Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis.
- Conditions
- Migraine
- Interventions
- Drug: Amitriptyline-propranolol
- Registration Number
- NCT06158230
- Lead Sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- Patient of migraine (with typical aura or without aura) according to ICHD-3 (International Classification of Headache Disorder, 3rd edition) criteria.
- 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)
- Patients not on any prophylactic medications.
- Patients willing to take part in the study.
- Patients being able to fill a headache diary successfully & reliably.
- Age <18 years or >50 years
- Patients having headache other than migraine, complicated migraine, ophthalmoplegic migraine, catamenial migraine, basilar migraine.
- Patients on prophylactic medication.
- Co-morbidities such as heart failure, hepatic or renal impairment, diabetes, bronchial asthma, malignancy, intracranial vascular aneurysm, pregnancy & breastfeeding etc.
- Patients having known hypersensitivity to amitriptyline, propranolol or pizotifen
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amitriptyline-Propranolol Amitriptyline-propranolol Combination of amitriptyline and propranolol. Initial 2 weeks: Amitriptyline 10 mg at bedtime Propranolol 20mg twice daily Next 2 weeks: Amitriptyline 25 mg at bedtime Propranolol 20mg three times daily Next 8 weeks: Amitriptyline 25 mg at bedtime Propranolol 40mg twice daily Pizotifen Pizotifen Pizotifen Initial 2 weeks: Pizotifen 0.5 mg at bedtime Next 2 weeks: Pizotifen 1 mg at bedtime Next 8 weeks: Pizotifen 1.5 mg at bedtime
- Primary Outcome Measures
Name Time Method 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
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
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 Outcome Measures
Name Time Method Adverse effects of drugs 12 weeks Adverse effects (e.g., somnolence, dizziness, dry mouth, weight gain, constipation, bradycardia) of study drugs will be observed
Trial Locations
- Locations (1)
Bangabandhu Sheikh Mujib Medical University
🇧🇩Dhaka, Bangladesh
Bangabandhu Sheikh Mujib Medical University🇧🇩Dhaka, Bangladesh