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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06158230
Other study ID # 4292
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date March 19, 2023
Est. completion date January 15, 2024

Study information

Verified date November 2023
Source Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 140
Est. completion date January 15, 2024
Est. primary completion date November 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pizotifen
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
Amitriptyline-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

Locations

Country Name City State
Bangladesh Bangabandhu Sheikh Mujib Medical University Dhaka

Sponsors (1)

Lead Sponsor Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

References & Publications (3)

Chitsaz, A., Najafi, M.R., Zangeneh, F.A., Norouzi, R. and Salari, M., 2012. Pizotifen in migraine prevention: A comparison with sodium valproate. Neurology Asia, 17(4), pp.319-324.

Islam MA, Shaikh AK, AlamSkM, Sultana D, Islam MS, Rashid MM. Safety and Efficacy of Propranolol and amitriptyline combination therapy in migraine prophylaxis: A Randomized Control Trial. J NatlInstNeurosci Bangladesh, 2018;4(1): 3-7

Israil A, Ahmed S, Rahman KM, Uddin MJ, Dey SK, Battacharjee M, Mondal G, Ali MA, Alam MN, Miah AH, Uddin MS. Efficacy of amitriptyline, pizotifen and propranolol in the prevention of migraine. Mymensingh Med J. 2013 Jan;22(1):93-100. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of headache per month 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 12 weeks
Primary Duration of headache per month 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 12 weeks
Primary Severity of headache 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 12 weeks
Secondary Adverse effects of drugs Adverse effects (e.g., somnolence, dizziness, dry mouth, weight gain, constipation, bradycardia) of study drugs will be observed 12 weeks
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