Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 :
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amitriptyline-Propranolol | Active Comparator | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pizotifen | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects of drugs | Adverse effects (e.g., somnolence, dizziness, dry mouth, weight gain, constipation, bradycardia) of study drugs will be observed | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kanuj Kumar, MD | Professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangabandhu Sheikh Mujib Medical University | Dhaka | 1200 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 23416816 | Background | 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. | |
| Background | 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. |
Not provided
Not provided
Not provided
April-2024 to March 2025
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010918 | Pizotyline |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Amitriptyline-propranolol | Drug | 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 |
|
| D009422 | Nervous System Diseases |
| D006571 |
| Heterocyclic Compounds |