Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis.

Phase 2

Active, not recruiting

• Conditions: Migraine
• Interventions: Drug: Amitriptyline-propranolol; Drug: Pizotifen

• 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

Study Timeline

• Study Start: 2023-03-19
• Status Verified: 2023-11
• Study First Submitted: 2023-11-20
• Primary Completion: 2023-11-25
• Study First Submitted QC: 2023-11-27
• Last Update Submitted: 2023-11-27
• Study First Posted: 2023-12-06
• Last Update Posted: 2023-12-06
• Study Completion: 2024-01-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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.

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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

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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