Migraine
Conditions
Brief summary
The goal of this clinical trial is to compare efficacy and observe common adverse effects of a combination of amitriptyline-propranolol and pizotifen as prophylactic treatments for migraine. The main question it aims to answer is: • Does pizotifen more effective than the combination of amitriptyline-propranolol in migraine prophylaxis? Participants will be asked to : * Maintain the provided headache diary accordingly * Take supplied drugs as described during clinical visits * Contact principle investigator if there is any issues regarding drug use and/or their adverse effects
Interventions
DRUGPizotifen
Pizotifen will be given only at night time to avoid daytime somnolence. Starting dose will be 0.5mg then gradually increased to 1.5 mg
DRUGAmitriptyline-propranolol
Amitriptyline will be given at bedtime only, starting at 10 mg daily and gradually increasing to 25 mg daily. Propranolol will be started in 40 mg daily in divided doses, which gradually increases to 80 mg daily in divided doses
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patient of migraine (with typical aura or without aura) according to ICHD-3 (International Classification of Headache Disorder, 3rd edition) criteria. 2. Age at entry: 18 to 50 years (to minimize the risks related to adverse effects of study drugs such as drowsiness, weight gain, A-V conduction block, postural hypotension) 3. Patients not on any prophylactic medications. 4. Patients willing to take part in the study. 5. Patients being able to fill a headache diary successfully & reliably.
Exclusion criteria
1. Age \<18 years or \>50 years 2. Patients having headache other than migraine, complicated migraine, ophthalmoplegic migraine, catamenial migraine, basilar migraine. 3. Patients on prophylactic medication. 4. Co-morbidities such as heart failure, hepatic or renal impairment, diabetes, bronchial asthma, malignancy, intracranial vascular aneurysm, pregnancy & breastfeeding etc. 5. Patients having known hypersensitivity to amitriptyline, propranolol or pizotifen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of headache per month | 12 weeks | Comparison of reduction of total duration of headache attack in immediate last month with initial baseline one month without any medication. These values will be compared between two study groups |
| Frequency of headache per month | 12 weeks | Comparison of reduction of frequency of headache attack in immediate last month with initial baseline one month without any medication. These values will be compared between two study groups |
| Severity of headache | 12 weeks | Comparison of reduction of severity of headache attack in immediate last month with initial baseline one month without any medication using visual analogue scale. The visual analogue scale is numbered from 0 to 10. 0 stands for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-9 for severe pain and 10 for very severe unbearable pain. These values will be compared between two study groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects of drugs | 12 weeks | Adverse effects (e.g., somnolence, dizziness, dry mouth, weight gain, constipation, bradycardia) of study drugs will be observed |
Countries
Bangladesh
Outcome results
None listed