Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis: A Single-blind Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Amitriptyline-propranolol
- Conditions
- Migraine
- Sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Frequency of headache per month
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Khandakar Rashed Ahmed
Principal Investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: Amitriptyline-propranolol
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
Intervention: Pizotifen
Outcomes
Primary Outcomes
Frequency of headache per month
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Adverse effects of drugs(12 weeks)