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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Active, not recruiting; Phase 2

Conditions: Migraine

Treatments: Drug: Pizotifen; Drug: Amitriptyline-propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT06158230

4292

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

140 participants in 2 patient groups

Amitriptyline-Propranolol

Active Comparator group

Description:

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

Treatment:

Drug: Amitriptyline-propranolol

Pizotifen

Experimental group

Description:

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

Treatment:

Drug: Pizotifen