TTH). The duration of the trial is 16 weeks in total (12 weeks of treatment + 4 weeks of observation) with an additional 4-week screening period prior to randomisation.
The 4-week screening period will record number of headache days in that month and laboratory test results to confirm eligibility to receive study treatment. All eligible participants will be randomised a
The HAPPy Too trial is a double-blind randomised controlled trial in participants with frequent episodic tension-type headache (TTH). The duration of the trial is 16 weeks in total (12 weeks of treatment + 4 weeks of observation) with an additional 4-week screening period prior to randomisation. The 4-week screening period will record number of headache days in that month and laboratory test results to confirm eligibility to receive study treatment. All eligible participants will be randomised and followed for a period of 16 weeks. The treatment period will be for 12 weeks. Unblinding will be avoided by using a uniform medication procedure for all groups. Randomised participants who deviate from the protocol/ and or discontinue allocated BP intervention will still be followed up to 16 weeks as their data will be analysed on the ‘intention to treat’ principle. The 13 and 16 week follow ups will assess for rebound headache and hypertension. During the 12-week treatment period, participants will be randomised to one of two arms: low-dose combination of telmisartan (20mg), amlodipine (2.5mg) and indapamide (1.25mg) OR placebo. Participants will take one capsule orally, daily. The capsule will either be a low-dose combination (telmisartan + amlodipine + indapamide) or placebo. To maximise participant’s adherence to the study medications the following processes will be implemented: • Participant education during all visits on the importance of taking study medication, including timing, storage and what to do in the event of a missed dose • Participants will be instructed to return unused capsules at visit 5, week 12, and returned capsules will be counted by the study team. • Reminder text messages to commence study treatment after randomisation • Participants will be encouraged to contact a member of the study team if for any reason they are unable to continue their study medication or have missed multiple doses and are unsure whether to continue.
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
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
• Frequent episodic TTH according to the diagnostic criteria of the IHS • 2-14 days per month with headache averaged over past 3 months (90-days), as self-reported by subject • Headache must have been present for >=1 year prior to enrollment in the study. • Onset of symptoms must have occurred before the age of 50 years • Adults between 18 and 65 years • Office SBP >=130mmHg and/or DBP >=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 the patient has concomitant migraine attacks, he/she must be able to differentiate between TTH and migraine. The frequency of migraine attacks must not exceed one attack per month during the preceding year. • 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 or indapamide • Office SBP >=140mmHg and/or DBP >=90 mmHg and high CV risk • Concomitantly taking an angiotensin II receptor blocker (ARB), angiotensin-converting enzyme inhibitor (ACE-I), calcium channel blocker (CCB), or diuretic or other medications that may adversely affect potassium, sodium or creatinine. • Definite indication to any one or more of the study medications in accordance with the National Heart Foundation of Australia (NHFA) Guidelines for Diagnosis and Management of Hypertension in Adults and indications per product information sheets • Subject has history of cluster headaches • Medication overuse headaches according to IHS 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 • Clinically significant abnormal creatinine or electrolytes on screening as assessed by Study Investigator • Inability to provide informed consent. • Participation in an interventional medical investigation or clinical trial currently or within the past three months. Subjects in observational, natural history and/or epidemiological studies not involving an intervention are eligible.
Outcome results
None listed